Code | 0296C | ||||||||||
MA number | EU/1/07/422/014 | ||||||||||
Product Form: | cps dur 392(14x28)x200 mg (blis.PVC/PVDC/Al) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Novartis Europharm Limited, Ireland | ||||||||||
Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 8(3) application |
MA issued: | 28.09.2011 |
SmPC + PL: | European Medicines Agency's database |
Dokument: | DHPC letter_BCR-ABLTKIs_SK 11 4 2016.pdf |
Safety feature | Yes |
Data update: | 09.08.2022 |