| Code | 2399C | ||||||||||
| MA number | 78/0541/16-S | ||||||||||
| Product Form: | cps dur 14x25 mg (blis.PA/Al/PVC/Al) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Egis Pharmaceuticals PLC, Hungary | ||||||||||
| Therapeutic Class: | 78 - SYMPATHOMIMETICA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 30 | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 23.12.2016 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Bitinex_10.2024.pdf
|
| SPC: |
SPC_Bitinex_10.2024.pdf
|
| Safety feature | Yes |
| Data update: | 30.08.2021 |
