Code | 5004D | ||||||||||
MA number | EU/1/13/894/004 | ||||||||||
Product Form: | gra obs 28x150 mg (vre.PE/Al/PET) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Gilead Sciences Ireland UC , Ireland | ||||||||||
Therapeutic Class: | 42 - CHEMOTHERAPEUTICA (VRATANE TUBERKULOSTATIK) | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 8(3) application - new active substance |
MA issued: | 25.06.2020 |
SmPC + PL: | European Medicines Agency's database |
Dokument: | DHPC Amiodaron_HARVONI_DAKLINZA+SOVALDI 28 4 2015.pdf |
Safety feature | Yes |
Data update: | 20.07.2021 |