Bromfenac (1) – Yellox®
Postoperative inflammation of the eye
Characteristics
| Start date | 01.08.2011 – Marketing authorisation: 18.05.2011 |
|---|---|
| Resolution | 19.01.2012 |
| INN | Bromfenac |
| Brand name | Yellox® |
| Pharm. company | Bausch & Lomb/Dr. Mann Pharma |
| G-BA Procedure ID | D-018 |
| ATC code | S01BC11 Antiinflammatory agents, non-steroids (S01BC) |
| ICD-10 codes (AIS) | H59.9 |
| Alpha-ID codes (AIS) | I4743Eye disease after medical measures |
| DDD | 66 mcg 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 |
|---|
|
Yellox is indicated in adults for the treatment of postoperative ocular inflammation following cataract extraction. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adult patients with postoperative ocular inflammation after cataract extraction | Dexamethasone eye drops |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (no data submitted) |
|---|---|
|
Study design
(best subpopulation) |
no data submitted (Dossier: ) |
Treatment of post-operative eye inflammation following cataract extraction in adults
- At the relevant point in time, the pharmaceutical manufacturer had not submitted a dossier to the Federal Joint Committee (G-BA) despite being requested to do so, and had therefore not provided the G-BA with the evidence required for the benefit assessment pursuant to Section 35a of Book V of the Social Code (SGB V).
- The legal consequence stipulated in Section 35a(1), fifth sentence, of SGB V is that any additional benefit is deemed not proven.
- The Federal Joint Committee (G-BA) finds that the additional benefit of bromfenac is deemed not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Bromfenac (1) | Yellox® | Bausch & Lomb/Dr. Mann Pharma | Postoperative inflammation of the eye | 850,000–1,000,000 | 100% additional benefit not proven |
<< List of all resolutions