Code | 8018D | ||||||||||
MA number | EU/1/21/1556/004 | ||||||||||
Product Form: | tbl flm 14x300 mg (blis.OPA/PVC/Al) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Bristol-Myers Squibb Pharma EEIG , Ireland | ||||||||||
Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | blister OPA/Al/PVC | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 8(3) application - known active substance |
MA issued: | 17.06.2021 |
Validity: | 17.06.2026 |
SmPC + PL: |
|
Safety feature | Yes |
Data update: | 30.06.2021 |