Code | 53547 | ||||||||||
MA number | 19/0540/08-S | ||||||||||
Product Form: | sol ifc 10x10 ml/1 mg | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Pharmaselect International Beteiligungs GmbH, Austria | ||||||||||
Therapeutic Class: | 19 - ANTIDOTA, DETOXICANTIA | ||||||||||
ATC: |
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Shelf life: | 48 | ||||||||||
Container: | glass ampoule | ||||||||||
Route of admin.: | Intravenous use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 15.10.2008 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
PIL: | PIL_Flumazenil Pharmaselect 0,1 mg_ml_sol ifc_09_2017.doc |
SPC: | SPC_Flumazenil Pharmaselect 0,1 mg_ml_sol ifc_11_2023.pdf |
Safety feature | Yes |
Data update: | 04.07.2024 |