Code | 03514 | ||||||||||
MA number | 68/0012/76-S | ||||||||||
Product Form: | sol inj 5x1 ml/25 mg (amp.skl.hnedá) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | National | ||||||||||
MAH, country: | BB Pharma a.s., Czechia | ||||||||||
Therapeutic Class: | 68 - ANTIPSYCHOTICA (NEUROLEPTICA) | ||||||||||
ATC: |
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Shelf life: | 24 | ||||||||||
Container: | brown glass ampoule | ||||||||||
Route of admin.: | Intramuscular or intravenous use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10a well-established use application |
MA issued: | 30.12.1976 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric contraindication: | Yes |
SPC: | SPC_AFLUDITEN_11.2018.doc.doc |
PIL: | PIL_AFLUDITEN_11.2018.doc.doc |
Safety feature | Yes |
Data update: | 22.01.2018 |