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PRODUCT DETAIL

Bosentan Gen.Orph 62,5 mg filmom obalené tablety

Code 1238D
MA number 58/0111/19-S
Product Form: tbl flm 56x62,5 mg (blis.PVC/Al)
MA Status: R - Valid Marketing Authorisation
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: 36
Container: blister PVC/Al
Route of admin.: Oral use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 10(1) generic application
MA issued: 26.04.2019
Validity: 26.04.2024
Pediatric posology: Yes
SPC: SPC_Bosentan Gen.Orph 62,5 mg_tbl flm_04/2019_REG.doc  
PIL: PIL_Bosentan Gen.Orph_62,5 mg_tbl flm_04/2019_REG.doc  
Safety feature Yes
Data update: 11.06.2019
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