Code | 06611 | ||||||||||
MA number | 44/0231/11-S | ||||||||||
Product Form: | con inf 1x2 ml/2 mg (liek.inj.skl.) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | medac Gesellschaft für klinische Spezialpräparate m.b.H., Germany | ||||||||||
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 medical prescription. |
Legal basis: | Article 10(3) hybrid application |
MA issued: | 29.03.2011 |
SPC: | SPC_Topotecan medac 1 mg_ml koncentrát na infúzny roztok_09.2023.pdf |
PIL: | PIL_Topotecan medac 1 mg_ml koncentrát na infúzny roztok_09.2023.pdf |
Safety feature | Yes |
Data update: | 06.09.2023 |