| Code | 7808E | ||||||||||
| MA number | 78/0281/24-S | ||||||||||
| Product Form: | sol inj 5x5 ml/50 mg (amp.skl.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Fresenius Kabi s.r.o., Czechia | ||||||||||
| Therapeutic Class: | 78 - SYMPATHOMIMETICA | ||||||||||
| 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 10(3) hybrid application |
| MA issued: | 30.10.2024 |
| Validity: | 30.10.2029 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| PIL: |
PIL_Ephedrine Kabi_10 mg_ml_12_2025.pdf
|
| SPC: |
SPC_Ephedrine Kabi_10 mg_ml_12_2025.pdf
|
| Safety feature | Yes |
| Data update: | 10.12.2025 |
