LYNPARZA

Χώρα: Ινδονησία

Γλώσσα: Ινδονησιακά

Πηγή: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Δραστική ουσία:

OLAPARIB

Διαθέσιμο από:

ASTRAZENECA INDONESIA - Indonesia

INN (Διεθνής Όνομα):

OLAPARIB

Δοσολογία:

150 Mg

Φαρμακοτεχνική μορφή:

TABLET SALUT SELAPUT

Μονάδες σε πακέτο:

DUS, 7 BLISTER @ 8 TABLET SALUT SELAPUT

Κατασκευάζεται από:

ABBVIE LIMITED - United States of America

Ημερομηνία της άδειας:

2021-02-22

Αρχείο Π.Χ.Π.

PROPOSED PACKAGING MATERIAL
Code
LYNPARZA 100 150 (56s) TAB-PI-03.01
Submission
☐
NDA
☐
Renewal
☑
Variation change detail no.: MU-104953-135498_ _
Code of previous version
LYNPARZA 100 150 (56s) TAB-PI-01.02
Changes
Additional Indication of PROfound
Reference
☑
CDS version: V3.0 / Doc ID-004025980
☐
CPIL version:
☑
SmPC country/version/date: EU SmPC/ Feb 2021/
Doc ID-004086888 v11.
☐
GRL approval: 24 May 2021
Name & Date
MMN – 6 Jun 2022
DISETUJUI OLEH BPOM: 19/10/2022
EREG10042212200028
EREG10042212200029
LYNPARZA™
_Olaparib _
FILM-COATED TABLET
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
Lynparza 100 mg film-coated tablets
Each film-coated tablet contains 100 mg olaparib.
Lynparza 150 mg film-coated tablets
Each film-coated tablet contains 150 mg olaparib.
Excipient with known effect:
This medicinal product contains 0.24 mg sodium per 100 mg tablet and
0.35 mg sodium per
150 mg tablet, i.e. essentially “sodium-free”.
For excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Lynparza 100 mg film-coated tablets
Yellow to dark yellow, oval, bi-convex tablet, debossed with
‘OP100’ on one side and plain
on the other side.
Lynparza 150 mg film-coated tablets
Green to green/grey, oval, bi-convex tablet, debossed with ‘OP150’
on one side and plain on
the other side.
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