| Code | 1831D | ||||||||||
| MA number | 76/0169/19-S | ||||||||||
| Product Form: | sol inf 10x1000 ml (vak POF/PA) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| Therapeutic Class: | 76 - INFUNDIBILIA | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | bag POF/PA (polyolefin/polyamide) | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10a well-established use application |
| MA issued: | 20.06.2019 |
| Validity: | 20.06.2024 |
| MA renewed: | Renewal application submitted |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_GNAK 50 mg-ml infúzny roztok_06.2020.docx
|
| SPC: |
SPC_GNAK 50 mg-ml infúzny roztok_06.2020.docx
|
| Safety feature | No |
| Data update: | 08.07.2019 |
