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PRODUCT DETAIL

NUBEQA 300 mg filmom obalené tablety

Code 7529D
MA number EU/1/20/1432/002
Product Form: tbl flm 96x300 mg (blis.PVC/Al)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
Therapeutic Class: 44 - CYTOSTATICA
ATC:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L02 ENDOCRINE THERAPY
L02B HORMONE ANTAGONISTS AND RELATED AGENTS
L02BB Anti-androgens
L02BB06 Darolutamide
Shelf life: 36
Container: blister PVC/Al
Route of admin.: Oral use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 27.03.2020
Validity: 27.03.2025
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 12.05.2021
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