Approved in 2020: Drugs for human use
On this page
- Drugs for human use: Approved in 2020
- Health categories
- Important definitions
- New drugs, new generic drugs and new biosimilar
- Alimentary tract and metabolism
- Antiinfectives for systemic use
- Antineoplastic and immunomodulating agents
- Antiparasitic products, insecticides and repellents
- Blood and blood forming organs
- Cardiovascular system
- Dermatologicals
- Genito urinary system and sex hormones
- Musculo-skeletal system
- Nervous system
- Respiratory system
- Sensory organs
- Systemic hormonal preparations, excluding sex hormones and insulin
- Various
Drugs for human use: Approved in 2020
This section outlines the new drugs, generic drugs and biosimilars approved for sale in Canada in 2020, and the safety updates issued.
Health categories
The drugs listed have been divided into categories according to the Anatomical Therapeutic Chemical Classification System, a system of codes developed by the World Health Organization. These codes are often assigned according to the mechanism of action (that is, how the drug works) rather than the disease or condition to be treated.
We have included the indication of each new drug to give you some additional information. In addition, each new drug has a hyperlink to the Decision summary (when available). These documents provide a brief overview of the rationale for our decision to approve the drug.
The categories are:
- Alimentary tract and metabolism - for example, drugs for the gastrointestinal tract and drugs for diabetes.
- Antiinfectives for systemic use - for example, antibacterials, antivirals and vaccines.
- Antineoplastic and immunomodulating agents - for example, drugs for the treatment of cancer and drugs that stimulate or suppress the immune system.
- Antiparasitic products, insecticides and repellents - for example, drugs to treat infestations of parasites.
- Blood and blood forming organs - for example, drugs such as anticoagulants.
- Cardiovascular system - for example, drugs for high blood pressure and anticholesterol agents.
- Dermatologicals - for example, drugs to treat psoriasis.
- Genito urinary system and sex hormones - for example, hormonal contraception and drugs for the urinary tract system.
- Musculo-skeletal system - for example, drugs such as anti-inflammatories and muscle relaxants.
- Nervous system - for example, analgesics and antidepressants.
- Respiratory system - for example, drugs to treat asthma and antihistamines.
- Sensory organs - for example, drugs to treat vision loss.
- Systemic hormonal preparations, excluding sex hormones and insulins - for example, drugs to treat hypothyroidism.
- Various - for example, drugs unable to be classified into the other categories such as diagnostic agents.
Important definitions
Aligned review (identified with 'AR' icon)
An aligned review is one where the drug company allowed information to be shared between Health Canada and heath technology assessment organizations.
Approved under an interim order (identified with 'IO' icon)
This indicates the drug was approved under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19.
Biologic drug (identified with 'B' icon)
Biologic drugs are biologically-derived products such as vaccines, blood-derived products and products produced through biotechnology.
Biosimilar
A biosimilar is a biologic drug that enters the market subsequent to a previously authorized biologic drug in Canada with a demonstrated similarity to the previously authorized biologic drug.
COVID-19 (identified with 'coronavirus' icon)
This indicates the drug was approved for use in the treatment or prevention of COVID-19.
Extraordinary use new drug (identified with 'EUND' icon)
Health Canada recognizes that there are circumstances in which manufacturers cannot reasonably provide substantial evidence demonstrating the safety and efficacy of a therapeutic product as there are logistical or ethical challenges in conducting the appropriate human clinical trials. For these types of products, which may be needed as part of emergency preparedness in Canada, the regulations for Extraordinary Use New Drugs (EUNDs) allow for the possibility of a market authorization based primarily on animal data. Once a product has received market authorization as an EUND, the sale of the product for that indication is restricted to federal, provincial and territorial, and municipal government(s).
Generic drug
A generic drug is a copy of a brand name product. Generic drugs contain the same medicinal ingredients as the brand name drug and are considered bioequivalent to the brand name drug. There may be many generic versions of one brand name drug. Generic drugs cost less, so approving generic drugs can mean considerable savings to the health care system.
New active substance (identified with 'NAS' icon)
A new drug that contains a medicinal ingredient not previously approved in a drug in Canada and that is not a variation of a previously approved medicinal ingredient.
New drug
New drugs give new and innovative options for treatment, prevention and diagnosis of various health conditions.
Non-prescription ("over-the-counter") drug (identified with 'OTC' icon)
Non-prescription drugs, also called over-the-counter (OTC) drugs, are products that can be bought without a doctor's prescription.
Notice of Compliance with conditions (identified with 'C' icon)
A Notice of Compliance may be issued with Conditions (NOC/c) to a drug with promising clinical benefit, for a serious, life-threatening, or severely debilitating disease or condition. The manufacturer must still demonstrate that the product has an acceptable safety profile based on a benefit/risk assessment, and is of high quality, and also commits to undertake additional studies to verify the clinical benefit of the drug. Submissions that are reviewed under this pathway are subject to shorter review targets.
Orphan drug (identified with 'O' icon)
Orphan drugs are used to treat rare diseases, and have received orphan designation in either the United States or the European Union.
Pediatric indication (identified with 'PI' icon)
This indicates that the drug has been approved for use in children less than 18 years old.
Priority review (identified with 'P' icon)
Priority review status may be granted to a drug submission for a product for a serious, life-threatening, or severely debilitating disease or condition. Submissions that are granted priority review status are subject to shorter review targets.
Review with international partners (identified with 'I' icon)
A review with international partners is one where Health Canada worked with certain regulators to share the work of drug reviews. For more information, go to "Drugs for Human Use: 2020 Accomplishments".
Safety updates
Safety updates are designed to communicate information about potential health risks, so that patients and health care professionals can make informed decisions about their health.
For more information about the types of risk communications that can be found on the Government of Canada's website, go to "Healthy clicks - Drugs for human use at a glance".
You can report adverse drug reactions to your medical professional, to a hospital or to the company that made the product. You can also report them to Health Canada through the Canada Vigilance Program or by phone at 1-866-234-2345.
New drugs, new generic drugs and new biosimilar
Figure 15: New drugs, new generic drugs and new biosimilars approved in 2020: Text description
Number of new drugs, generic drugs, and biosimilars approved in 2020, by ATC Category (the Anatomical Therapeutic Chemical Classification (ATC) System, a system of codes developed by the World Health Organization).
| ATC category | Number of new drugs approved | Number of generic drugs approved | Number of biosimilars approved |
|---|---|---|---|
| Alimentary tract and metabolism | 5 | 7 | 1 |
| Antiinfectives for systemic use | 11 | 36 | 0 |
| Antineoplastic and immunomodulating agents | 17 | 19 | 11 |
| Antiparasitic products, insecticides and repellants | 0 | 1 | 0 |
| Blood and blood forming organs | 7 | 6 | 3 |
| Cardiovascular system | 1 | 14 | 0 |
| Dermatologicals | 2 | 2 | 0 |
| Genito urinary system and sex hormones | 3 | 11 | 0 |
| Musculo-skeletal system | 1 | 4 | 0 |
| Nervous system | 11 | 23 | 0 |
| Respiratory system | 2 | 3 | 0 |
| Sensory organs | 2 | 3 | 0 |
| Systemic hormonal preparations, excluding sex hormones and insulins | 2 | 3 | 1 |
| Various | 4 | 6 | 0 |
Alimentary tract and metabolism
For example, drugs for the gastrointestinal tract and drugs for diabetes.
5 new drugs
Gilvaari
- New active substance
- Orphan drug
- Priority review
- Medicinal Ingredient
- Givosiran
- Indication
- Givlaari is used to treat acute hepatic porphyria in adults.
Isbrela
- New active substance
- Medicinal Ingredient
- Tenapanor
- Indication
- Ibsrela is used in adults (18 years of age and older) to treat a condition called irritable bowel syndrome with constipation (IBS-C).
MAR-Trientine
- New active substance
- Orphan drug
- Pediatric indication
- Medicinal Ingredient
- Trientine hydrochloride
- Indication
- MAR-Trientine is used for the treatment of Wilson's disease. It is used in patients who cannot take the drug penicillamine.
Rybelsus
- Biologic drug
- Medicinal Ingredient
- Semaglutide
- Indication
- Rybelsus contains the active substance semaglutide. It is used to lower blood sugar (glucose) in adults with type 2 diabetes. Rybelsus is used on its own if a patient's blood sugar level is not properly controlled by diet and exercise alone and they cannot use metformin. Rybelsus is used in combination with one or more other medicines for diabetes when they are not enough to control a patient's blood sugar levels.
Uceris
- Medicinal ingredient
- Budesonide
- Indication
- Uceris is used to treat mild to moderate ulcerative colitis and to get this condition under control (induced remission).
1 new biosimilar
Trurapi
- Biologic drug
- Pediatric indication
- Medicinal Ingredient
- Insulin aspart
- Indication
- Trurapi is used for the treatment of patients with diabetes mellitus who require insulin for the control of hyperglycemia (high blood sugar).
7 new generic drugs
- 1 product containing calcitriol
- 1 product containing famotidine
- 1 product containing hyoscine butylbromide
- 1 product containing loperamide hydrochloride (non-prescription drug)
- 2 products containing ondansetron
- 1 product containing prucalopride
Safety updates
- Apo-Metformin ER (extended release):
- Axid (nizatidine):
- GUM Paroex (anti-gingivitis oral rinse):
- Mesalazine-containing products:
- Metformin:
- PMS-Nystatin Oral Suspension:
- Ranitidine:
- Zofran and Zofran ODT (Oral Disintegrating Tablets) (ondansetron):
Antiinfectives for systemic use
For example, antibacterials, antivirals and vaccines.
11 new drugs
Amoxicillin Sodium and Potassium Clavulanate for Injection
- Pediatric indication
Decision summary: Amoxicillin Sodium and Potassium Clavulanate for Injection
- Medicinal Ingredients
- Amoxicillin, clavulanic acid
- Indication
- Amoxicillin Sodium and Potassium Clavulanate for Injection is used to treat certain bacterial infections including infections of the:
- nose, ear, and throat,
- respiratory tract,
- genitals and urinary tract,
- skin and soft tissue,
- bone and joints, and
- abdominal organs.
- Amoxicillin Sodium and Potassium Clavulanate for Injection is also used to help stop infections in patients having surgery.
- Amoxicillin Sodium and Potassium Clavulanate for Injection is used to treat certain bacterial infections including infections of the:
Anthim
- Biologic drug
- Extraordinary use new drug
- New active substance
- Orphan drug
- Pediatric indication
- Medicinal Ingredient
- Obiltoxaximab
- Indication
- Anthim is used along with antibiotic medicines to treat people with inhalational anthrax. Anthim can also be used to prevent anthrax disease after exposure to anthrax spores when there are no other treatment options.
The effectiveness of Anthim has been studied only in animals with inhalational anthrax. There have been no studies in people who have inhalational anthrax.
The safety of Anthim was studied in healthy adults. There have been no studies of Anthim in children younger than 18 years.
Anthim is not used in prevention or treatment of anthrax meningitis.
Bamlanivimab
- COVID-19
- Approved under an interim order
- Biologic drug
- Pediatric indication
Decision summary: Bamlanivimab
- Medicinal Ingredient
- Bamlanivimab
- Indication
- Bamlanivimab is a medicine being studied for the treatment of COVID-19. Bamlanivimab may help limit the amount of virus in a patient's body; this may help them get better faster. Bamlanivimab may be given to children 12 years of age or older who weigh at least 40 kilograms and are not already in the hospital. Bamlanivimab is only given to patients at high-risk of having the disease get worse.
Cabenuva / Vocabria
- Aligned review
- New active substance
Decision summary: Cabenuva / Vocabria
- Medicinal Ingredients
- Cabotegravir, rilpivirine / cabotegravir
- Indication
- Cabenuva is used to treat human immunodeficiency virus (HIV) infection in adults. Cabenuva replaces a patient's current HIV treatment.
- Vocabria is taken together with Edurant (rilpivirine) to treat HIV infection in adults:
- in the month before a patient begins treatment on Cabenuva to test how well they tolerate these medicines (cabotegravir and rilpivirine), and
- as a replacement for Cabenuva injections if a patient needs to miss their next scheduled injection (e.g. vacation).
COVID-19 VACCINE MODERNA
- COVID-19
- Approved under an interim order
- Biologic drug
Decision Summary: COVID-19 VACCINE MODERNA
- Medicinal Ingredient
- mRNA-1273 SARS-CoV-2
- Indication
- Moderna COVID-19 Vaccine is a vaccine used to prevent the coronavirus disease 2019 (COVID-19) caused by the SARS-CoV-2 virus. It can be given to adults aged 18 years and older.
MenQuadfi
- Biologic drug
- Pediatric indication
- Medicinal Ingredient
- Meningococcal groups a, c, w and y polysaccharide-tetanus toxoid conjugates, tetanus toxoid
- Indication
- MenQuadfi is a vaccine. It is used to help protect against infections caused by bacteria (germs) called "Neisseria meningitides" types A, C, W and Y. Neisseria meningitidis can be passed from person to person and can cause meningitis, an inflammation of the tissues that surround the brain and spinal cord, or septicemia, an infection of the blood. Both can result in serious disease with lasting effects and possibly death. MenQuadfi will not protect against disease caused by any other infectious agents.
Pfizer-BioNtech COVID-19 Vaccine
- COVID-19
- Approved under an interim order
- Biologic drug
- Pediatric indication
Decision summary: Pfizer-BioNtech COVID-19 Vaccine
- Medicinal Ingredient
- Tozinameran
- Indication
- Pfizer-BioNTech COVID-19 Vaccine is a vaccine used to prevent COVID-19 disease caused by the SARS-CoV-2 virus. Pfizer-BioNTech COVID-19 Vaccine can be given to people from 16 years of age and older.
Veklury
- COVID-19
- New active substance
- Notice of Compliance with conditions
- Pediatric indication
- Medicinal Ingredient
- Remdesivir
- Indication
- Veklury is indicated for the treatment of COVID-19 in adults and adolescents (aged 12 years and older with body weight at least 40 kilograms) with pneumonia requiring supplemental oxygen.
Vocarvi
- Medicinal Ingredient
- Foscarnet sodium
- Indication
- Vocarvi is an antiviral agent which is injected. Vocarvi is usually used to treat retinitis (inflamed condition of the eye) caused by cytomegalovirus (CMV) in patients who have acquired immunodeficiency syndrome (AIDS). Vocarvi can also be used to treat acyclovir-resistant mucocutaneous herpes simplex virus in patients who are immunocompromised (have a weak immune system).
Xenleta
- New active substance
- Priority review
- Medicinal Ingredient
- Lefamulin
- Indication
- Xenleta is used in adults to treat an infection of the lungs called community-acquired pneumonia (CAP). CAP develops in adults with limited or no contact with hospitals or healthcare centers. Adults with CAP get infected in a community setting. Antibacterial drugs like Xenleta treat only bacterial infections. They do not treat viral infections.
Xofluza
- New active substance
- Pediatric indication
- Reviewed with international partners (Australia, Switzerland)
- Medicinal Ingredient
- Baloxavir marboxil
- Indication
- Xofluza is used to treat influenza (the flu) in patients 12 years or older who have had flu symptoms for no more than 48 hours. It is given to healthy patients or patients that are more likely to have health problems from the flu.
36 new generic drugs
- 2 products containing abacavir, lamivudine
- 1 product containing amikacin
- 1 product containing amoxicillin
- 1 product containing amoxicillin, clavulanic acid
- 1 product containing azithromycin
- 1 product containing cefazolin
- 1 product containing cefepime
- 1 product containing ceftriaxone
- 2 products containing cephalexin
- 4 products containing daptomycin
- 5 products containing darunavir
- 2 products containing ertapenem
- 1 product containing itraconazole
- 1 product containing lamivudine
- 1 product containing lamivudine, zidovudine
- 1 product containing levofloxacin
- 1 product containing nitrofurantoin
- 5 products containing oseltamivir
- 1 product containing posaconazole
- 1 product containing tobramycin
- 1 product containing valganciclovir
- 1 product containing vancomycin
Safety updates
- Bacitracin for Injection:
- Bamlanivimab:
- Moderna COVID-19 Vaccine:
- Direct-acting antivirals:
- Summary Safety Review: Direct-acting antivirals - Assessing the potential risk of abnormal blood sugar levels (dysglycemia)
- Summary Safety Review: Direct-Acting Antivirals - Assessing the Potential Risk of New or Returning Liver Cancer named Hepatocellular Carcinoma
- Summary Safety Review: Direct-acting antiviral products containing a Protease Inhibitor - Assessing the Potential Risks of Hepatic Decompensation and Hepatic Failure
- Pfizer-BioNTech COVID-19 Vaccine:
- Rifampin:
- Tygacil (tigecycline):
- Valcyte (valganciclovir):
- Veklury (remdesivir):
- WinRho SDF:
Antineoplastic and immunomodulating agents
For example, drugs for the treatment of cancer and drugs that stimulate or suppress the immune system.
17 new drugs
Daurismo
- New active substance
- Orphan drug
- Medicinal Ingredient
- Glasdegib
- Indication
- Daurismo is indicated, in combination with low-dose cytarabine, for the treatment of newly diagnosed and previously untreated acute myeloid leukemia (AML) in adult patients who are age 75 years or more or who are not eligible to receive intensive induction chemotherapy.
Enspryng
- Biologic drug
- New active substance
- Orphan drug
- Pediatric indication
- Priority review
- Medicinal Ingredient
- Satralizumab
- Indication
- Enspryng is for treatment of neuromyelitis optica spectrum disorders (NMOSD). It is used in adults and young people from 12 years of age. Enspryng reduces the risk of a relapse or attack of NMOSD.
Gleolan
- Priority review
- Medicinal Ingredient
- Aminolevulinic acid hydrochloride
- Indication
- Gleolan is used to help visualize certain brain tumours (called malignant glioma) during tumour surgery.
Inqovi
- New active substance
- Orphan drug
- Reviewed with international partners (Australia, United States)
- Medicinal Ingredients
- Cedazuridine, decitabine
- Indication
- Inqovi is used to treat adults with myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML). In MDS and CMML, the bone marrow does not make enough healthy mature blood cells. MDS and CMML are types of cancer.
INREBIC
- Aligned review
- New active substance
- Orphan drug
- Medicinal Ingredient
- Fedratinib
- Indication
- It is used to treat adults with an enlarged spleen and/or the associated symptoms caused by certain types of myelofibrosis. Myelofibrosis is a rare form of blood cancer.
Mayzent
- Aligned review
- New active substance
- Medicinal Ingredient
- Siponimod
- Indication
- Mayzent is used to treat adults with a form of multiple sclerosis (MS) known as secondary progressive MS (SPMS), specifically SPMS with active disease. This means that patients still have relapses or signs of inflammation that can be seen in scans (magnetic resonance imaging, or MRI). Mayzent is used to slow down the progression of physical disability.
Nubeqa
- New active substance
- Reviewed with international partners (Australia)
- Medicinal Ingredient
- Darolutamide
- Indication
- Nubeqa is used in adults to treat prostate cancer that:
- has not spread to other parts of the body, and
- no longer responds to a medicine or surgery that lowers testosterone.
- Nubeqa has not been studied in patients with low risk of the cancer spreading to other parts of the body.
- Nubeqa is used in adults to treat prostate cancer that:
Odomzo
- Aligned review
- New active substance
Decision summary
- Medicinal Ingredient
- Sonidegib
- Indication
- Odomzo is used to treat adults with a type of skin cancer, called basal cell carcinoma. It is used when the cancer has spread to surrounding areas (called "locally advanced" basal cell carcinoma (BCC)) and it cannot be treated with surgery or radiation.
Piqray
- New active substance
- Medicinal Ingredient
- Alpelisib
- Indication
- Piqray is used to treat breast cancer, which has spread to other parts of the body, in post-menopausal women and in men. The breast cancer must be hormone receptor-positive and with a specific gene mutation (PIK3CA). Piqray is used with another drug for breast cancer called fulvestrant. This is used when the cancer gets worse after other therapies.
Polivy
- Biologic drug
- New active substance
- Notice of Compliance with conditions
- Orphan drug
- Medicinal Ingredient
- Polatuzumab vedotin
- Indication
- Polivy is given to adults to treat relapsed or refractory diffuse large B-cell lymphoma that has come back or has not responded to at least one previous therapy and who cannot receive a stem cell transplant. Diffuse large B-cell lymphoma is a cancer that develops from B-lymphocytes, a type of blood cell in the lymphatic system. Polivy is given in combination with two other medicines for cancer called rituximab and bendamustine.
Qinlock
- New active substance
- Orphan drug
- Priority review
- Reviewed with international partners (Australia, United States)
- Medicinal Ingredient
- Ripretinib
- Indication
- Qinlock is used to treat adults with gastrointestinal stromal tumor (GIST), which is a type of soft tissue cancer (sarcoma). The cancer must have been treated before with other cancer drugs for GIST including imatinib, sunitinib, and regorafenib.
Rozlytrek
- New active substance
- Notice of Compliance with conditions
- Orphan drug
- Medicinal Ingredient
- Entrectinib
- Indication
- Rozlytrek is used to treat adults with solid tumours that have a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion without a known resistance mutation. Rozlytrek can treat cancers that have spread to different parts of the body. It is for patients without other treatment options. To benefit from Rozlytrek, the patient must have a tumour that has an NTRK gene fusion. This can be checked by a test that is done before a patient starts Rozlytrek.
Rozlytrek
- Orphan drug
- Medicinal Ingredient
- Entrectinib
- Indication
- Rozlytrek is used to treat adults with a kind of lung cancer called non-small cell lung cancer (NSCLC). The non-small cell lung cancer:
- is "ROS1-positive" (this means that a patient's cancer cells have a fault in a gene called 'ROS1'),
- may have spread to other parts of a patient's body, and
- has not been treated with another drug called crizotinib.
- To benefit from Rozlytrek, the patient must have non-small cell lung cancer (NSCLC) that is ROS1-positive. This can be checked by a test that is done before a patient starts Rozlytrek.
- Rozlytrek is used to treat adults with a kind of lung cancer called non-small cell lung cancer (NSCLC). The non-small cell lung cancer:
Sarclisa
- Biologic drug
- New active substance
- Orphan drug
- Reviewed with international partners (Australia, United States)
- Medicinal Ingredient
- Isatuximab
- Indication
- Sarclisa is used in adults 18 years or older to treat a type of cancer called multiple myeloma. This is a cancer of the plasma cells which are found in the bone marrow.
Tukysa
- New active substance
- Orphan drug
- Priority review
- Reviewed with international partners (Australia, Singapore, Switzerland, United States)
- Medicinal Ingredient
- Tucatinib
- Indication
- Tukysa is used with the medications trastuzumab and capecitabine. It is used to treat adults with breast cancer that:
- is positive for human epidermal growth factor receptor 2 (HER2 positive),
- cannot be removed by surgery,
- has spread outside the breast to other parts of the body such as the brain. This is called locally advanced or metastatic disease, and
- has been treated previously with the medications trastuzumab, pertuzumab, and trastuzumab emtansine.
- Tukysa is used with the medications trastuzumab and capecitabine. It is used to treat adults with breast cancer that:
Verity-BCG
- Biologic drug
- Notice of Compliance with conditions
- Medicinal Ingredient
- Bacillus Calmette-Guérin (BCG) - strain Russian BCG-I
- Indication
- Verity-BCG contains Bacillus Calmette-Guérin. These bacteria have been weakened, so that they can be used as a safe medicine. Verity-BCG is used to treat early bladder cancer that has not invaded the muscle wall of the bladder. It is used after bladder surgery - to prevent or delay bladder cancers from growing back or spreading into the deeper layers of the bladder.
Zeposia
- Aligned review
- New active substance
- Medicinal Ingredient
- Ozanimod
- Indication
- Zeposia is used to treat adult patients with the relapsing and remitting form of multiple sclerosis (RRMS). Zeposia is not authorized for use in children.
11 new biosimilars
Amgevita
- Biologic dug
- Pediatric indication
- Medicinal Ingredient
- Adalimumab
- Indication
- Amgevita is a medicine that is used in:
- Adults with rheumatoid arthritis which is an inflammatory disease of the joints.
- Patients 2 years of age and older who have polyarticular juvenile idiopathic arthritis.
- Adults with psoriatic arthritis, which is an inflammatory disease of the joints and skin.
- Adults with ankylosing spondylitis, which is a form of arthritis.
- Adults with Crohn's disease, which is an inflammatory disease of the digestive tract.
- Children 13 to 17 years weighing 40 kg or more who have severe Crohn's disease or who have Crohn's disease which has not responded to other usual treatments.
- Adults with ulcerative colitis, which is an inflammatory disease of the bowel (colon).
- Adults or adolescents (12 to 17 years of age, weighing 30 kg or more) with moderate to severe hidradenitis suppurativa (HS) who have not responded to antibiotics. HS is a painful, progressive, chronic inflammatory skin disease that causes nodules, abscesses, sinus tracts and fistulas under the breasts, underarms, buttocks and groin.
- Adults with psoriasis, which is an inflammatory disease of the skin. A doctor may prescribe Amgevita to reduce the signs and symptoms of plaque psoriasis.
- Adults with uveitis, which is an inflammatory disease of the eye.
- Children with chronic non-infectious uveitis from 2 years of age with inflammation affecting the front of the eye.
- Patients with rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, hidradenitis suppurativa, psoriasis, or uveitis may be given other medicines for their disease before they are given Amgevita. If a patient has ulcerative colitis or Crohn's disease, they will first be given other medicines. If they do not respond well enough to these medicines, they will be given Amgevita to reduce the signs and symptoms of the disease."
- Amgevita is a medicine that is used in:
Avsola
- Aligned review
- Biologic drug
- Pediatric indication
- Medicinal Ingredient
- Infliximab
- Indication
- Avsola is a medicine that is used in people with moderate to severe rheumatoid arthritis (in combination with methotrexate) and ankylosing spondylitis. A doctor may choose to treat your rheumatoid arthritis with Avsola because a patient has moderately to severely active rheumatoid arthritis. A doctor may choose to treat ankylosing spondylitis with Avsola because a patient has had an inadequate response to other treatments or because they cannot tolerate other treatments.
- Avsola is also used in people with moderate to severe plaque psoriasis. A doctor may choose to treat plaque psoriasis with Avsola because a patient's disease is still active even though they have tried other treatments.
- Avsola is also used in people with active psoriatic arthritis. A doctor may choose to treat psoriatic arthritis with Avsola because a patient's disease is still active even though they have tried other treatments.
- Avsola is also used in adults, children and teenagers with moderate to severe Crohn's disease or with moderate to severe ulcerative colitis. A doctor may choose to treat Crohn's disease or ulcerative colitis with Avsola because a patient's disease is still active even though they have tried other treatments.
Hulio
- Biologic drug
- Pediatric indication
- Medicinal Ingredient
- Adalimumab
- Indication
- Hulio is a medicine that is used in:
- Adults with rheumatoid arthritis, which is an inflammatory disease of the joints.
- Adults with psoriatic arthritis, which is an inflammatory disease of the joints and skin.
- Adults with ankylosing spondylitis, which is a form of arthritis.
- Adults with Crohn's disease, which is an inflammatory disease of the digestive tract.
- Patients 2 years of age and older who have polyarticular juvenile idiopathic arthritis.
- Children 13 to 17 years weighing 40 kg or more who have severe Crohn's disease or who have Crohn's disease which has not responded to other usual treatments.
- Adults with ulcerative colitis, which is an inflammatory disease of the bowel (colon).
- Adults or adolescents (12 to 17 years of age, weighing 30 kg or more) with moderate to severe hidradenitis suppurativa (HS) who have not responded to antibiotics. HS is a painful, progressive, chronic inflammatory skin disease that causes nodules, abscesses, sinus tracts and fistulas under the breasts, underarms, buttocks and groin.
- Adults with psoriasis, which is an inflammatory disease of the skin. A doctor may prescribe Hulio to reduce the signs and symptoms of plaque psoriasis.
- Adults with uveitis, which is an inflammatory disease of the eye.
- Children with chronic non-infectious uveitis from 2 years of age with inflammation affecting the front of the eye.
- Patients with rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, hidradenitis suppurativa, psoriasis, or uveitis may be given other medicines for their disease before they are given Hulio. If a patient has ulcerative colitis or Crohn's disease, they will first be given other medicines. If they do not respond well enough to these medicines, they will be given Hulio to reduce the signs and symptoms of the disease.
- Hulio is a medicine that is used in:
Hyrimoz
- Biologic drug
- Pediatric indication
- Medicinal Ingredient
- Adalimumab
- Indication
- Hyrimoz is a medicine that is used in:
- Adults with rheumatoid arthritis, which is an inflammatory disease of the joints.
- Adults with psoriatic arthritis, which is an inflammatory disease of the joints and skin.
- Adults with ankylosing spondylitis, which is a form of arthritis.
- Adults with Crohn's disease, which is an inflammatory disease of the digestive tract.
- Patients 2 years of age and older who have polyarticular juvenile idiopathic arthritis.
- Adults with ulcerative colitis, which is an inflammatory disease of the bowel (colon).
- Adults with moderate to severe hidradenitis suppurativa (HS) who have not responded to antibiotics. HS is a painful, progressive, chronic inflammatory skin disease that causes nodules, abscesses, sinus tracts and fistulas under the breasts, underarms, buttocks and groin.
- Adults with psoriasis, which is an inflammatory disease of the skin. A doctor may prescribe Hyrimoz to reduce the signs and symptoms of plaque psoriasis.
- Adults with uveitis, which is an inflammatory disease of the eye.
- Patients with rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, hidradenitis suppurativa, psoriasis, or uveitis may be given other medicines for their disease before they are given Hyrimoz. If a patient has ulcerative colitis or Crohn's disease, they will first be given other medicines. If they do not respond well enough to these medicines, they will be given Hyrimoz to reduce the signs and symptoms of the disease.
- Hyrimoz is a medicine that is used in:
Idacio
- Aligned review
- Biologic drug
- Pediatric indication
- Medicinal Ingredient
- Adalimumab
- Indication
- Idacio is a medicine that is used in:
- Adults with rheumatoid arthritis, which is an inflammatory disease of the joints.
- Adults with psoriatic arthritis, which is an inflammatory disease of the joints and skin.
- Adults with ankylosing spondylitis, which is a form of arthritis.
- Adults with Crohn's disease, which is an inflammatory disease of the digestive tract.
- Patients 2 years of age and older who have polyarticular juvenile idiopathic arthritis.
- Children 13 to 17 years weighing 40 kg or more who have severe Crohn's disease or who have Crohn's disease which has not responded to other usual treatments.
- Adults with ulcerative colitis, which is an inflammatory disease of the bowel (colon).
- Adults or adolescents (12 to 17 years of age, weighing 30 kg or more) with moderate to severe hidradenitis suppurativa (HS) who have not responded to antibiotics. HS is a painful, progressive, chronic inflammatory skin disease that causes nodules, abscesses, sinus tracts and fistulas under the breasts, underarms, buttocks and groin.
- Adults with psoriasis, which is an inflammatory disease of the skin. A doctor may prescribe Idacio to reduce the signs and symptoms of plaque psoriasis.
- Adults with uveitis, which is an inflammatory disease of the eye.
- Children with chronic non-infectious uveitis from 2 years of age with inflammation affecting the front of the eye.
- Patients with rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, hidradenitis suppurativa, psoriasis, or uveitis may be given other medicines for their disease before they are given Idacio. If a patient has ulcerative colitis or Crohn's disease, they will first be given other medicines. If they do not respond well enough to these medicines, they will be given Idacio to reduce the signs and symptoms of the disease.
- Idacio is a medicine that is used in:
Kanjinti
- Biologic drug
- Medicinal Ingredient
- Trastuzumab
- Indication
- Kanjinti is a cancer medicine. Kanjinti is used to slow down the growth of specific breast cancer cells that produce large amounts of HER2 protein. It is used only for patients whose tumours are growing more rapidly than normal because of a genetic problem in the cells. This occurs in about 25 to 30% of breast cancer tumours.
- Kanjinti is used for certain patients with gastric cancer that has spread to other parts or organs of the body to slow down the growth of specific gastric cancer cells that produce large amounts of HER2 protein. Kanjinti is used in combination with chemotherapy (capecitabine or intravenous 5-fluorouracil and in combination with cisplatin) for the treatment of gastric cancer that has spread to other parts or organs of the body.
Nivestym
- Aligned review
- Biologic drug
- Pediatric indication
- Medicinal Ingredient
- Filgrastim
- Indication
- Nivestym is used to treat neutropenia, a condition where the body makes too few neutrophils. Neutropenia may be a long-standing condition where a patient's body does not make enough neutrophils, or it may be caused by drugs used to treat cancer. In some cases, the body may make enough neutrophils, but as part of the treatment for cancer, a doctor may want to increase the number of certain blood cells (CD34 cells) and collect them. The cells are collected using a process called apheresis. These collected cells are given back to the patient after they receive very high doses of treatment for cancer to make their blood counts get back to normal more quickly.
Nyvepria
- Biologic drug
- Medicinal Ingredient
- Pegfilgrastim
- Indication
- Nyvepria is used to treat neutropenia. Neutropenia is a condition where the body makes too few white blood cells and which may be caused by drugs used to treat cancer. Neutropenia is the most serious common side effect of chemotherapy. Neutropenia predisposes the body to infections and prevents a patient from fighting them. A doctor may prescribe Nyvepria to increase the number of neutrophils, which will fight infections.
Riximyo
- Biologic drug
- Medicinal Ingredient
- Rituximab
- Indication
- Riximyo is a cancer medicine that is used to stop cancer cell growth and ideally cause the death of cancer cells. It is used to treat patients with certain types of non-Hodgkin's lymphoma and chronic lymphocytic leukemia.
- Riximyo is an injectable medicine that is used to reduce signs and symptoms of rheumatoid arthritis (in combination with methotrexate).
Ruxience
- Biologic drug
- Medicinal Ingredient
- Rituximab
- Indication
- Ruxience is a cancer medicine that is used to stop cancer cell growth and ideally cause the death of cancer cells. It is used to treat patients with certain types of non-Hodgkin's lymphoma and chronic lymphocytic leukemia.
- Ruxience is an injectable medicine that is used to reduce signs and symptoms of rheumatoid arthritis (in combination with methotrexate). Ruxience in combination with glucocorticoids or steroids is also used to reduce inflammation associated with severe granulomatosis with polyangiitis (GPA, also known as Wegener's granulomatosis) and microscopic polyangiitis (MPA) and helps to control a patient's disease.
Ziextenzo
- Biologic drug
- Medicinal Ingredient
- Pegfilgrastim
- Indication
- Ziextenzo is used to treat neutropenia. Neutropenia is a condition where the body makes too few white blood cells and which may be caused by drugs used to treat cancer. Neutropenia is the most serious common side effect of chemotherapy. Neutropenia predisposes the body to infections and prevents a patient from fighting them. A doctor may prescribe Ziextenzo to increase the number of neutrophils, which will fight infections.
19 new generic drugs
- 3 products containing azacitidine
- 3 products containing bortezomib
- 2 products containing cabazitaxel
- 1 product containing cyclosporine
- 2 products containing dasatinib
- 1 product containing daunorubicin
- 1 product containing everolimus
- 1 product containing fingolimod
- 1 product containing gefitinib
- 1 product containing irinotecan hydrochloride
- 1 product containing melphalan
- 1 product containing methotrexate
- 1 product containing pemetrexed
Safety updates
- Cabazitaxel products:
- Carboplatin-containing products:
- Esbriet (pirfenidone):
- Hydrea (hydroxyurea):
- Imbruvica (ibrutinib):
- Imuran (azathioprine):
- Kyprolis (carfilzomib):
- MabCampath (alemtuzumab):
- Mekinist (trametinib) and Tafinlar (dabrafenib mesylate):
- Opdivo (nivolumab):
- Vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR TKIs):
- Xeljanz and Xeljanz XR (tofacitinib), and Jakavi (ruxolitinib) - Janus Kinase (JAK) inhibitors:
Antiparasitic products, insecticides and repellents
For example, drugs to treat infestations of parasites.
1 new generic drug
- 1 product containing hydroxychloroquine sulfate
Safety updates
- Chloroquine and hydroxychloroquine:
- Plaquenil (hydroxychloroquine sulfate):
Blood and blood forming organs
For example, drugs such as anticoagulants.
7 new drugs
Addnutriv
- Medicinal Ingredients
- Chromium, copper, fluoride, iodine, iron, manganese, molybdenum, selenium, zinc
- Indication
- Addnutriv is used along with other products that contain nutrients that are given through an infusion into a vein. It contains trace elements which are nutrients that the body needs in very small amounts. It is given to meet the body's trace element needs when a patient cannot eat normally. It is used in adults only. It prevents reduction of trace elements in the body and feeling unwell due to their lack.
Bivalirudin Injection
Decision summary: Bivalirudin Injection
- Medicinal Ingredient
- Bivalirudin
- Indication
- Bivalirudin Injection is an anticoagulant drug that is used to prevent blood from clotting. It is used in adults to treat:
- patients with ST-segment elevation myocardial infarction (STEMI (a severe type of heart attack)) undergoing percutaneous coronary intervention (PCI), (a procedure that unblocks narrowed coronary arteries without having to perform surgery), and
- patients with moderate- to high-risk acute coronary syndromes (ACS) due to unstable angina or non-ST segment elevation myocardial infarction (a type of heart attack) undergoing PCI, or who will be managed with medicines only, or who will have cardiac (heart) surgery called a coronary artery bypass graft (CABG) (sometimes referred to as "bypass" surgery).
- Bivalirudin Injection is intended for use with acetylsalicylic acid (ASA or aspirin). It can also be used instead of a drug called heparin if a patient is at risk of having low blood cell counts due to heparin.
- Bivalirudin Injection is an anticoagulant drug that is used to prevent blood from clotting. It is used in adults to treat:
Cablivi
- Biologic drug
- New active substance
- Orphan drug
- Priority review
- Medicinal Ingredient
- Caplacizumab
- Indication
- Cablivi is used to treat an episode of acquired thrombotic thrombocytopenic purpura (aTTP) in adults. aTTP is a rare blood clotting disorder in which clots form in small blood vessels. These clots can block blood vessels and damage the brain, heart, kidneys, or other organs. Cablivi prevents the formation of these blood clots by stopping platelets in the blood from clumping together.
Essepna
- Medicinal Ingredient
- Alanine, arginine, glycine, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, proline, serine, taurine, threonine, tryptophan, tyrosine, valine
- Indication
- Essepna is used along with other products that contain nutrients that are given through an infusion into a vein. It contains amino acids which are nutrients your body needs to make proteins. It is given when a patient cannot eat normally. It is used in adults only.
Reblozyl
- Biologic drug
- New active substance
- Orphan drug
- Priority review
- Medicinal Ingredient
- Luspatercept
- Indication
- Reblozyl is used to treat adults who have low red blood cell counts (anemia) and require red blood cell transfusions due to a blood disorder (β-thalassemia) that affects the production of hemoglobin (a protein in the red blood cells that transports oxygen throughout the body).
Regiocit
- Medicinal Ingredients
- Sodium chloride, sodium citrate
- Indication
- Regiocit is a solution for hemofiltration and prevents blood clotting during continuous renal replacement therapy (CRRT), which is a form or dialysis treatment. This medicine is used for critically ill patients particularly when other medicine used to prevent blood clotting is not an appropriate choice.
Tavalisse
- New active substance
- Orphan drug
- Medicinal Ingredient
- Fostamatinib
- Indication
- Tavalisse is used to treat adults with a bleeding disorder known as chronic immune thrombocytopenia when other treatments have not worked well enough.
3 new biosimilars
Inclunox, Inclunox HP
- Biologic drug
Decision summary: Inclunox, Inclunox HP
- Medicinal Ingredient
- Enoxaparin sodium
- Indication
- Inclunox is used:
- To prevent the formation of deep vein thrombosis (blood clots), which can occur as a complication of orthopedic surgery such as hip or knee surgery or of intra-abdominal (inside the body cavity below diaphragm which contains stomach, intestines, liver, and other organs) surgeries.
- To prevent the formation of deep vein thrombosis in medical patients who are at risk of thromboembolic (blockage of blood vessel by a blood clot) complications due to severely restricted mobility during acute illnesses (cardiac insufficiency (reduced ability of heart to pump blood), respiratory failure or severe chest infections).
- To treat the deep vein thrombosis with or without pulmonary embolism (blockage of blood vessel in the lungs).
- To treat the unstable angina and non-Q-wave myocardial infarction (death of a part of the heart muscle that does not involve full thickness of the heart wall), concurrently with acetylsalicylic acid (ASA).
- To treat the acute ST-segment Elevation Myocardial Infarction (STEMI), a particular form of heart attack. This indication includes patients to be managed medically or those with subsequent percutaneous coronary intervention (PCI), a procedure that opens up a coronary artery (blood vessel that brings blood and oxygen to the heart muscle) and restores blood flow.
- To prevent clotting in the extra-corporeal circulation during hemodialysis.
- Inclunox is used:
Noromby, Noromby HP
- Biologic drug
Decision summary: Noromby, Noromby HP
- Medicinal Ingredient
- Enoxaparin sodium
- Indication
- Noromby is used:
- To prevent the formation of deep vein thrombosis (blood clots), which can occur as a complication of orthopedic surgery such as hip or knee surgery or of intra-abdominal (inside the body cavity below diaphragm which contains stomach, intestines, liver, and other organs) surgeries.
- To prevent the formation of deep vein thrombosis in medical patients who are at risk of thromboembolic (blockage of blood vessel by a blood clot) complications due to severely restricted mobility during acute illnesses (cardiac insufficiency (reduced ability of heart to pump blood), respiratory failure or severe chest infections).
- To treat the deep vein thrombosis with or without pulmonary embolism (blockage of blood vessel in the lungs).
- To treat the unstable angina and non-Q-wave myocardial infarction (death of a part of the heart muscle that does not involve full thickness of the heart wall), concurrently with acetylsalicylic acid (ASA).
- To treat the acute ST-segment Elevation Myocardial Infarction (STEMI), a particular form of heart attack. This indication includes patients to be managed medically or those with subsequent percutaneous coronary intervention (PCI), a procedure that opens up a coronary artery (blood vessel that brings blood and oxygen to the heart muscle) and restores blood flow.
- To prevent clotting in the extra-corporeal circulation during hemodialysis.
- Noromby is used:
Redesca/Redesca HP
- Biologic drug
Decision summary: Redesca/Redesca HP
- Medicinal Ingredient
- Enoxaparin sodium
- Indication
- Redesca is used:
- To prevent the formation of deep vein thrombosis (blood clots), which can occur as a complication of orthopedic surgery such as hip or knee surgery or of intra-abdominal (inside the body cavity below diaphragm which contains stomach, intestines, liver, and other organs) surgeries.
- To prevent the formation of deep vein thrombosis in medical patients who are at risk of thromboembolic (blockage of blood vessel by a blood clot) complications due to severely restricted mobility during acute illnesses (cardiac insufficiency (reduced ability of heart to pump blood), respiratory failure or severe chest infections).
- To treat the deep vein thrombosis with or without pulmonary embolism (blockage of blood vessel in the lungs).
- To treat the unstable angina and non-Q-wave myocardial infarction (death of a part of the heart muscle that does not involve full thickness of the heart wall), concurrently with acetylsalicylic acid (ASA).
- To treat the acute ST-segment Elevation Myocardial Infarction (STEMI), a particular form of heart attack. This indication includes patients to be managed medically or those with subsequent percutaneous coronary intervention (PCI), a procedure that opens up a coronary artery (blood vessel that brings blood and oxygen to the heart muscle) and restores blood flow.
- To prevent clotting in the extra-corporeal circulation during hemodialysis.
- Redesca is used:
6 new generic drugs
- 1 product containing ibuprofen, pseudoephedrine hydrochloride
- 1 product containing iron
- 1 product containing prasugrel
- 3 products containing tranexamic acid
Safety updates
- Brilinta (ticagrelor):
- Summary Safety Review: Brilinta (ticagrelor) - Assessing the Potential Risks of a Worsening of a Slow and Irregular Heartbeat (Bradyarrhythmia) and Partial or Complete Block in the Transmission of Heart Impulses (Second- and Third-Degree Atrioventricular Block)
- Summary Safety Review: Brilinta (ticagrelor) - Assessing the Potential Risk of Central Sleep Apnea
- Cannabis and warfarin:
- Hemlibra (emicizumab):
Cardiovascular system
For example, drugs for high blood pressure and anticholesterol agents.
1 new drug
Corzyna
- Aligned review
- New active substance
- Priority review
- Medicinal Ingredient
- Ranolazine
- Indication
- Corzyna is a medicine used to treat chest pain (stable angina) in adults. It is used along with other medicines in patients who cannot tolerate other antianginal therapies or for whom other antianginal therapies do not work to control their chest pain (this includes beta-blockers and calcium channel blockers)
14 new generic drugs
- 1 product containing amiodarone hydrochloride
- 1 product containing atorvastatin
- 1 product containing candesartan cilexetil
- 1 product containing candesartan cilexetil, hydrochlorothiazide
- 1 product containing digoxin
- 2 products containing labetalol hydrochloride
- 1 product containing nadolol
- 1 product containing nebivolol
- 1 product containing nifedipine
- 1 product containing olmesartan medoxomil
- 2 products containing rosuvastatin
- 1 product containing sodium nitroprusside
Safety updates
- Elmiron (pentosan polysulfate sodium):
- MAR-Diltiazem CD capsules:
- Norvasc (amlodipine):
- Rythmol (propafenone hydrochloride):
Dermatologicals
For example, drugs to treat psoriasis.
2 new drugs
Duobrii
- Aligned review
- Medicinal Ingredients
- Halobetasol propionate, tazarotene
- Indication
- Duobrii is indicated for improving the signs and symptoms of plaque psoriasis in adult patients with moderate to severe plaque psoriasis.
Teva-Betamethasone/ Calcipotriol
- Medicinal Ingredients
- Betamethasone, calcipotriol
- Indication
- Teva-Betamethasone/ Calcipotriol should be used topically for up to four weeks to treat psoriasis plaques on a patient's body. Teva-Betamethasone/ Calcipotriol should not be used on the face.
2 generic drugs
- 1 product containing betamethasone, clotrimazole
- 1 product containing clobetasol propionate
Safety updates
- Picato (ingenol mebutate):
- Information Update: Use of the drug Picato may increase the risk of skin cancer
- Summary Safety Review: Picato (ingenol mebutate) - Assessing the Potential Risk of Skin Cancer
- Dear Healthcare Professional Letter: Picato (ingenol mebutate gel, 0.015% and 0.05%) - Product Withdrawal in Canada due to Potential Increased Risk of Skin Cancer
- Information Update: LEO Pharma Inc. is withdrawing the drug Picato (Ingenol mebutate), used to treat skin lesions, due to the potential increased risk of skin cancer
Genito urinary system and sex hormones
For example, hormonal contraception and drugs for the urinary tract system.
3 new drugs
Bijuva
- Medicinal Ingredients
- Estradiol, progesterone
- Indication
- Bijuva is used to reduce and relieve vasomotor symptoms (hot flashes and night sweats). It is only used in postmenopausal women with an intact uterus.
Imvexxy
- Medicinal Ingredient
- Estradiol
- Indication
- Imvexxy is used to treat postmenopausal women who experience pain before, during or after sex. This is a symptom of vulvar and vaginal atrophy. The safe and effective use of Invexxy for more than 12 weeks has not been studied.
Nexplanon
- Medicinal Ingredient
- Etonogestrel
- Indication
- Nexplanon is used to prevent pregnancy in adult women for up to three years.
11 new generic drugs
- 1 product containing clotrimazole (non-prescription drug)
- 2 products containing dienogest
- 2 products containing drospirenone, ethinyl estradiol
- 1 product containing ethinyl estradiol, norgestimate
- 1 product containing fesoterodine fumarate
- 1 product containing sildenafil
- 1 product containing tadalafil
- 1 product containing tolterodine tartrate
- 1 product containing trospium chloride
Safety updates
- Fibristal (ulipristal acetate):
Musculo-skeletal system
For example, drugs such as anti-inflammatories and muscle relaxants.
1 new drug
Zolgensma
- Aligned review
- Biologic drug
- New active substance
- Orphan drug
- Pediatric indication
- Priority review
- Medicinal Ingredient
- Onasemnogene abeparvovec
- Indication
- Zolgensma is a type of medicine called a gene therapy. It contains the active ingredient onasemnogene abeparvovec, which contains human genetic material. Zolgensma is used to treat babies and young children who have a rare, serious inherited condition called spinal muscular atrophy (SMA).
4 new generic drugs
- 1 product containing alendronic acid
- 1 product containing diphenhydramine hydrochloride, naproxen sodium
- 1 product containing indomethacin
- 1 product containing rocuronium bromide
Safety updates
- Cisatracurium Besylate Injection:
- Ibuprofen and other non-steroidal anti-inflammatory drugs (NSAIDs):
- Ibuprofen-containing products used in children:
- Pancuronium bromide injection:
- Prescription and over-the-counter non-steroidal anti-inflammatory drugs (NSAIDs):
- Quelicin (succinylcholine chloride injection):
- Rocuronium Bromide for Injection:
- Dear Healthcare Professional Letter: Importation of US-Labelled Rocuronium Bromide Injection Due to Shortage of Canadian-labelled Rocuronium
- Dear Healthcare Professional Letter: Importation of US-Labelled Rocuronium Bromide Injection distributed by Avir Pharma Inc. Due to Shortage of Canadian-labelled Rocuronium
- Dear Healthcare Professional Letter: Importation of US-Labelled Rocuronium Bromide Injection Due to Shortage of Canadian-labelled Rocuronium
- Taro-Zoledronic acid injection 5mg/100mL:
- Vecuronium bromide for injection:
Nervous system
For example, analgesics and antidepressants.
11 new drugs
Ajovy
- Biologic drug
- New active substance
- Medicinal Ingredient
- Fremanezumab
- Indication
- Ajovy is used for the prevention of migraine in adults who have at least four migraine days per month.
Dayvigo
- New active substance
- Medicinal Ingredient
- Lemborexant
- Indication
- Dayvigo is used in adults who have trouble falling asleep and/or staying asleep (insomnia). Dayvigo is not for use in children under the age of 18 years.
FIRDAPSE
- New active substance
- Orphan drug
- Priority review
- Medicinal Ingredient
- Amifampridine
- Indication
- Firdapse is used to treat the symptoms of Lambert-Eaton myasthenic syndrome (LEMS) in adults.
Kynmobi
- Medicinal Ingredient
- Apomorphine hydrochloride
- Indication
- Kynmobi is used, as needed, to treat OFF episodes in adults with Parkinson's disease. An OFF episode is when a patient's Parkinson's movement symptoms (e.g., tremor, slowness, stiffness and difficulty moving) are unexpectedly not controlled by their regular Parkinson's medication. Kynmobi is for use with other drugs to treat Parkinson's disease and does not replace the other drugs prescribed by a doctor to treat Parkinson's symptoms.
Perseris
- Medicinal Ingredient
- Risperidone
- Indication
- Perseris is used to treat schizophrenia in adults.
Peyona
- Pediatric indication
- Medicinal Ingredient
- Caffeine citrate
- Indication
- Peyona is used for the treatment of interrupted breathing (apnea) in premature babies.
Ruzurgi
- New active substance
- Orphan drug
- Pediatric indication
- Priority review
- Medicinal Ingredient
- Amifampridine
- Indication
- Ruzurgi is used to treat the symptoms of Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 years of age and older. It is not known if Ruzurgi works or is safe in children less than 6 years old.
Spravato
- Aligned review
- Priority review
- Medicinal Ingredient
- Esketamine
- Indication
- Spravato is a nasal spray used to treat adults with major depressive disorder that:
- is moderate to severe in intensity, and
- has not responded to two or more separate courses of treatment in the current episode of depression.
- Separate courses refers to previous treatment with different antidepressants, each given at adequate doses for an adequate amount of time.
- Spravato nasal spray is used together with an antidepressant taken by mouth that is either:
- a selective serotonin reuptake inhibitor (SSRI), or
- a serotonin and norepinephrine reuptake inhibitor (SNRI).
- Spravato is not for use in children or adolescents.
- If a patient is 65 years or older, they should talk to their doctor before starting Spravato. Spravato may not be an effective treatment for them and they may be more sensitive to experiencing side effects.
- Spravato is a nasal spray used to treat adults with major depressive disorder that:
Suvexx
- Medicinal Ingredients
- Naproxen sodium, sumatriptan
- Indication
- Suvexx is used in adults for the acute treatment of migraine attacks with or without aura. It should only be used in patients who have been diagnosed with migraines. Suvexx is not for preventing migraines and it is not for the treatment of cluster headaches. Suvexx is not for use in patients younger than 18 years of age.
Tomvi
- New active substance
- Medicinal Ingredient
- Etomidate
- Indication
- Tomvi is an anesthetic that is used in adults:
- to help make them asleep (unconscious) for a surgery or other medical procedure, or
- with other anesthetics to help keep them asleep for a short surgery.
- Tomvi is an anesthetic that is used in adults:
Vyndaqel
- Aligned review
- New active substance
- Orphan drug
- Priority review
- Medicinal Ingredient
- Tafamidis meglumine
- Indication
- Vyndaqel is used to treat adults with cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) to reduce death and hospitalization related to heart problems.
23 new generic drugs
- 1 product containing atomoxetine
- 1 product containing bupivacaine hydrochloride
- 2 products containing buspirone hydrochloride
- 1 product containing citalopram
- 1 product containing clomipramine hydrochloride
- 1 product containing desflurane
- 1 product containing duloxetine
- 1 product containing escitalopram
- 2 products containing fampridine
- 3 products containing fentanyl
- 2 products containing frovatriptan
- 1 product containing levetiracetam
- 1 product containing midazolam
- 1 product containing paroxetine
- 2 products containing pilocarpine hydrochloride
- 2 products containing pyridostigmine bromide
Safety updates
- Clobazam-containing products:
- Fresenius Propoven 2% (Propofol):
- HYDROmorph Contin and generic hydromorphone controlled release capsules:
- Ketamine:
- Methadone:
- Dear Healthcare Professional Letter: Methadone Treatment of Opioid Dependence and Potential Differences in Product Effect
- Dear Healthcare Professional Letter: Methadone Treatment of Opioid Dependence and Potential Risk of Lack of Effect when Switching between Different Products
- Summary Safety Review: Methadone-Containing Products Used to Treat Opioid Dependence - Assessing the Potential Risk of Lack of Effect when Switching between Different Products
- Nardil (phenelzine sulfate):
- Non-prescription pain relief products containing codeine:
- Prescription opioids:
- Sativex (delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD)):
- Tramadol-containing products:
Respiratory system
For example, drugs to treat asthma and antihistamines.
2 new drugs
Atectura Breezhaler
- Pediatric indication
Decision Summary: Atectura Breezhaler
- Medicinal Ingredients
- Indacaterol, mometasone furoate
- Indication
- Atectura Breezhaler a combination of a long-acting beta2-adrenergic agonist (LABA) and an inhaled corticosteroid (ICS). It is used to treat asthma in adults and adolescents (12 years of age and older) with reversible obstructive airways disease.
- Patients should only take this medication if their:
- asthma is not adequately controlled on a long-term asthma medication (such as a ICS), or
- disease condition requires treatment with both a LABA and ICS.
- Patients should not take this medication:
- if they can manage their asthma by occasionally using a rapid onset, short duration, inhaled beta2-agonist, or
- if they can manage their asthma by using ICS along with occasional use of a rapid onset, short duration, inhaled beta2-agonist, or
- for the relief of the sudden (acute) symptoms of asthma (i.e. as rescue therapy for the treatment of sudden episodes of bronchospasm).
Enerzair Breezhaler
Decision Summary: Enerzair Breezhaler
- Medicinal Ingredients
- Glycopyrronium, indacaterol, mometasone furoate
- Indication
- Enerzair Breezhaler is a combination of a long-acting beta2-adrenergic agonist (LABA), a long-acting muscarinic antagonist (LAMA) and an inhaled corticosteroid (ICS). It is used as a maintenance treatment for asthma in adults:
- whose asthma is not being adequately controlled with a maintenance long-acting beta2-agonist (LABA) and a medium or high dose of an inhaled corticosteroid (ICS), and
- who have experienced one or more asthma attacks in the previous year.
- Patients should not take this medication for the relief of the sudden (acute) symptoms of asthma (i.e. as rescue therapy for the treatment of sudden episodes of bronchospasm).
- Enerzair Breezhaler is a combination of a long-acting beta2-adrenergic agonist (LABA), a long-acting muscarinic antagonist (LAMA) and an inhaled corticosteroid (ICS). It is used as a maintenance treatment for asthma in adults:
3 new generic drugs
- 1 product containing cetirizine hydrochloride
- 1 product containing fluticasone propionate, salmeterol
- 1 product containing montelukast
Safety updates
- ATLAS - Codeine phosphate syrup 5 mg/mL:
- Benzodiazepines and Benzodiazepine-like prescription drugs:
- Over-the-counter benzocaine products:
- Prescription Cough and Cold Products Containing Opioids:
- Salbutamol:
- Advisory: Shortage of salbutamol inhalers in Canada
- Dear Healthcare Professional Letter: Important Safety Information - Importation of Teva UK-labelled Salamol CFC-Free (Salbutamol Sulfate) Inhaler due to Shortage
- Dear Healthcare Professional Letter: Importation of Spanish-Labelled Salbutamol Aldo-Union inhalers due to Shortage of Canadian-Labelled Salbutamol
- Singulair (montelukast):
Sensory organs
For example, drugs to treat vision loss.
2 new drugs
Beovu
- Aligned review
- Biologic drug
- New active substance
- Medicinal Ingredient
- Brolucizumab
- Indication
- Beovu is a medicine that is injected into the eye by a doctor to treat an eye disorder called neovascular (wet) age-related macular degeneration (AMD). Beovu contains the active substance brolucizumab, which belongs to a group of medicines called anti-neovascularization agents ("anti-VEGF"). Beovu is used to treat wet AMD, which occurs when abnormal blood vessels form and grow underneath the macula. The macula is located at the back of the eye, and it is responsible for clear vision. These abnormal blood vessels may be weak and leak fluid or blood in the eye. This can interfere with the macula's function, resulting in reduced vision.
Luxturna
- Aligned review
- Biologic drug
- New active substance
- Orphan drug
- Pediatric indication
- Medicinal Ingredient
- Voretigene neparvovec
- Indication
- Luxturna is used for the treatment of adults and children with vision loss due to inherited retinal dystrophy caused by mutations in the RPE65 gene. These mutations prevent the body from producing a protein needed for vision which can lead to loss of sight and eventual blindness.
3 new generic drugs
- 1 product containing brimonidine tartrate
- 1 product containing ciprofloxacin, dexamethasone
- 1 product containing travoprost
Systemic hormonal preparations, excluding sex hormones and insulin
For example, drugs to treat hypothyroidism.
2 new drugs
Increlex
- Biologic drug
- New active substance
- Orphan drug
- Pediatric indication
- Medicinal Ingredient
- Mecasermin
- Indication
- Increlex is used to treat children and adolescents from 2 to 18 years old who are very short for their age because their body does not make enough IGF-1. This condition is called primary IGF-1 deficiency. Increlex has not been studied in children younger than 2 years.
Tirosint
- Pediatric indication
- Medicinal Ingredient
- Levothyroxine sodium
- Indication
- Tirosint is used in adults and children 6 years of age and older:
- To treat hypothyroidism. This condition happens when the thyroid gland does not produce enough of the hormone, thyroxine.
- In combination with surgery and radioactive iodine therapy to treat certain types of thyroid cancer.
- Tirosint is used in adults and children 6 years of age and older:
1 new biosimilar
Osnuvo
- Biologic drug
- Medicinal Ingredient
- Teriparatide
- Indication
- Osnuvo is used to treat osteoporosis by forming new bone. Osnuvo is approved for use in both men and postmenopausal women with severe osteoporosis. Osnuvo is also approved for use in both men and women with severe osteoporosis related to use of corticosteroid medicines, such as prednisone, who are at high risk for having broken bones (fractures). These include men and women with either a history of broken bones or those with a low bone mineral density (BMD).
3 new generic drugs
- 2 products containing octreotide
- 1 product containing teriparatide
Safety updates
- Cetrotide 0.25mg:
- DDAVP Spray (desmopressin acetate nasal solution, 10 micrograms/spray):
- Propyl-Thyracil (propylthiouracil):
- Tapazole (methimazole):
Various
For example, drugs unable to be classified into the other categories such as diagnostic agents.
3 new drugs
Galliapharm
- Biologic drug
- New active substance
- Medicinal Ingredient
- Gallium 68 Ga Chloride
- Indication
- The eluate from the radionuclide generator (gallium [68Ga] chloride solution) is indicated for in vitro labelling of specific carrier molecules developed and approved for radiolabelling with such solution to be used for positron emission tomography (PET) imaging. The gallium (68Ga) chloride eluate from the GalliaPharm generator is not intended for direct use in patients.
Itulatek
- Biologic drug
- Medicinal Ingredients
- Standardized allergen extract, white birch
- Indication
- Itulatek is for adults aged 18 to 65 who are allergic to tree pollen from birch, alder and/or hazel and have allergic rhinitis (with or without conjunctivitis). Symptoms of allergic rhinitis include sneezing, runny or itchy nose, stuffed up nose (with or without symptoms of conjunctivitis such as itchy, burning, red, or watery eyes). Before a patient begins treatment with Itulatek, their allergy to tree pollen will be confirmed by a doctor who will perform skin and/or blood tests. Itulatek is NOT a medication that gives immediate relief for symptoms of tree pollen allergy.
- Itulatek has not been tested in patients younger than 12 years or older than 65 years of age. The efficacy and safety of Itulatek have not been established in subjects between the ages of 12 and 18.
Sani-Cide EX3
- Non-prescription drug
- Medicinal Ingredients
- L-lactic acid
- Indication
- Sani-Cide EX3 is used to disinfectant airplane hard, non-porous surfaces such as tray tables, armrests, lavatory door handles, galley workspaces and on any other objects or surfaces which passengers and crew may come in contact with. Sani-Cide EX3 is an effective disinfectant against Staphylococcus aureus (ATCC 6538) and Salmonella enterica (ATCC 10708).
Sodium pertechnetate 99mTc injection
- Biologic drug
- Pediatric indication
Decision Summary
- Medicinal Ingredient
- Sodium pertechnetate Tc-99m
- Indication
- Sodium pertechnetate (99mTc) may be used for preparing diagnostic radiopharmaceuticals.
6 new generic drugs
- 1 product containing calcium polystyrene sulphonate
- 1 product containing deferasirox
- 1 product containing exametazime
- 1 product containing gadopentetate dimeglumine
- 1 product containing lanthanum
- 1 product containing leucovorin
Safety update
- Dexrazoxane for Injection:
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