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PRODUCT DETAIL

Protamine sulfate LEO Pharma 1400 anti-heparin IU/ml

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
Therapeutic Class: 19 - ANTIDOTA, DETOXICANTIA
ATC:
V VARIOUS
V03 ALL OTHER THERAPEUTIC PRODUCTS
V03A ALL OTHER THERAPEUTIC PRODUCTS
V03AB Antidotes
V03AB14 Protamine
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
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