Code | 0075A | ||||||||||
MA number | EU/1/11/727/001 | ||||||||||
Product Form: | sus por 1x100 ml (fľ.skl.jantár.+2 striek.inj.PET) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU Orphan | ||||||||||
MAH, country: | Nova Laboratories Ireland Limited, Ireland | ||||||||||
Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
ATC: |
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Shelf life: | 15 | ||||||||||
Container: | amber glass bottle | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 10(3) hybrid application |
MA issued: | 09.03.2012 |
SmPC + PL: |
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Safety feature | Yes |
Data update: | 17.05.2021 |