| Code | 3598E | ||||||||
| MA number | EU/1/23/1722/001 | ||||||||
| Product Form: | tbl flm 56x50 mg/500 mg (blis(PVDC/PE/PVC) | ||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||
| Type of procedure: | EU | ||||||||
| MAH, country: | Janssen - Cilag International N.V., Belgium | ||||||||
| Therapeutic Class: | 44 - CYTOSTATICA | ||||||||
| ATC: |
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| Shelf life: | 30 | ||||||||
| Container: | blister PVC/PE/PVDC | ||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10b fixed combination application |
| MA issued: | 19.04.2023 |
| Validity: | 19.04.2028 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 17.05.2023 |
