| Code | 4293E | ||||||||||
| MA number | EU/1/23/1748/001 | ||||||||||
| Product Form: | sol inj 1x1,5 ml/3 mg (liek.inj.skl.) | ||||||||||
| MA Status: | Ex - Conditional centralised marketing authorisation | ||||||||||
| Type of procedure: | EU Orphan | ||||||||||
| Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 18 | ||||||||||
| 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: | 21.08.2023 |
| Validity: | 21.08.2024 |
| SmPC + PL: |
European Medicines Agency's database
|
| Dokument: |
Talvey_Karta pacienta.pdf
|
| Dokument: |
Talvey_Edukačný materiál pre zdravotníckych pracovníkov.pdf
|
| Safety feature | Yes |
| Data update: | 19.12.2023 |
