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PRODUCT DETAIL

Ondexxya 200 mg prášok na infúzny roztok

Code 1404D
MA number EU/1/18/1345/001
Product Form: plv ifo 4x200 mg (liek.inj.skl.)
MA Status: Ex - Conditional centralised marketing authorisation
Type of procedure: EU
Therapeutic Class: 19 - ANTIDOTA, DETOXICANTIA
ATC:
V VARIOUS
V03 ALL OTHER THERAPEUTIC PRODUCTS
V03A ALL OTHER THERAPEUTIC PRODUCTS
V03AB Antidotes
V03AB38 Andexanet alfa
Shelf life: 36
Container: glass vial
Route of admin.: Intravenous use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 26.04.2019
Validity: 30.04.2023
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 15.05.2022
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