Wilate powder and solvent for solution for injection *
Pharmacy Only: Prescription

  • Company:

    Octapharma Ltd
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • *Additional information is available within the SPC or upon request to the company

Updated on 08 April 2021

File name

Wilate IE PIL 20201202_1617895395.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents

Updated on 08 April 2021

File name

Wilate IE SPC 20201202_1617894858.pdf

Reasons for updating

  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 30 April 2020

File name

Wilate IE PIL - 20200128 - Apr 2020_1588255666.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 30 April 2020

File name

Wilate IE SPC - 20200415 - Apr 2020_1588255543.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.5 - Nature and contents of container
  • 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 20 December 2019

File name

Wilate IE PIL - 20190522 - Dec 2019_1576857820.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to information for healthcare professionals

Updated on 20 December 2019

File name

Wilate IE SPC - 20191219 - Dec 2019_1576857626.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 15 August 2018

File name

Wilate IE SPC - June 2018_1534333147.pdf

Reasons for updating

  • File format updated to PDF

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 26 June 2018

File name

Wilate IE SPC - June 2018.docx

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • 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 26 June 2018

File name

Wilate IE PIL - June 2018.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
  • Change to further information section

Updated on 02 March 2016

File name

PIL_16653_535.pdf

Reasons for updating

  • New PIL for new product

Updated on 13 July 2015

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 13 July 2015

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • Change to section 9 - Date of renewal of authorisation
  • 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

Section6.4: Change the reconstituted shelf life from 12 hours to 4 hours$0Updated Licence renewal date and date of revision of text$0

Updated on 21 April 2015

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided