Vihuma (simoctocog alfa)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- simoctocog alfa
- Company
- Octapharma AB
- Status
- Authorised
- Therapeutic area
- Hemophilia A
- CHMP opinion
- Thu 15 Dec 2016
- EU approval
- Mon 13 Feb 2017
- Designations
- Additional monitoring
- Application
- EMEA/H/C/004459
- ATC
- B02BD02
- Official record
- www.ema.europa.eu
Indication
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).Vihuma can be used for all age groups.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Nuwiq Authorised · Octapharma AB
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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.