Code | 5714B | ||||||||||
MA number | EU/1/15/1025/001 | ||||||||||
Product Form: | tbl flm 30x300 mg/150 mg (fľ.HDPE) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Bristol-Myers Squibb Pharma EEIG , Ireland | ||||||||||
Therapeutic Class: | 42 - CHEMOTHERAPEUTICA (VRATANE TUBERKULOSTATIK) | ||||||||||
ATC: |
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Shelf life: | 24 | ||||||||||
Container: | bottle HDPE | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 10b fixed combination application |
MA issued: | 13.07.2015 |
SmPC + PL: | European Medicines Agency's database |
Safety feature | Yes |
Data update: | 17.05.2021 |