Retigabin (1) – Trobalt®
Epilepsy, focal seizures
Characteristics
| Start date | 15.05.2011 – Marketing authorisation: 27.03.2011 |
|---|---|
| Resolution | 03.05.2012 |
| INN | Retigabin |
| Brand name | Trobalt® |
| Pharm. company | GlaxoSmithKline GmbH & Co. KG |
| G-BA Procedure ID | D-008 |
| ATC code | N03AX21 Other antiepileptics (N03AX) |
| DDD | 0.9 g O |
| Therapeutic area | Nervous system diseases |
| Reason for procedure |
Initial assessment
Reassessed in: Retigabin (3) (03.07.2014) |
| Regulatory status | authorisation withdrawn by manufacturer |
Studies and Results
Patients receiving monotherapy with lamotrigine
- On this basis, and taking into account the comments received and the oral hearing, the G-BA has reached the following assessment:
Courtesy translation only, please refer to the German original.
Associated procedures
| Retigabin (3) | Trobalt® | GlaxoSmithKline GmbH & Co. KG | Epilepsy, focal seizures | 26,800–53,600 | 100% additional benefit not proven | |
| Retigabin (2) | Trobalt® | GlaxoSmithKline GmbH & Co. KG | Epilepsy, focal seizures | n.d. | discontinued | |
| Retigabin (1) | Trobalt® | GlaxoSmithKline GmbH & Co. KG | Epilepsy, focal seizures |
0
85,000–175,000 |
100% additional benefit not proven repealed subpopulations |
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