Code | 77585 | ||||||||
MA number | 80/0348/09-S | ||||||||
Product Form: | con inf 4x10 ml/250 mg (skl.amp.) | ||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||
Type of procedure: | Mutual recognition procedure | ||||||||
MAH, country: | Recordati Rare Diseases, France | ||||||||
Therapeutic Class: | 80 - HEPATICA | ||||||||
ATC: |
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Shelf life: | 36 | ||||||||
Container: | glass ampoule | ||||||||
Route of admin.: | Intravenous use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 8(3) application - known active substance |
MA issued: | 25.06.2009 |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
PIL: | PIL_NORMOSANG 25 mg_ml_12.2021.pdf |
SPC: | SPC_NORMOSANG 25 mg_ml_04_2024.pdf |
Safety feature | Yes |
Data update: | 25.04.2024 |