Code | 2003E | ||||||||||
MA number | EU/1/22/1675/002 | ||||||||||
Product Form: | sol inj 1x1,7 ml/153 mg (liek.inj.skl.) | ||||||||||
MA Status: | Ex - Conditional centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
ATC: |
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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: | 23.08.2022 |
Validity: | 24.08.2024 |
SmPC + PL: | European Medicines Agency's database |
Dokument: | Tecvayli_Karta pacienta.pdf |
Safety feature | Yes |
Data update: | 13.10.2023 |