| Code | 4819C | ||||||||||
| MA number | EU/1/17/1213/001 | ||||||||||
| Product Form: | tbl flm 84 (4x21)x100 mg/40 mg (blis.PVC/PE/PCTFE/Al) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | AbbVie Deutschland GmbH & Co. KG, Germany | ||||||||||
| 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: | 26.07.2017 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 28.03.2022 |
