LYNPARZA TABLET

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

OLAPARIB

Dostupné z:

ASTRAZENECA CANADA INC

ATC kód:

L01XK01

INN (Medzinárodný Name):

OLAPARIB

Dávkovanie:

100MG

Forma lieku:

TABLET

Zloženie:

OLAPARIB 100MG

Spôsob podávania:

ORAL

Počet v balení:

60/120

Typ predpisu:

Prescription

Terapeutické oblasti:

ANTINEOPLASTIC AGENTS

Prehľad produktov:

Active ingredient group (AIG) number: 0158110002; AHFS:

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2018-05-04

Súhrn charakteristických

LYNPARZA
®
(olaparib tablets)
Page 1 of 97
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
LYNPARZA
®
Olaparib Tablets
Tablets, 100 mg and 150 mg, oral use
Antineoplastic agent
LYNPARZA (olaparib) indicated as:
•
_in combination with abiraterone and prednisone or prednisolone for
the treatment of adult patients _
_with deleterious or suspected deleterious germline and/or somatic
BRCA mutated metastatic _
_castration resistant prostate cancer (mCRPC) in whom chemotherapy is
not clinically indicated. _
_BRCA mutation must be confirmed before LYNPARZA treatment is
initiated. _
has been issued MARKETING AUTHORIZATION WITH CONDITIONS, pending the
results of trials to verify its
clinical benefit. Patients should be advised of the nature of the
authorization. For further information for
LYNPARZA, please refer to Health Canada’s Notice of Compliance with
conditions - drug products
website:
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/notice-
compliance/conditions.html
LYNPARZA indicated as monotherapy for the:
•
_Adjuvant treatment of adult patients with deleterious or suspected
deleterious germline BRCA-_
_mutated (BRCAm), human epidermal growth factor receptor 2
(HER2)-negative high risk early _
_breast cancer who have been treated with neoadjuvant or adjuvant
chemotherapy. Patients must _
_have confirmation of germline BRCA mutation before LYNPARZA treatment
is initiated. _
•
_Treatment of adult patients with deleterious or suspected deleterious
germline BRCA-mutated _
_(gBRCAm), HER2-negative metastatic breast cancer who have previously
been treated with _
_chemotherapy in the neoadjuvant, adjuvant or metastatic setting.
Patients with hormone receptor _
_(HR)-positive breast cancer should have progressed on or be
considered inappropriate for _
_endocrine therapy. Germline BRCA mutation must be confirmed before
LYNPARZA treatment is _
_initiated. _
•
_Maintenance treatment of adult patients with advanced BRCA-mutated
high-grade epithelial _
_ovarian, fallop