Fampridine Accord (fampridine)
Generic
- Region
- 🇪🇺 EU
- Active substance
- fampridine
- Company
- Accord Healthcare S.L.U.
- Status
- Authorised
- Therapeutic area
- Multiple Sclerosis
- CHMP opinion
- Thu 23 Jul 2020
- EU approval
- Thu 24 Sep 2020
- Designations
- Generic
- Application
- EMEA/H/C/005359
- ATC
- N07XX07
- Official record
- www.ema.europa.eu
Indication
Fampridine Accord is indicated for the improvement of walking in adult patients with multiple sclerosis with walking disability (EDSS 4-7).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Fampyra Authorised · Merz Therapeutics GmbH
- 🇪🇺 Firdapse (previously Zenas) Authorised · SERB SA
- 🇪🇺 Amifampridine SERB Authorised · SERB SA
Follow Fampridine Accord
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.