| Code | 7544E | ||||||||||
| MA number | EU/1/24/1849/001 | ||||||||||
| Product Form: | dis inj 1x0,5 ml/50 µg (striek.inj.napl.COC v blistri) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | MODERNA BIOTECH SPAIN, S.L., Spain | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
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| Shelf life: | 12 | ||||||||||
| Container: | pre-filled syringe | ||||||||||
| Route of admin.: | Intramuscular use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10a well-established use application |
| MA issued: | 22.08.2024 |
| Validity: | 22.08.2029 |
| SmPC + PL: |
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| Safety feature | Yes |
| Data update: | 20.10.2025 |