Code | 6846C | ||||||||||
MA number | EU/1/17/1245/004 | ||||||||||
Product Form: | con inf 1x24 ml/480 mg (liek.inj.skl.) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU Orphan | ||||||||||
MAH, country: | Merck Sharp & Dohme B.V., Netherland | ||||||||||
Therapeutic Class: | 42 - CHEMOTHERAPEUTICA (VRATANE TUBERKULOSTATIK) | ||||||||||
ATC: |
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Shelf life: | 30 | ||||||||||
Route of admin.: | Intravenous use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 8(3) application - new active substance |
MA issued: | 08.01.2018 |
SmPC + PL: | European Medicines Agency's database |
Safety feature | Yes |
Data update: | 09.09.2022 |