| Code | 9497E | ||||||||||
| MA number | EU/1/25/1913/004 | ||||||||||
| Product Form: | sol inj 10x0,5 ml (striek.inj.skl.napl.skl.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Merck Sharp & Dohme B.V., Netherland | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
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| Shelf life: | 24 | ||||||||||
| Route of admin.: | Intramuscular use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 24.03.2025 |
| Validity: | 24.03.2030 |
| SmPC + PL: |
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| Safety feature | Yes |
| Data update: | 07.04.2025 |