Code | 8771D | ||||||||||
MA number | EU/1/17/1223/002 | ||||||||||
Product Form: | tbl flm 28x200 mg/50 mg/50 mg (fľ.HDPE) | ||||||||||
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: | 48 | ||||||||||
Container: | bottle HDPE | ||||||||||
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: | 26.07.2017 |
SmPC + PL: |
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Safety feature | Yes |
Data update: | 05.05.2022 |