Code | 4231E | ||||||||||
MA number | EU/1/16/1156/002 | ||||||||||
Product Form: | con inf 1x25 ml/625 mg (liek.inj.skl.) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Merck Sharp & Dohme B.V., Netherland | ||||||||||
Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
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 8(3) application - new active substance |
MA issued: | 18.01.2017 |
SmPC + PL: |
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Safety feature | Yes |
Data update: | 08.08.2023 |