Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Zejula 100 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule (capsule). Hard capsule of approximately 22 mm × 8 mm; white body with “100 mg” printed in black ink and purple cap with “Niraparib” printed in white ink. |
Each hard capsule contains niraparib tosylate monohydrate equivalent to 100 mg niraparib.
Excipients with known effect:
Each hard capsule contains 254.5 mg of lactose monohydrate (see section 4.4).
Each hard capsule shell also contains 0.0172 mg of the colouring agent tartrazine (E102).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Niraparib |
Niraparib is an inhibitor of poly(ADP-ribose) polymerase (PARP) enzymes, PARP-1 and PARP-2, which play a role in DNA repair. |
| List of Excipients |
|---|
|
Capsule content: Magnesium stearate Capsule shell: Titanium dioxide (E171) Printing ink: Shellac (E904) |
Aclar/PVC/aluminium foil perforated unit dose blisters in cartons of 84 × 1, 56 × 1 and 28 × 1 hard capsules.
Not all pack sizes may be marketed.
GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
EU/1/17/1235/001
EU/1/17/1235/002
EU/1/17/1235/003
Date of first authorisation: 16 November 2017
Date of latest renewal: 18 July 2022
| Drug | Countries | |
|---|---|---|
| ZEJULA | Austria, Brazil, Canada, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Turkey, United Kingdom, United States |
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