ZEJULA Hard capsule Ref.[7611] Active ingredients: Niraparib

Source: European Medicines Agency (EU)  Revision Year: 2023  Publisher: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Product name and form

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.

Qualitative and quantitative composition

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
Lactose monohydrate

Capsule shell:

Titanium dioxide (E171)
Gelatin
Brilliant blue FCF (E133)
Erythrosine (E127)
Tartrazine (E102)

Printing ink:

Shellac (E904)
Propylene glycol (E1520)
Potassium hydroxide (E525)
Black iron oxide (E172)
Sodium hydroxide (E524)
Povidone (E1201)
Titanium dioxide (E171)

Pack sizes and marketing

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.

Marketing authorization holder

GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Marketing authorization dates and numbers

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

Drugs

Drug Countries
ZEJULA Austria, Brazil, Canada, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Turkey, United Kingdom, United States

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