Fingolimod Accord (fingolimod)
- Region
- 🇪🇺 EU
- Active substance
- fingolimod
- Company
- Accord Healthcare S.L.U.
- Status
- Authorised
- Therapeutic area
- Multiple Sclerosis, Relapsing-Remitting
- CHMP opinion
- Thu 30 Apr 2020
- EU approval
- Thu 25 Jun 2020
- Designations
- Generic
- Application
- EMEA/H/C/005191
- ATC
- L04AA27
- Official record
- www.ema.europa.eu
Indication
Indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult patients and paediatric patients aged 10 years and older: Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy or Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Gilenya Authorised · Novartis Europharm Limited
- 🇪🇺 Fingolimod Mylan Authorised · Mylan Pharmaceuticals Limited
- 🇪🇺 Fingolimod Mylan Application withdrawn · Mylan Ireland Limited
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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.