| Code | 1365D | ||||||||||
| MA number | EU/1/18/1352/001 | ||||||||||
| Product Form: | sol ira 1x0,5 ml/250 µg (pero napl. + 2 ihly) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | AOP Orphan Pharmaceuticals GmbH, Austria | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| 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: | 15.02.2019 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 22.12.2023 |
