Code | 7748D | ||||||||||
MA number | EU/1/21/1542/002 | ||||||||||
Product Form: | cps dur 56 (2x28) x 25 mg (lis.PVC/PE/PCTFE/Al) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Secura Bio Limited, Ireland | ||||||||||
Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
ATC: |
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Shelf life: | 60 | ||||||||||
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: | 19.05.2021 |
Validity: | 19.05.2026 |
SmPC + PL: |
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Safety feature | Yes |
Data update: | 28.05.2021 |