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PRODUCT DETAIL

Winrevair 60 mg prášok a rozpúšťadlo na injekčný roztok

Code 7331E
MA number EU/1/24/1850/003
Product Form: plv iol 1x60 mg + 1x1,3 ml solv. (liek.inj.skl.+striek.inj.napl.skl.)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU Orphan
MAH, country: Merck Sharp & Dohme B.V., Netherland
Therapeutic Class: 58 - HYPOTENSIVA
ATC:
C CARDIOVASCULAR SYSTEM
C02 ANTIHYPERTENSIVES
C02K OTHER ANTIHYPERTENSIVES
C02KX Antihypertensives for pulmonary arterial hypertension
C02KX06 Sotatercept
Shelf life: 36
Container: glass vial
Route of admin.: Subcutaneous use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 22.08.2024
Validity: 22.08.2029
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 04.09.2024
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