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PRODUCT DETAIL

Orgovyx 120 mg filmom obalené tablety

Code 0658E
MA number EU/1/22/1642/001
Product Form: tbl flm 30x120 mg (fľ.HDPE)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
MAH, country: Accord Healthcare S.L.U, Spain
Therapeutic Class: 44 - CYTOSTATICA
ATC:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L02 ENDOCRINE THERAPY
L02B HORMONE ANTAGONISTS AND RELATED AGENTS
L02BX Other hormone antagonists and relate agents
L02BX04 Relugolix
Shelf life: 36
Container: bottle HDPE
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: 29.04.2022
Validity: 29.04.2027
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 15.12.2022
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