Pregabalin Zentiva k.s. (pregabalin)
- Region
- 🇪🇺 EU
- Active substance
- pregabalin
- Company
- Zentiva k.s.
- Status
- Withdrawn
- Therapeutic area
- Anxiety Disorders; Neuralgia; Epilepsy
- CHMP opinion
- Thu 15 Dec 2016
- EU approval
- Mon 27 Feb 2017
- Designations
- Generic
- Application
- EMEA/H/C/004277
- ATC
- N03AX16
- Official record
- www.ema.europa.eu
Indication
Neuropathic pain Pregabalin Zentiva k.s. is indicated for the treatment of peripheral and central neuropathic pain in adults. Epilepsy Pregabalin Zentiva k.s. is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Generalised anxiety disorder Pregabalin Zentiva k.s. 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
- 🇪🇺 Pregabalin Viatris (previously Pregabalin Mylan) Authorised · Viatris Limited
- 🇪🇺 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- 🇪🇺 Pregabalin Sandoz GmbH Withdrawn · Sandoz GmbH
- 🇪🇺 Pregabalin Mylan Pharma Withdrawn · Mylan S.A.S.
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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.