Code | 5749C | ||||||||||
MA number | 19/0339/17-S | ||||||||||
Product Form: | sol ijf 5x1 ml/0,4 mg (amp.skl.) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | MEDOCHEMIE Ltd., Cyprus | ||||||||||
Therapeutic Class: | 19 - ANTIDOTA, DETOXICANTIA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | glass ampoule | ||||||||||
Route of admin.: | Intramuscular or intravenous use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 14.11.2017 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
PIL: | PIL_FORVEL 0,4 mg/ml_sol ijf_11/2017_REG.docx |
SPC: | SPC_FORVEL 0,4 mg/ml_sol ijf_11/2017_REG.docx |
Safety feature | Yes |
Data update: | 17.03.2023 |