| 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 |
