Tyenne 20 mg/mL concentrate for solution for infusion
*Company:
Fresenius Kabi LtdStatus:
UpdatedLegal 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
Updated on 13 January 2026
File name
IE-PIL-Tyenne Vial.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - what the product looks like and pack contents
Free text change information supplied by the pharmaceutical company
Update to the PIL
Updated on 13 January 2026
File name
IE-SmPC-Tyenne-Vial-v003.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.1 - List of excipients
- 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)
Free text change information supplied by the pharmaceutical company
Update to the SPC
Updated on 07 August 2025
File name
IE-SmPC-Tyenne-Vial-v002.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 6.3: change to shelf life for diluted medicinal product.
Section 10: change to availability of information.
Updated on 29 July 2025
File name
IE-PL-Tyenne-PFP-no-blister_clean.pdf
Reasons for updating
- Change to section 7 - Instructions for use
Free text change information supplied by the pharmaceutical company
Updated PIL
Updated on 29 July 2025
File name
IE-SmPC-Tyenne-Vial-v002.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
SPC Updated
Updated on 28 July 2025
File name
IE-SmPC-Tyenne-Vial-v002.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
SPC Update
File name
Tyenne Dosing Guide IRELAND 2024 Update.pdf
Reasons for updating
- Replace File
File name
Tyenne Patient Brochure IRELAND (1).pdf
Reasons for updating
- Replace File
File name
Tyenne Patient Alert Card IRELAND COMPACT.pdf
Reasons for updating
- Replace File
File name
Tyenne Healthcare Professional Brochure IRELAND (2).pdf
Reasons for updating
- Add New Doc
File name
Tyenne Dosing Guide IRELAND.pdf
Reasons for updating
- Add New Doc
File name
Tyenne Patient Brochure IRELAND (1).pdf
Reasons for updating
- Add New Doc
File name
Tyenne Patient Alert Card IRELAND COMPACT.pdf
Reasons for updating
- Add New Doc
Updated on 01 November 2023
File name
IE-SmPC-tyenne-Vial-v001.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 November 2023
File name
PIL Vial.pdf
Reasons for updating
- New PIL for new product
Fresenius Kabi Ltd
Address:
Unit 3B Fingal Bay Business Park, Balbriggan, Co. Dublin, Ireland, K32YK12Medical Information E-mail:
Medical.Information-uk@fresenius-kabi.com , jeremy.morais@fresenius-kabi.comTelephone:
+353 01 8413030 0Website:
www.fresenius-kabi.com/ieMedical Information Facsimile:
+ 353 1 849 6949Medical Information Direct Line:
+ 353 1 841 3030 , +44 1928 533575Stock Availability:
FK-enquiries.Ireland@fresenius-kabi.com