Code | 5425D | ||||||||||
MA number | 07/0193/20-S | ||||||||||
Product Form: | sol inf 10x100 ml (liek.inj.skl) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
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 |
Validity: | 03.09.2025 |
MA renewed: | Renewal application submitted |
Pediatric contraindication: | Yes |
SPC: | SPC_Elomen_06.2023.pdf |
PIL: | PIL_Elomen_07.2024.pdf |
Safety feature | Yes |
Data update: | 26.06.2023 |