| Code | 8988D | ||||||||||
| MA number | EU/1/21/1601/001 | ||||||||||
| Product Form: | sol ijf 1x2,5 ml/300 mg + 1x2,5 ml/300 mg (liek.inj.skl.jednoráz.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Roche Registration GmbH, Germany | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
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| Shelf life: | 24 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Subcutaneous and intravenous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 12.11.2021 |
| Validity: | 12.11.2026 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 21.07.2023 |
