Paxlovid (nirmatrelvir;ritonavir)
- Region
- 🇪🇺 EU
- Active substance
- nirmatrelvir;ritonavir
- Company
- Pfizer Europe MA EEIG
- Status
- Authorised
- Therapeutic area
- COVID-19 virus infection
- CHMP opinion
- Thu 27 Jan 2022
- EU approval
- Fri 28 Jan 2022
- Application
- EMEA/H/C/005973
- ATC
- J05AE30
- Official record
- www.ema.europa.eu
Indication
Paxlovid is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults and paediatric patients 6 years of age and older weighing at least 20 kg who do not require supplemental oxygen and who are at increased risk for progressing to severe COVID 19 (see section 5.1).
Regulatory milestones
No milestones recorded in the last year.
Follow Paxlovid
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.