Tag Archives: notice of compliance

Zepatier Approved in Canada

ZepatierZepatier (grazoprevir / elbasvir) is now an approved hepatitis C treatment in Canada! Health Canada has granted the treatment a Notice of Compliance (NOC) for the treatment of chronic hepatitis C (genotype 1, 3, or 4) in adult patients who have or don’t have liver cirrhosis (liver scarring).

When Zepatier will be prescribed to patients, the treatment’s regimen will depend on the genotype/type of hepatitis C virus one has, whether or not one has liver cirrhosis, and one’s treatment history (whether or not treatment has already been tried without success).

See Zepatier (grazoprevir / elbasvir) Facts for more information about Zepatier.

What a Notice of Compliance (NOC) Means for Zepatier

Receiving a Notice of Compliance allows a treatment to be sold in Canada with official approval. If a drug has a Notice of Compliance, a doctor may prescribe it – but at this stage the new drug is still not available on public drug plans, like BC PharmaCare, just private insurers. Private insurers each decide company coverage of the new drug (i.e. what percentage of the drug costs they will cover).

For more information about Zepatier (grazoprevir / elbasvir), or any other new and emerging hep C treatments, please visit PHCN’s Hepatitis C Treatment Information Project or email.

Galexos Sovaldi Combination Earns Notice of Compliance

Galexos Sovaldi pictureThe combination of Janssen’s Galexos (simeprevir) and Gilead’s Sovaldi (sofosbuvir), for the treatment of genotype 1 chronic hepatitis C in adults with compensated liver disease, has received  a notice of compliance.

the news

Receiving a notice of compliance allows the treatment to be sold in Canada with official approval. If a drug has a notice of compliance a doctor may prescribe the drug – but at this stage the new drug combination is still not available on public drug plans, like BC PharmaCare. At this stage private insurers each decide company coverage of the new drug (ie. what percentage of the drug costs they will cover).

Janssen’s Galexos has also been issued non-conditional approval for use in combination with peginterferon alfa and ribavirin for the treatment of genotype 1 chronic hepatitis C in adults with compensated liver disease.

For more information about currently approved hep C treatments in BC, new and emerging drugs, the drug approval process in Canada and BC, or hep C support programs, please visit PHCN’s Hepatitis C Treatment Information Project or email hepctip@pacifichepc.org.