Liver disease

New drugs

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MaviretP,O

(new active substance)

Medical ingredient:

Glecaprevir, Pibrentasvir

Indication:

Maviret treats people with chronic (long-lasting) hepatitis C in adults. Hepatitis C is caused by an infection with the Hepatitis C virus (HCV).

For more information, see the Regulatory Decision Summary.

OcalivaP,O

(new active substance)

Medical ingredient:

Obeticholic Acid

Indication:

Ocaliva is used to treat primary biliary cholangitis (PBC).

For more information, see the Summary Basis of Decision.

Vemlidy

Medical ingredient:

Tenofovir Alafenamide Hemifumarate

Indication:

Vemlidy is used to treat chronic (long-lasting) hepatitis B in adults. Hepatitis B is caused by an infection with the hepatitis B virus (HBV)

VoseviP,O

(new active substance)

Medical ingredient:

Sofosbuvir, Velpatasvir, Voxilaprevir

Indication:

Vosevi is used to treat chronic (long-lasting) hepatitis C in adults who have:

  • genotype 1, 2, 3, 4, 5, or 6 infection and have been previously treated with a type of medicine called an NS5A inhibitor
  • genotype 1, 2, 3 or 4 infection and have been previously treated with sofosbuvir without another medicine called an NS5A inhibitor

For more information, see the Regulatory Decision Summary.

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