Details

Product Name in the RMS: Trocordis

MR Number: HU/H/0599/001
Date of outcome: 28.07.2015

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Multiple (Copy) Application Generic Chemical Substance Prescription Only
Active Substances	bosentan 62,5 mg
Form	Film coated tablet
MA Holder in the RMS	Actavis Group PTC ehf. Reykjavikurvegur 76 -78 220 Hafnarfjördur Iceland
RMS	Hungary
Date of last change	16.11.2020
ATC-Code	C02KX01 Bosentan

CMS Country	Domestic Product Name
no CMS entries available for this product

Documents
PAR:	HU_H_0599_001_PAR.pdf (31.08.2015)
PARSummary:	HU_H_0599_001_PARSummary.pdf (31.08.2015)
FinalLabelling:	HU_H_0599_001_FinalLabelling.pdf (29.07.2015)
Finalised Product Information:	HU_H_0599_001_FinalPI.pdf (16.11.2017)