Code | 1535C | ||||||||||
MA number | EU/1/16/1130/001 | ||||||||||
Product Form: | con dsf 1x10 ml/43 mg (liek.inj.skl.) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU Orphan | ||||||||||
MAH, country: | Les Laboratoires Servier, France | ||||||||||
Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | glass vial | ||||||||||
Route of admin.: | Intravenous use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 8(3) application - known active substance |
MA issued: | 14.10.2016 |
SmPC + PL: |
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Safety feature | Yes |
Data update: | 12.10.2022 |