Code | 2194C | ||||||||||
MA number | EU/1/16/1138/007 | ||||||||||
Product Form: | tbl flm 112 (4x28)x100 mg (blis.PVC/PE/PCTFE/Al-jednotl.dávka) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | AbbVie Deutschland GmbH & Co. KG, Germany | ||||||||||
Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | blister PVC/PE/PCTFE/Al | ||||||||||
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: | 05.12.2016 |
SmPC + PL: | European Medicines Agency's database |
Safety feature | Yes |
Data update: | 30.08.2023 |