LYNPARZA FILM-COATED TABLET 100MG

Krajina: Singapur

Jazyk: angličtina

Zdroj: HSA (Health Sciences Authority)

Aktívna zložka:

Olaparib

Dostupné z:

ASTRAZENECA SINGAPORE PTE LTD

ATC kód:

L01XK01

Forma lieku:

TABLET, FILM COATED

Zloženie:

Olaparib 100mg

Spôsob podávania:

ORAL

Typ predpisu:

Prescription Only

Výrobca:

AbbVie Deutschland GmbH & Co. KG

Stav Autorizácia:

ACTIVE

Dátum Autorizácia:

2019-04-09

Súhrn charakteristických

LYNPARZA
®
(OLAPARIB)
1.
NAME OF THE MEDICINAL PRODUCT
Lynparza (olaparib), 150 mg, film-coated tablets
Lynparza (olaparib), 100 mg, film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 150 mg film-coated tablet contains 150 mg of olaparib.
Each 100 mg film-coated tablet contains 100 mg of olaparib.
For excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
The Lynparza 150 mg tablet is a green to green/grey, oval, bi-convex
tablet debossed with
‘OP150’ on one side and plain on the reverse.
The Lynparza 100 mg tablet is a yellow to dark yellow, oval, bi-convex
tablet debossed with
‘OP100’ on one side and plain on the reverse.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
OVARIAN CANCER
Lynparza is indicated as monotherapy for the:
•
maintenance treatment
of adult patients with
advanced (FIGO stages
III
and
IV)
_BRCA1/2_
-mutated (germline and/or somatic) high-grade epithelial ovarian,
fallopian tube
or primary peritoneal cancer who are in response (complete or partial)
following
completion of first-line platinum-based chemotherapy.
•
maintenance treatment of adult patients with platinum-sensitive
relapsed high-grade
epithelial ovarian, fallopian tube or primary peritoneal cancer who
are in response
(complete response or partial response) to platinum-based
chemotherapy.
Lynparza in combination with bevacizumab is indicated for the:
•
maintenance treatment of adult patients with advanced (FIGO stages III
and IV) high-
grade epithelial ovarian, fallopian tube or primary peritoneal cancer
who are in response
(complete response or partial response) following completion of
first-line platinum-based
chemotherapy in combination with bevacizumab
and whose cancer is associated with
homologous recombination deficiency (HRD) positive status defined by
either a
_BRCA_
1/2
mutation and/or genomic instability (see section 5.1).
BREAST CANCER
Lynparza is indicated:
•
for the adjuvant treatment of adult patients with germline
_BRCA_
-mutated HER2-negative
high risk early br