Product class:
|
Medicinal product with marketing authorization
|
Medicinal product class:
|
Human medicine
|
Name of medicinal product:
|
ABIRATERONE ZENTIVA
|
Active substances:
|
|
ATC code:
|
L02BX03
|
Dosage form:
|
film-coated tablet
|
Strength:
|
500mg
|
Legal status for supply*:
|
Subject to medicinal prescription
|
Summary of product characteristics (SPC):
|
(last updated March 12, 2024)
|
Package information leaflet (PIL):
|
EST (last updated November 30, 2021)
|
Labelling:
|
(last updated November 30, 2021)
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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
|
Marketing authorization holder:
|
Zentiva k.s.
|
Marketing authorization number:
|
1046921
|
Marketing authorization issued on:
|
November 30, 2021
|
Marketing authorization expires on:
|
November 30, 2026
|
Marketing authorization procedure type:
|
Decentralised
|
Assessment report:
|
|
Package code
|
Name of medicinal product
|
Dosage form
|
Package
|
Legal status
|
Reimbursements
|
Reference price
|
Last imported
|
PƤritolumaa
|
Additional information
|
1829987
|
ABIRATERONE ZENTIVA
|
film-coated tablet
|
500mg 56TK
|
Prescription
|
|
|
|
|
|
1829998
|
ABIRATERONE ZENTIVA
|
film-coated tablet
|
500mg 60TK
|
Prescription
|
100%
|
664,50
|
22.03.2024
|
|
|
1865145
|
ABIRATERONE ZENTIVA
|
film-coated tablet
|
500mg 120TK
|
Prescription
|
|
|
|
|
|
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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