| Code | 9115E | ||||||||||
| MA number | EU/1/24/1885/002 | ||||||||||
| Product Form: | sol inj 3(3x1)x1,2 ml/200 mg (striek.inj.skl.napl. - jednotk.multibal.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | CSL Behring GmbH, Germany | ||||||||||
| Therapeutic Class: | 87 - VARIA I | ||||||||||
| ATC: |
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| Shelf life: | 36 | ||||||||||
| 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: | 10.02.2025 |
| Validity: | 10.02.2030 |
| SmPC + PL: |
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| Safety feature | Yes |
| Data update: | 03.03.2025 |