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PRODUCT DETAIL

Bosentan Cipla 62,5 mg filmom obalené tablety

Code 9830B
MA number 58/0307/16-S
Product Form: tbl flm 112x62,5 mg (blis.PVC/PE/PVDC/Al)
MA Status: D - Marketing Authorisation valid for an unlimited period
Type of procedure: Decentralised
Therapeutic Class: 58 - HYPOTENSIVA
ATC:
C CARDIOVASCULAR SYSTEM
C02 ANTIHYPERTENSIVES
C02K OTHER ANTIHYPERTENSIVES
C02KX Antihypertensives for pulmonary arterial hypertension
C02KX01 Bosentan
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 62,5 mg_11/2021.pdf  
SPC: SPC_Bosentan Cipla_04/2022.pdf  
Safety feature Yes
Data update: 14.12.2020
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