Integrilin 2 mg/ml solution for injection
*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 23 March 2023
File name
ieukni-pl-combined-integrilin2mg-issue6draft1 (3).pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to further information section
Free text change information supplied by the pharmaceutical company
Article 61(3) Notification to update the local representative section of the PIL (section 6). Reporting details updated for UK- Northern Ireland.
Updated on 09 March 2021
File name
ie-pil-integrilin2mg-issue5draft1-medicines.ie.pdf
Reasons for updating
- Change to section 6 - manufacturer
Free text change information supplied by the pharmaceutical company
Remove inactive batch release site
Updated on 11 September 2020
File name
ie-spc-integrilin2mg-issue3draft1-med.ie.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
addition of sodium excipients warning
Updated on 11 September 2020
File name
ie-pil-integrilin2mg-issue4draft1-med.ie.pdf
Reasons for updating
- Change to section 2 - excipient warnings
Free text change information supplied by the pharmaceutical company
update to include sodium excipients warning
Updated on 19 November 2019
File name
ie-pil-integrilin0.75issue3draft clean Med ie.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 16 November 2018
File name
ie-pil-integrilin2mgissue11draft1-clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 16 November 2018
File name
ie-spc-integrilin2mgissue2draft1-clean.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_15758_648.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
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 19 June 2015
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- 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
4.2 Posology and method of administration – Administrative update
4.6 Fertility, pregnancy and lactation – administrative update
4.8 Undesirable effects – spelling corrections and QRD updates including reporting details
Updated on 18 June 2015
Reasons for updating
- Addition of information on reporting a side effect.
Updated on 12 August 2014
Reasons for updating
- Change to date of revision
- Addition of marketing authorisation holder
Updated on 11 June 2013
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
Updated on 11 June 2013
Reasons for updating
- New PIL for new product