| Code | 5229E | ||||||||||
| MA number | EU/1/23/1770/001 | ||||||||||
| Product Form: | sol inj 1x1,1 ml/44 mg (liek.inj.skl.) | ||||||||||
| MA Status: | Ex - Conditional centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Pfizer Europe MA EEIG, Belgium | ||||||||||
| Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 24 | ||||||||||
| Container: | glass vial | ||||||||||
| 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: | 07.12.2023 |
| Validity: | 08.12.2025 |
| SmPC + PL: |
European Medicines Agency's database
|
| Dokument: |
Elrexfio_Karta pacienta.pdf
|
| Safety feature | Yes |
| Data update: | 07.05.2025 |
