Code | 9831B | ||||||||||
MA number | 58/0307/16-S | ||||||||||
Product Form: | tbl flm 14x1x62,5 mg (blis.PVC/PE/PVDC/Al-jednotliv.dávka) | ||||||||||
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 |
SPC: | SPC_Bosentan Cipla 125 mg_tbl flm_10_2024.pdf |
PIL: | PIL_Bosentan Cipla 125 mg_tbl flm_10_2024.pdf |
Safety feature | Yes |
Data update: | 14.12.2020 |