Zejula 100 mg hard capsules *
Pharmacy Only: Prescription

  • Company:

    GlaxoSmithKline (Ireland) Ltd
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    This medicinal product is subject to additional monitoring.

    *Additional information is available within the SPC or upon request to the company

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

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