Code | 5167D | ||||||||||
MA number | 07/0168/20-S | ||||||||||
Product Form: | sol inf 10x100 ml/1000 mg (fľ.PP) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Mutual recognition procedure | ||||||||||
MAH, country: | Noridem Enterprises Ltd., Cyprus | ||||||||||
Therapeutic Class: | 07 - ANALGETICA, ANTIPYRETICA | ||||||||||
ATC: |
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Shelf life: | 24 | ||||||||||
Container: | bottle PP | ||||||||||
Route of admin.: | Intravenous use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 03.09.2020 |
Validity: | 03.09.2025 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
PIL: | PIL_Paracetamol Noridem 10 mg/ml infúzny roztok_07/2020_reg.docx |
SPC: | SPC_Paracetamol Noridem 10 mg/ml infúzny roztok_03.2021.pdf |
Safety feature | Yes |
Data update: | 07.09.2020 |