| 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 |
| 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: | 09.01.2025 |
