Product class:
|
Medicinal product with marketing authorization
|
Medicinal product class:
|
Human medicine
|
Name of medicinal product:
|
ABIRATERONE KRKA
|
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):
|
|
Package information leaflet (PIL):
|
EST
|
Labelling:
|
|
Indication:
|
Abiraterone Krka 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 docetaxelbased chemotherapy regimen.
|
Safety features:
|
Yes
|
Marketing authorization holder:
|
KRKA d.d. Novo mesto
|
Marketing authorization number:
|
EU/1/21/1553
|
Marketing authorization issued on:
|
June 24, 2021
|
Marketing authorization expires on:
|
June 28, 2026
|
Marketing authorization procedure type:
|
Centralised
|
Assessment report:
|
|
Package code
|
Name of medicinal product
|
Dosage form
|
Package
|
Legal status
|
Reimbursements
|
Reference price
|
Last imported
|
PƤritolumaa
|
Additional information
|
1856101
|
ABIRATERONE KRKA
|
film-coated tablet
|
500mg 56TK
|
Prescription
|
|
|
|
|
|
1856112
|
ABIRATERONE KRKA
|
film-coated tablet
|
500mg 60TK
|
Prescription
|
|
|
|
|
|
1856123
|
ABIRATERONE KRKA
|
film-coated tablet
|
500mg 56TK
|
Prescription
|
|
|
|
|
taskublister
|
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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