| Code | 9834B | ||||||||||
| MA number | 58/0308/16-S | ||||||||||
| Product Form: | tbl flm 14x125 mg (blis.PVC/PE/PVDC/Al) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Cipla Europe NV, Belgium | ||||||||||
| Therapeutic Class: | 58 - HYPOTENSIVA | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| Container: | blister PVC/PE/PVDC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 15.06.2016 |
| Pediatric posology: | Yes |
| PIL: |
PIL_Bosentan Cipla 125 mg_tbl flm_10_2024.pdf
|
| SPC: |
SPC_Bosentan Cipla 125 mg_tbl flm_10_2024.pdf
|
| Safety feature | Yes |
| Data update: | 14.12.2020 |
