Code | 9115D | ||||||||||
MA number | EU/1/21/1555/003 | ||||||||||
Product Form: | cps dur 120x100 mg (fľ.HDPE) | ||||||||||
MA Status: | Ex - Conditional centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Blueprint Medicines (Netherlands) B.V, Netherland | ||||||||||
Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | bottle HDPE | ||||||||||
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: | 18.11.2021 |
Validity: | 22.11.2024 |
SmPC + PL: |
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Safety feature | Yes |
Data update: | 29.09.2023 |