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PRODUCT DETAIL

Erleada 60 mg filmom obalené tablety

Code 0336D
MA number EU/1/18/1342/003
Product Form: tbl flm 120x60 mg (fľ.HDPE)
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
L02BB05 Apalutamide
Shelf life: 36
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: 14.01.2019
Validity: 14.01.2024
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 27.01.2022
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