Vocabria 30 mg film-coated tablets *
Pharmacy Only: Prescription

  • Company:

    ViiV Healthcare UK Ltd
  • Status:

    No Recent Update
  • Legal 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 11 July 2022

File name

62cc5009ed725.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

62cc4efb7986b.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_1648027597.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_1648027562.pdf

Reasons for updating

  • New PIL for new product