| Code | 5315D | ||||||||||
| MA number | EU/1/14/958/005 | ||||||||||
| Product Form: | gra obs 28x45 mg/200 mg (vre.PET/Al/PE) | ||||||||||
| 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: |
|
||||||||||
| 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: | 03.07.2020 |
| SmPC + PL: |
European Medicines Agency's database
|
| Dokument: |
DHPC Amiodaron_HARVONI_DAKLINZA+SOVALDI 28 4 2015.pdf
|
| Safety feature | Yes |
| Data update: | 07.09.2021 |
