Pregabalin Sandoz GmbH (pregabalin)
Generic
- Region
- 🇪🇺 EU
- Active substance
- pregabalin
- Company
- Sandoz GmbH
- Status
- Withdrawn
- Therapeutic area
- Anxiety Disorders; Epilepsy
- CHMP opinion
- Thu 23 Apr 2015
- EU approval
- Fri 19 Jun 2015
- Designations
- Generic
- Application
- EMEA/H/C/004070
- ATC
- N03AX16
- Official record
- www.ema.europa.eu
Indication
Epilepsy Pregabalin Sandoz GmbH is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Generalised Anxiety Disorder Pregabalin Sandoz GmbH 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- 🇪🇺 Pregabalin Zentiva k.s. Withdrawn · Zentiva k.s.
- 🇪🇺 Pregabalin Mylan Pharma Withdrawn · Mylan S.A.S.
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