Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: AstraZeneca AB, SE-151 85 Södertälje, Sweden
Lynparza 100 mg film-coated tablets.
Lynparza 150 mg film-coated tablets.
| 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. |
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.
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 |
|---|
|
Tablet core: Copovidone Tablet coating: Hypromellose |
Alu/Alu non-perforated blister containing 8 film-coated tablets.
Pack sizes:
56 film-coated tablets (7 blisters).
Multipack containing 112 (2 packs of 56) film-coated tablets.
Not all pack sizes may be marketed.
AstraZeneca AB, SE-151 85 Södertälje, Sweden
EU/1/14/959/002 56 film-coated tablets (100 mg)
EU/1/14/959/003 112 film-coated tablets (2 packs of 56) (100 mg)
EU/1/14/959/004 56 film-coated tablets (150 mg)
EU/1/14/959/005 112 film-coated tablets (2 packs of 56) (150 mg)
Date of first authorisation: 16 December 2014
Date of latest renewal: 1 October 2019
| 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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