Register of Medicinal Products

ABIRATERONE SANDOZ

Product class:	Authorized package
Medicinal product class:	For human use
Package code:	1814701
Name of medicinal product:	ABIRATERONE SANDOZ
Active substances:	Abiraterone Estonian, English, Latin
ATC code:	L02BX03
Dosage form:	film-coated tablet
Route of administration:	oral use
Strengh:	1000mg
Amount in package:	28TK
Legal status for supply*:	Subject to medicinal prescription
Class of active substance:
Additional information:
Indication:	is indicated with prednisone or prednisolone for: • the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT) (see section 5.1) • the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1) • the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.
Safety features:	Yes
Summary of product characteristics (SPC):	(last updated July 6, 2021)
Package information leaflet (PIL):	EST (last updated July 6, 2021)
Labelling:	(last updated July 6, 2021)
Last imported to Estonia:	Never imported to Estonia

Marketing authorization

Marketing authorization holder:	Sandoz Pharmaceuticals d.d.
Marketing authorization number:	1034821
Marketing authorization issued on:	July 6, 2021
Marketing authorization expires on:	July 6, 2026
Marketing authorization procedure type:	Decentralised

Reference price:
Under reference price:
Reference price of daily dose:

Entry/Changing date: May 10, 2023

Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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