Integrilin 0.75 mg/ml solution for infusion *

  • Company:

    GlaxoSmithKline (Ireland) Ltd
  • Status:

    No Recent Update
  • Legal 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

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 09 March 2021

File name

ie-pil-integrilin0.75mg-issue5draft1-medicines.ie_1615324875.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Free text change information supplied by the pharmaceutical company

Remove non-active batch release site

Updated on 11 September 2020

File name

ie-spc-integrilin0.75mg-issue3draft1-med.ie_1599838897.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use

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

Free text change information supplied by the pharmaceutical company

update to include sodium excipients warning

Updated on 11 September 2020

File name

ie-pil-integrilin0.75mg-issue4draft1-med.ie_1599838834.pdf

Reasons for updating

  • Change to section 2 - excipient warnings

Free text change information supplied by the pharmaceutical company

additon of sodium excipients warning

Updated on 05 April 2019

File name

ie-pil-integrilin0.75issue3draft clean Med ie_1554457318.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 16 November 2018

File name

ie-pil-integrilin0.75issue2draft1-clean_1542372573.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 16 November 2018

File name

ie-spc-integrilin0.75issue2draft1-clean_1542372666.pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

Section 4.8: removal of UK reporting information

Section 7 updated: MAH transfer

Updated on 28 April 2017

File name

PIL_15494_913.pdf

Reasons for updating

  • New PIL for new product

Updated on 28 April 2017

Reasons for updating

  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 02 December 2015

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 19 June 2015

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

2. QUALITATIVE AND QUANTITATIVE COMPOSITION – QRD update
4.6 Fertility, pregnancy and lactation – administrative update
4.8 Undesirable effects – spelling corrections and QRD updates including reporting details

Updated on 19 June 2015

Reasons for updating

  • New SPC for new product

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

Updated on 18 June 2015

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 13 August 2014

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to MA holder contact details

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

Free text change information supplied by the pharmaceutical company

Section 7 - MAH Address changes from Greenford to Brentford

Updated on 12 August 2014

Reasons for updating

  • Change to date of revision
  • Addition of marketing authorisation holder

Updated on 18 September 2012

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

Updated on 14 September 2012

Reasons for updating

  • New PIL for medicines.ie