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ABIRATERONE STADA
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1881468
Name of medicinal product:
ABIRATERONE STADA
Active substances:
Abiraterone
Estonian
,
English
,
Latin
ATC code:
L02BX03
Dosage form:
film-coated tablet
Route of administration:
oral use
Strengh:
500mg
Amount in package:
10TK
Legal status for supply*:
Subject to medicinal prescription
Class of active substance:
Additional information:
üksikannuseline blister
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 May 11, 2023)
Package information leaflet (PIL):
EST
(last updated December 22, 2022)
Labelling:
(last updated August 22, 2022)
Last imported to Estonia:
Never imported to Estonia
Marketing authorization
Marketing authorization holder:
Stada Arzneimittel AG
Marketing authorization number:
1068622
Marketing authorization issued on:
August 22, 2022
Marketing authorization expires on:
August 22, 2027
Marketing authorization procedure type:
Mutual recognition
Prices
Reference price:
Under reference price:
Reference price of daily dose:
Entry/Changing date: November 15, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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