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) |
| DDD | 66 mcg eye drops |
| Therapeutic area | Eye diseases |
| Reason for procedure | Initial assessment |
Studies and Results
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 |
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