Vocabria 30 mg film-coated tablets

The CHMP, having considered in accordance with Article 28 of Regulation (EC) No 726/2004 the PSUR on the basis of the PRAC recommendation and the PRAC assessment report as appended, recommends by consensus, the variation to the terms of the marketing authorisation(s) for the above mentioned medicinal product(s), concerning the following change(s):

Update of sections 4.4 and 4.8 of the SmPC to add the severe cutaneous adverse reactions Stevens-Johnson syndrome/ Toxic epidermal necrolysis (SJS/TEN) with a frequency very rare and a warning/precaution regarding severe cutaneous adverse reactions. The Package leaflet is updated accordingly.

Update of section 4.8 of the SmPC to add the adverse reaction gait disturbance with a frequency rare. The Package leaflet is updated accordingly.

The CHMP, having considered in accordance with Article 28 of Regulation (EC) No 726/2004 the PSUR on the basis of the PRAC recommendation and the PRAC assessment report as appended, recommends by consensus, the variation to the terms of the marketing authorisation(s) for the above mentioned medicinal product(s), concerning the following change(s):

Update of sections 4.4 and 4.8 of the SmPC to add the severe cutaneous adverse reactions Stevens-Johnson syndrome/ Toxic epidermal necrolysis (SJS/TEN) with a frequency very rare and a warning/precaution regarding severe cutaneous adverse reactions. The Package leaflet is updated accordingly.

Update of section 4.8 of the SmPC to add the adverse reaction gait disturbance with a frequency rare. The Package leaflet is updated accordingly.

Project Windsor-removal of Northern Ireland from adverse reporting details

Project Windsor-removal of Northern Ireland from adverse reporting details

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

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 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 wording in Breastfeeding section only and replaced "HIV infected women" with "women living with HIV"

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

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