| Code | 9853D | ||||||||||
| MA number | 19/0053/22-S | ||||||||||
| Product Form: | sol ijf 5x5 ml (amp.skl.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | LEO Pharma A/S , Denmark | ||||||||||
| Therapeutic Class: | 19 - ANTIDOTA, DETOXICANTIA | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | glass ampoule | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10a well-established use application |
| MA issued: | 08.04.2022 |
| Validity: | 08.04.2027 |
| PIL: |
PIL_Protamine sulfate LEO Pharma 1400 anti-heparin IUml_03 2022.pdf
|
| SPC: |
SPC_Protamine sulfate LEO Pharma 1400 anti-heparin IUml_03 2022.pdf
|
| Safety feature | Yes |
| Data update: | 12.04.2022 |
