Zejula 100 mg film-coated tablets
*Company:
GlaxoSmithKline (Ireland) LtdStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 12 June 2026
File name
ie-pil-zejula-tablets-issue12-draft1-clean-master.pdf
Reasons for updating
- Change to section 2 - use in children and adolescents
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
- Change to section 2 - use in children and adolescents
- Change to section 6 - date of revision
Updated on 11 June 2026
File name
ie-spc-zejula-tablets-issue12draft1-clean-master.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
SPC Updates
4.2 – update to study results in Paediatric population
4.8 – Deletion of statement ‘No studies have been conducted in paediatric patients’
5.1 - update to study results in Paediatric population
5.2 - inclusion of study results in Paediatric population
10 – Revision date
Updated on 11 June 2026
File name
ie-pil-zejula-tablets-issue12-draft1-clean-master.pdf
Reasons for updating
- Change to section 2 - use in children and adolescents
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
PIL Updates:
Section 2 – update statement for use of medicine in children and adolescents
Section 6 - Update to manufacturer address
Section 6 - Revision date
Updated on 21 November 2025
File name
ie-spc-zejula-tablets-issue11draft1-Master.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Change to section 7 - Marketing authorisation holder: GlaxoSmithKline (Ireland) Limited to GlaxoSmithKline Trading Services Limited and addition of postcode
Change to section 10 - Date of revision of text
Updated on 21 November 2025
File name
ie-pl-zejula-tablets-issue11-draft1-Master.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Change to section 6 - marketing authorisation holder: GlaxoSmithKline (Ireland) Limited to GlaxoSmithKline Trading Services Limited and addition of postcode
Change to section 6 - date of revision
Update to local representative information
Updated on 30 June 2025
File name
ie-spc-zejula-tablets-issue10draft1-Master.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 30 June 2025
File name
ie-pil-zejula-tablets-issue10draft1-Master.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
- Change to further information section
Updated on 04 April 2025
File name
ie-spc-zejula-tablets-issue9draft1.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 04 April 2025
File name
ie-pil-zejula-tablets-issue9-draft1.pdf
Reasons for updating
- Change to other sources of information section
Updated on 15 January 2024
File name
ie-spc-zejula-tablets-issue8draft1-clean-no headers.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 15 January 2024
File name
ie-ukni-pil-zejula-tablets-issue8-draft1-clean-no headers.pdf
Reasons for updating
- New PIL for new product
GlaxoSmithKline (Ireland) Ltd
Address:
12 Riverwalk, Citywest Business Campus, Dublin 24, IrelandTelephone:
+353 1 495 5000Medical Information Direct Line:
1 800 244 255