| Code | 5057D | ||||||||||
| MA number | EU/1/20/1445/001 | ||||||||||
| Product Form: | sus inj 20x0,5 ml (liek.inj.skl.) | ||||||||||
| MA Status: | Ev - Valid centralised marketing authorisation under exceptional circumstances | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Janssen - Cilag International N.V., Belgium | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
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| Shelf life: | 48 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Intramuscular use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 01.07.2020 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 03.04.2025 |
