Code | 2192B | ||||||||||
MA number | EU/1/14/938/001 | ||||||||||
Product Form: | tbl flm 60x100 mg (fľ.HDPE) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Gilead Sciences Ireland UC , Ireland | ||||||||||
Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
ATC: |
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Shelf life: | 60 | ||||||||||
Container: | bottle HDPE | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 8(3) application - new active substance |
MA issued: | 18.09.2014 |
Validity: | 19.09.2024 |
SmPC + PL: | European Medicines Agency's database |
Dokument: | DHCP_Zydelig (PRINT) 17 8 2016.pdf |
Dokument: | DHPC Zydelig 22 3 2016.pdf |
Safety feature | Yes |
Data update: | 14.10.2021 |