Tyenne 162 mg solution for injection in pre-filled syringe
*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 22 September 2026
File name
IE-PIL-Tyenne PFS-V004-clean.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 7 - Instructions for use
Free text change information supplied by the pharmaceutical company
Updated PIL
Updated on 22 September 2026
File name
IE-SmPC-Tyenne PFS-v003-clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.4 - Special precautions for storage
- 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)
Free text change information supplied by the pharmaceutical company
Updated SPC
Updated on 13 January 2026
File name
IE-PIL-Tyenne PFS.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product looks like and pack contents
- Change to section 7 - Instructions for use
Free text change information supplied by the pharmaceutical company
Update to the PIL
Updated on 13 January 2026
File name
IE-SmPC-Tyenne PFS-v002.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.1 - List of excipients
- Change to section 6.4 - Special precautions for storage
- 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
File name
Tyenne Dosing Guide IRELAND 2024 Update.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Update to dosing tables with correct colours of vials.
Updated on 10 February 2025
File name
PPM-PH-0030064-2024-Sep-Tyenne-PFS-PIL-IE (1).pdf
Reasons for updating
- New PIL for new product
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 Dosing Guide IRELAND.pdf
Reasons for updating
- Add New Doc
File name
Tyenne Healthcare Professional Brochure IRELAND (2).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 PFS-v001.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
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