Code | 4545E | ||||||||||
MA number | EU/1/23/1757/002 | ||||||||||
Product Form: | tbl flm 28x345 mg (blis.Al/Al) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Stemline Therapeutics B.V., Netherland | ||||||||||
Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
ATC: |
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Shelf life: | 24 | ||||||||||
Container: | blister Al/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: | 15.09.2023 |
Validity: | 15.09.2028 |
SmPC + PL: | European Medicines Agency's database |
Safety feature | Yes |
Data update: | 11.10.2023 |