Maviret (glecaprevir;pibrentasvir)
Accelerated assessment
- Region
- 🇪🇺 EU
- Active substance
- glecaprevir;pibrentasvir
- Company
- AbbVie Deutschland GmbH & Co. KG
- Status
- Authorised
- Therapeutic area
- Hepatitis C, Chronic
- CHMP opinion
- Thu 22 Jun 2017
- EU approval
- Wed 26 Jul 2017
- Designations
- Accelerated assessment
- Application
- EMEA/H/C/004430
- ATC
- J05AP57
- Official record
- www.ema.europa.eu
Indication
Maviret coated granules is indicated for the treatment of acute and chronic hepatitis C virus (HCV) infection in children 3 years and older. Maviret is indicated for the treatment of acute and chronic hepatitis C virus (HCV) infection in adults and children aged 3 years and older.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.