| Code | 1098F | ||||||||||
| MA number | 07/0269/25-S | ||||||||||
| Product Form: | sol inf 1x100 ml (liek.inj.skl.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | AGmed s.r.o., Czechia | ||||||||||
| 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 10(1) generic application |
| MA issued: | 25.09.2025 |
| Validity: | 25.09.2030 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| PIL: |
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| SPC: |
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| Safety feature | Yes |
| Data update: | 26.09.2025 |