Vocabria 30 mg film-coated tablets
*Company:
ViiV Healthcare BVStatus:
No Recent UpdateLegal 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 24 July 2024
File name
ie-spc-vocabria30mgtabs-issue9 draft1.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Project Windsor-removal of Northern Ireland from adverse reporting details
Updated on 24 July 2024
File name
ie-pl-vocabria30mgtabs-issue8 draft2.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
Free text change information supplied by the pharmaceutical company
Project Windsor-removal of Northern Ireland from adverse reporting details
Updated on 24 January 2023
File name
ieukni-spc-vocabria30mgtabs -issue8 draft1 - no headers.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 5.1 - Pharmacodynamic properties
- 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 24 January 2023
File name
ieukni-pl-vocabria30mgtabs-issue7 draft1 - no headers.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 24 October 2022
File name
ieukni-spc-vocabria30mgtabs-issue7draft1-no headers.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- 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 4.2:
- Under Missed Injections Section - Added statement that limited date is available on oral bridging with other ARTs.
Section 4.4:
- Under heading "Baseline factors associated with virological failure" - Added statement regarding virologic failure when using the every 2 month dosing regimen vs monthly dosing regimen.
- Under heading "Hypersensitivity reactions" - Changed "see section 4.2..." to "See section 4.2...".
Section 5.1
- Added data related to the Week 96 and Week 152 data from the ATLAS-2M study (significant updates including some replacement of text).
- Added paragraph related to "Oral bridging with other ART"
Section 5.2
Table 13 "Pharmacokinetic parameters following cabotegravir orally once daily, and initiation, monthly and every 2 month continuation intramuscular injections" - Corrected units in table to read "µg•h/mL" and "µg/mL" instead of "µ•h/mL" and "µ/mL"
Section 10
Updated revision date
Updated on 24 October 2022
File name
ieukni-pl-vocabria30mgtabs-issue6draft1-no headers.pdf
Reasons for updating
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Section 3, If you cannot receive your Vocabria injection
Updated to reflect the fact that an alternative oral treatment may be used in place of Vocabria tablets.
Section 6
Revision date updated to 09/2022
Updated on 30 August 2022
File name
ieukni-spc-vocabria30mgtabs-issue6draft2-no headers.pdf
Reasons for updating
- 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)
Free text change information supplied by the pharmaceutical company
Updated wording in Breastfeeding section only and replaced "HIV infected women" with "women living with HIV".
Date of revision of text updated due to the change outlined above.
Updated on 30 August 2022
File name
ieukni-pl-vocabria30mgtabs-issue5draft2-no header.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
Free text change information supplied by the pharmaceutical company
Updated wording in Breastfeeding section only and replaced "HIV infected women" with "women living with HIV"
Updated on 11 July 2022
File name
ieukni-pl-vocabria30mgtabs-issue5draft1-no headers.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Section 2 - Warnings and Precautions Section:
- Update to Allergic Reactions
- Deletion of paragraph entitled "Protect other people"
- Update to Breastfeeding section
Section 4 Possible Side Effects
- Position of Allergic Reactions section changed with additional updates including addition of hives (see 30 mg PIL tracked changes version for better clarity)
- Addition of Type I hypersensitivity, hives (urticaria) and swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing to Uncommon Side Effects
Section 6 Date of Revision
- Date of revision updated
Updated on 11 July 2022
File name
ieukni-spc-vocabria30mgtabs-issue6draft1-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 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 4.4 - Updated under Hypersensitivity Reactions Heading
Section 4.4 - Deletion of paragraph under Transmission of HIV Heading
Section 4.6 - Update to Breastfeeding section
Section 4.8 - Updates to Tabulated Summary of Adverse Reactions (addition of Type I Hypersensitivity, Urticaria and Angioedema and cross ref at bottom of table to Section 4.4
Updated on 23 March 2022
File name
ieukni-spc-vocabria30mgtabs-issue5draft1- Master-medie.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 23 March 2022
File name
ieukni-pl-vocabria30mgtabs-issue4draft1- Master-medie.pdf
Reasons for updating
- New PIL for new product