Zejula 100 mg hard capsules *
Pharmacy Only: Prescription

Updated on 25 July 2022

File name

62dea079e6bf5.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

62de9fa76553b.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

62b050153a1a8.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

62b04f3cd0817.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_1629274962.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_1629274894.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_1627377626.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_1627377564.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_1624914123.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_1624914056.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_1614585268.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_1614585219.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