Code | 5908B | ||||||||||
MA number | EU/1/15/1030/002 | ||||||||||
Product Form: | cps dur 30x1x200 mg (blis.PCTFE/PVC/Al-perf.) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Sun Pharmaceutical Industries Europe B.V. , Netherland | ||||||||||
Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
ATC: |
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Shelf life: | 60 | ||||||||||
Container: | blister PCTFE/PVC/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: | 14.08.2015 |
SmPC + PL: |
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Safety feature | Yes |
Data update: | 29.05.2022 |