Tisseel Ready to Use
*Company:
Baxter Holding B.V.Status:
UpdatedLegal 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 20 April 2026
File name
ie-pl-Jan2026-tisseel-rtu-clean.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
- Change to section 7 - Instructions for use
Updated on 20 April 2026
File name
ie-spc-Tisseel-RTU-PA2299-025-001-April 2026.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 6.1 - List of excipients
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- 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 07 August 2023
File name
ie-mockup-2022-01-pl-tisseel rtu -ast-2299025001-c.pdf
Reasons for updating
- New PIL for new product
Updated on 26 January 2023
File name
ie-spc-2020-07-tisseelrtu-2299025001-c.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 July 2020
File name
ie-spc-2020-07-tisseelrtu-2299025001-c.pdf
Reasons for updating
- Change to section 6.6 - Special precautions for disposal and other handling
- 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 10 March 2020
File name
ie-spc-2020-03-tisseelrtu-2299025001-c.pdf
Reasons for updating
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- 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 02 May 2019
File name
ie-spc-2019-03-tisseelrtu-2299025001-c.pdf
Reasons for updating
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 April 2019
File name
ie-spc-2019-03-tisseelrtu-2299025001-c.pdf
Reasons for updating
- 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 11 February 2019
File name
ie-spc-2019-01-tisseelrtu-0167129005-c.pdf
Reasons for updating
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 8 - Marketing authorisation number(s)
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- 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 01 September 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Baxter Holding B.V.
Address:
Kobaltweg 49, 3542CE Utrecht, NetherlandsMedical Information E-mail:
medinfo_uki@baxter.comTelephone:
+44 (0)1635 206 345Medical Information Facsimile:
+44 (0)1635 206071Medical Information Direct Line:
+44 (0)1635 206345