Code | 5484D | ||||||||||
MA number | EU/1/16/1147/016 | ||||||||||
Product Form: | tbl flm 21x75 mg (blis.PVC/OPA/Al/PVC/Al + puzdro) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Pfizer Europe MA EEIG, Belgium | ||||||||||
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 - new active substance |
MA issued: | 26.06.2020 |
SmPC + PL: | European Medicines Agency's database |
Safety feature | Yes |
Data update: | 25.05.2023 |