Pregabalin Viatris (previously Pregabalin Mylan) (pregabalin)
- Region
- 🇪🇺 EU
- Active substance
- pregabalin
- Company
- Viatris Limited
- Status
- Authorised
- Therapeutic area
- Anxiety Disorders; Epilepsy
- CHMP opinion
- Wed 22 Apr 2015
- EU approval
- Wed 24 Jun 2015
- Designations
- Generic
- Application
- EMEA/H/C/004078
- ATC
- N02BF02
- Official record
- www.ema.europa.eu
Indication
Neuropathic pain Pregabalin Viatris is indicated for the treatment of peripheral and central neuropathic pain in adults. EpilepsyPregabalin Viatris is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Generalised Anxiety DisorderPregabalin Viatris is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Lyrica Authorised · Viatris EESV
- 🇪🇺 Pregabalin Viatris Pharma (previously Pregabalin Pfizer) Authorised · Viatris Healthcare Limited
- 🇪🇺 Pregabalin Zentiva Authorised · Zentiva k.s.
- 🇪🇺 Pregabalin Sandoz Authorised · Sandoz GmbH
- 🇪🇺 Pregabalin Accord Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Pregabalin Sandoz GmbH Withdrawn · Sandoz GmbH
- 🇪🇺 Pregabalin Zentiva k.s. Withdrawn · Zentiva k.s.
- 🇪🇺 Pregabalin Mylan Pharma Withdrawn · Mylan S.A.S.
Follow Pregabalin Viatris (previously Pregabalin Mylan)
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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.