Nepafenac (1) – Nevanac®
Postoperative pain after eye surgery
Characteristics
| Start date | 01.07.2013 – Marketing authorisation: 11.12.2007 |
|---|---|
| Resolution | 19.12.2013 |
| INN | Nepafenac |
| Brand name | Nevanac® |
| Pharm. company |
Dossier: Alcon Pharma GmbH
New distributor: CRANACH-PHARMA GmbH |
| G-BA Procedure ID | D-070 |
| ATC code | S01BC10 Antiinflammatory agents, non-steroids (S01BC) |
| ICD-10 codes (AIS) | H59.9 |
| Alpha-ID codes (AIS) | I4743Eye disease after medical measures |
| DDD | 0.15 mg eye drops |
| Therapeutic area | Eye diseases Postoperative eye inflammation after cataract extraction |
| Reason for procedure | Initial assessment |
| Specialty | Patent/data protection expired |
| Therapeutic indication of the resolution |
|---|
|
NEVANAC 1 mg/ml is indicated in adults for: - Prevention and treatment of postoperative pain and inflammation associated with cataract surgery - Reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adult patients with postoperative pain and inflammation associated with cataract surgery and adult diabetic patients at risk for postoperative macular edema associated with cataract surgery | Diclofenac eye drops |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (no data submitted) |
|---|---|
|
Study design
(best subpopulation) |
no data submitted (Dossier: ) |
a) Patients for the prevention and treatment of post-operative pain and inflammation following cataract surgery
- As the necessary evidence has not been provided in full, the additional benefit in relation to the appropriate comparator therapy is deemed not proven (Section 35a(1), fifth sentence, of Book V of the Social Code [SGB V]).
b) Patients for the reduction of the risk of post-operative macular oedema associated with cataract surgery in diabetic patients
- As the necessary evidence has not been submitted in full, the additional benefit in relation to the appropriate comparator therapy is deemed not proven (Section 35a(1), fifth sentence, SGB V).
Courtesy translation only, please refer to the German original.
Associated procedures
| Nepafenac (1) | Nevanac® | Alcon Pharma GmbH | Postoperative pain after eye surgery | 850,000–1,000,000 | 100% additional benefit not proven |
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