| Code | 5684B | ||||||||||
| MA number | EU/1/13/839/005 | ||||||||||
| Product Form: | tbl flm 30x15 mg (fľ.HDPE) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU Orphan | ||||||||||
| MAH, country: | Incyte Biosciences Distribution B.V., Netherland | ||||||||||
| Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| 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: | 01.07.2013 |
| SmPC + PL: |
European Medicines Agency's database
|
| Dokument: |
DHPC letter_BCR-ABLTKIs_SK 11 4 2016.pdf
|
| Safety feature | Yes |
| Data update: | 20.07.2021 |
