Fingolimod Mylan (fingolimod)
- Region
- 🇪🇺 EU
- Active substance
- fingolimod
- Company
- Mylan Pharmaceuticals Limited
- Status
- Authorised
- Therapeutic area
- Multiple Sclerosis, Relapsing-Remitting
- CHMP opinion
- Thu 25 Jun 2020
- EU approval
- Wed 18 Aug 2021
- Designations
- Generic
- Application
- EMEA/H/C/005661
- ATC
- L04AE01
- 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 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 (for exceptions and information about washout periods see sections 4.4 and 5.1) 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
- 🇪🇺 Fingolimod Accord Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Gilenya Authorised · Novartis Europharm 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- 🇪🇺 Fingolimod Mylan Application withdrawn · Mylan Ireland Limited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.