Tivicay 5mg dispersible tablets
*Company:
ViiV Healthcare BVStatus:
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 23 October 2025
File name
ie-pl-tivicay5mg-issue10draft1-clean-noheaders-paeds.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Section 4 Side effects (sideroblastic anaemia - frequency not unknown)
Section 6 (date updated)
Updated on 23 October 2025
File name
ie-spc-tivicay5mg-issue12draft1-clean-noheaders-paeds.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- 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 4.6 (sentence added regarding occurrence of transfer)
Section 4.8 (Table 2 updated with the frequency of transfer, footer also updated)
Section 10 (date updated)
Updated on 04 November 2024
File name
ie-spc-tivicay5mg-issue11draft1-clean-no headers.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- 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 04 November 2024
File name
ie-pl-tivicay5mg-issue9draft1-clean-no headers.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 12 July 2024
File name
ie-pl-tivicay5mg-issue8draft1-clean-no headers.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
Updated on 12 July 2024
File name
ie-spc-tivicay5mg-issue10draft1-clean-no headers.pdf
Reasons for updating
- 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)
Updated on 26 July 2023
File name
ieukni-spc-tivicay5mg-issue9draft1-clean.pdf
Reasons for updating
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 October 2022
File name
ieukni-spc-tivicay5mg-issue8draft1-clean.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.3 - Preclinical safety data
- 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 22 September 2022
File name
ieukni-spc-tivicay5mg-issue7draft1-clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- 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 22 September 2022
File name
ieukni-pl-tivicay5mg-issue7draft1-clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 06 September 2022
File name
ieukni-spc-tivicay5mg-issue6draft1-workingcopy-clean_emc.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- 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 06 September 2022
File name
ieukni-pl-tivicay5mg-issue6draft1-workingcopy-clean_emc.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 02 December 2021
File name
ieukni-spc-combined-tivicay5mg-issue4draft1.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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 02 December 2021
File name
ieukni-pl-combined-tivicay5mg-issue4draft1.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 07 October 2021
File name
ieukni-spc-tivicay5mg-issue3draft1.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.1 - List of excipients
- 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 5.1 - update to ATC code and information relating to the week 144 data from Gemini studies
Section 6.1 - update to the excipient naming
Updated on 07 October 2021
File name
ieukni-pl-tivicay5mg-issue3draft1.pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to further information section
- Change to date of revision
Updated on 17 February 2021
File name
ie-spc-tivicay5mg-issue2draft1.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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 - addition of bilirubin ADR as a result of the final clinical study report
Updated on 17 February 2021
File name
ie-pl-tivicay5mg-issue2draft1.pdf
Reasons for updating
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Section 4 - addition of bilirubin ADR as a result of the final clinical study report
Updated on 17 February 2021
File name
ie-spc-tivicay5mg-issue1draft1.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 February 2021
File name
ie-pl-tivicay5mg-issue1draft1.pdf
Reasons for updating
- New PIL for new product
ViiV Healthcare BV
Address:
12 Riverwalk, Citywest Business Campus, Dublin 24, IrelandTelephone:
+353 1 495 5000Medical Information Direct Line:
1 800 244 255