| Code | 2916B | ||||||||||
| MA number | 65/0905/10-S | ||||||||||
| Product Form: | flm buc 10x400 µg (vre.COC Coex/Al/PET/lamin.pap.) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Mylan IRE Healthcare Limited, Ireland | ||||||||||
| Therapeutic Class: | 65 - ANALGETICA - ANODYNA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 24 | ||||||||||
| Route of admin.: | Buccal use |
| Prescription Status: | Medicinal product subject to special medical prescription with skew blue stripe. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 09.12.2010 |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Breakyl_06.2024.pdf
|
| PIL: |
PIL_Breakyl_06.2024.pdf
|
| Safety feature | Yes |
| Data update: | 08.02.2024 |
