| Code | 4514E | ||||||||||
| MA number | 59/0231/23-S | ||||||||||
| Product Form: | sol inj 1x1,2 ml/24 mg (liek.inj.skl.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | ONKOGEN Kft., Hungary | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
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| Shelf life: | 60 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Subcutaneous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 23.10.2023 |
| Validity: | 23.10.2028 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| PIL: |
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| SPC: |
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| Safety feature | Yes |
| Data update: | 27.03.2025 |