Retigabin (1) – Trobalt®
Epilepsy, focal seizures
Characteristics
| Start date | 15.05.2011 – Marketing authorisation: 27.03.2011 |
|---|---|
| Resolution | 03.05.2012 repealed |
| INN | Retigabin |
| Brand name | Trobalt® |
| Pharm. company |
Dossier: GlaxoSmithKline GmbH & Co. KG
New distributor: kohlpharma GmbH |
| G-BA Procedure ID | D-008 |
| ATC code | N03AX21 Other antiepileptics (N03AX) |
| DDD | 0.9 g O |
| Therapeutic area | Nervous system diseases Epilepsy |
| Reason for procedure |
Initial assessment
Repealed by: Retigabin (3) (03.07.2014) |
| Regulatory status | authorisation withdrawn by manufacturer |
| Specialty | Patent/data protection expired |
| Therapeutic indication of the resolution |
|---|
|
Trobalt is indicated as adjunctive treatment of drug-resistant partial onset seizures with or without secondary generalization in patients aged 18 years or older with epilepsy. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adjunctive therapy for focal seizures with or without secondary generalisation in adults with epilepsy | Lamotrigine or topiramate |
Studies and Results
|
No. of studies
(best subpopulation) |
3 |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. non-ACT + ITC (MTC) |
|
Meta analysis
(best subpopulation) |
no |
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100% additional benefit not proven repealed |
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