Code | 6391D | ||||||||||
MA number | EU/1/20/1500/002 | ||||||||||
Product Form: | tbl flm 2x40 mg (blis.OPA/Al/PVC/Al) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Roche Registration GmbH, Germany | ||||||||||
Therapeutic Class: | 42 - CHEMOTHERAPEUTICA (VRATANE TUBERKULOSTATIK) | ||||||||||
ATC: |
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Shelf life: | 60 | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 8(3) application - new active substance |
MA issued: | 07.01.2021 |
Validity: | 07.01.2026 |
SmPC + PL: |
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Safety feature | Yes |
Data update: | 18.01.2023 |