Zejula 100 mg hard capsules
*Company:
GlaxoSmithKline (Ireland) LtdStatus:
No Recent UpdateLegal 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 January 2024
File name
ie-pil-zejula-capsules-issue12draft1-clean-no headers.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 09 November 2023
File name
ie-spc-zejula-capsules-issue13draft1-clean - no headers.pdf
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Minor formatting throughout SPC
Updated on 06 June 2023
File name
ie-spc-zejula-capsules-issue12draft1-clean-no headers.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 January 2023
File name
ie-spc-zejula-capsules-issue11draft1-clean no headers.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
section 4.4: further data on Myelodysplastic syndrome/acute myeloid leukaemia via the NOVa study.
Section 4,4 and Section 4.6 : pregnancy - clarity on 'highly effective' contraception
Section 4.8: Addition of common AE - Myelodysplastic syndrome/ acute myeloid leukaemia
Section 5.1: further clarity on PARP inhibitor type: PARPi; inclusion of PFS for PRIMA study; inclusion of NOVa study endpoints
Updated on 05 January 2023
File name
ie-pil-zejula-capsules-issue11draft1-clean no headers.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
section 1 - administrative amendment to add more clarity to what Zejula is used for.
section 2 - pregnancy; change to wording from 'reliable' to 'highly effective' contraception
section 4 - addition of Low blood cell count as Common adverse event
Updated on 25 July 2022
File name
ie-pil-zejula-capsules-issue10-draft1-no header.pdf
Reasons for updating
- Change to section 6 - date of revision
- Removal of Black Inverted Triangle
Free text change information supplied by the pharmaceutical company
Removal of Black Triangle
Administrative updates but no new data
Updated on 25 July 2022
File name
ie-spc-zejula-capsules-issue10-draft-no headers.pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Removal of Black Inverted Triangle
- Change to improve clarity and readability
- Updated inline with QRD template and/or excipient guideline
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Removal of Black Triangle
Administrative updates to following sections but no addition of new data:
Section 2, 4.2, 4.4, 4.8, 5.1,
Updated on 20 June 2022
File name
ie-pil-issue8draft1-clean no headers.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to date of revision
Free text change information supplied by the pharmaceutical company
Section 2 -aligned to QRD format under Lactose heading
Section 5 - aligned to QRD format
Section 6: addition of statement ' not all pack sizes may be marketed'
Updated on 20 June 2022
File name
ie-spc-issue9draft1-clean no headers.pdf
Reasons for updating
- Change to section 5.2 - Pharmacokinetic properties
- Updated inline with QRD template and/or excipient guideline
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.4 - change in lactose section to include ‘total lactase deficiency’
Section 5.1 -table 5 reformatted but no new data
Section 5.2 - Inclusion of tablet formulations data
Updated on 18 August 2021
File name
ie-pil-issue8draft1-clean medicines.ie.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 18 August 2021
File name
ie-spc-issue8draft1-clean medicines.ie.pdf
Reasons for updating
- 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 27 July 2021
File name
ie-spc-issue7draft1-clean medicines.ie.pdf
Reasons for updating
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- 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
Sec 4.7 - addition that patients may experience difficulties concentrating
Sec 4.8 - addition of ADRs - cognitive impairment as a common side effect
Updated on 27 July 2021
File name
ie-pil-issue7draft1-clean medicines.ie.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Sec 4 - addition of ADRs - cognitive impairment as a common side effect
Updated on 28 June 2021
File name
ie-pil-issue6draft1-clean medicines.ie.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Hepatic impairment update
Remove batch sites
Updated on 28 June 2021
File name
ie-spc-issue6draft1-clean medicines.ie.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
Hepatic impairment warning
Updated on 01 March 2021
File name
ie-pil-zejula-issue5draft1-medicine.ie.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
New launch
Updated on 01 March 2021
File name
ie-spc-zejula-issue5 clean medicines.ie.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
New Launch