Tivicay 5mg dispersible tablets
*Company:
ViiV Healthcare BVStatus:
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 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