Code | 2651E | ||||||||||
MA number | EU/1/22/1688/001 | ||||||||||
Product Form: | con inf 2x7,5 ml/450 mg (liek.inj.skl.) | ||||||||||
MA Status: | Ex - Conditional centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Boehringer Ingelheim International GmbH, Germany | ||||||||||
Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
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: | 09.12.2022 |
Validity: | 12.12.2025 |
SmPC + PL: |
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Safety feature | Yes |
Data update: | 20.11.2024 |