Code | 9744A | ||||||||||
MA number | EU/1/13/890/001 | ||||||||||
Product Form: | cps dur 21x20 mg (blis.PVC/PE/PCTFE-Al) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU Orphan | ||||||||||
MAH, country: | Ipsen Pharma, France | ||||||||||
Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | blister PVC/PE/PCTFE/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: | 21.03.2014 |
Validity: | 16.09.2026 |
SmPC + PL: |
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Safety feature | Yes |
Data update: | 24.10.2022 |