| Code | 9580E | ||||||||||
| MA number | EU/1/21/1594/003 | ||||||||||
| Product Form: | sol inj 1x14 ml/2 240 mg (liek.inj.skl.) | ||||||||||
| 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: | 18 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Subcutaneous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 09.12.2021 |
| Validity: | 27.06.2029 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 16.04.2025 |
