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ABIRATERONE TEVA
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1880591
Name of medicinal product:
ABIRATERONE TEVA
Active substances:
Abiraterone
Estonian
,
English
,
Latin
ATC code:
L02BX03
Dosage form:
film-coated tablet
Route of administration:
oral use
Strengh:
500mg
Amount in package:
120TK
Legal status for supply*:
Subject to medicinal prescription
Class of active substance:
Additional information:
üksikannuseline blister
Indication:
[Product name] 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 February 14, 2024)
Package information leaflet (PIL):
EST
(last updated February 14, 2024)
Labelling:
(last updated February 14, 2024)
Last imported to Estonia:
Never imported to Estonia
Marketing authorization
Marketing authorization holder:
Teva B.V.
Marketing authorization number:
1065522
Marketing authorization issued on:
June 30, 2022
Marketing authorization expires on:
June 30, 2027
Marketing authorization procedure type:
Decentralised
Prices
Reference price:
Under reference price:
Reference price of daily dose:
Entry/Changing date: February 14, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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