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 |
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no CMS entries available for this product |
Documents | |
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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) |