LYNPARZA Hard capsule Ref.[8402] Active ingredients: Olaparib

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: AstraZeneca AB, SE-151 85 Södertälje, Sweden

Product name and form

Lynparza 50 mg hard capsules.

Pharmaceutical Form

Hard capsule.

White, opaque, size 0 hard capsule, marked with “OLAPARIB 50 mg” and the AstraZeneca logo in black ink.

Qualitative and quantitative composition

Each hard capsule contains 50 mg of olaparib.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Olaparib

Olaparib is a potent inhibitor of human poly (ADP-ribose) polymerase enzymes (PARP-1, PARP-2, and PARP-3), and has been shown to inhibit the growth of selected tumour cell lines in vitro and tumour growth in vivo either as a standalone treatment or in combination with established chemotherapies or new hormonal agents (NHA).

List of Excipients

Capsule content:

Lauroyl macrogol-32 glycerides

Capsule shell:

Hypromellose
Titanium dioxide (E171)
Gellan gum (E418)
Potassium acetate

Printing ink:

Shellac
Iron oxide black (E172)

Pack sizes and marketing

HDPE plastic bottle with a child-resistant closure containing 112 hard capsules.

Pack of 448 capsules (4 bottles of 112 capsules).

Marketing authorization holder

AstraZeneca AB, SE-151 85 Södertälje, Sweden

Marketing authorization dates and numbers

EU/1/14/959/001

Date of first authorisation: 16 December 2014

Drugs

Drug Countries
LYNPARZA Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States

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