| Code | 5425D | ||||||||||
| MA number | 07/0193/20-S | ||||||||||
| Product Form: | sol inf 10x100 ml (liek.inj.skl) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | MEDOCHEMIE Ltd., Cyprus | ||||||||||
| Therapeutic Class: | 07 - ANALGETICA, ANTIPYRETICA | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - known active substance |
| MA issued: | 03.09.2020 |
| Pediatric contraindication: | Yes |
| SPC: |
SPC_Elomen_06.2023.pdf
|
| PIL: |
PIL_Elomen_07.2024.pdf
|
| Safety feature | Yes |
| Data update: | 10.03.2025 |
