In accordance with paragraph 8 of Section IV of the Procedure for Conducting Expert Evaluation, the applicant must amend the instructions for medical use of the medicinal product upon receipt of new data, including bringing the instructions for medical use into line with the approved instructions for medical use of the original (reference) medicinal product, and ensure that the information about the medicinal product corresponds to current scientific knowledge
Having considered the available evidence from the cumulative review submitted by the registration certificate holder of 9-valent human papillomavirus vaccine (recombinant, adsorbed) GARDASIL 9 and human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed) GARDASIL, the PRAC decided that the registration certificate holder (Merck Sharp & Dohme B.V.) must update the registration materials by making amendments as described below (new text is underlined).
“Adverse reactions” section
Subsection “General disorders and administration site reactions”
Induration at the injection site with a frequency of “Uncommon”
List of human papillomavirus vaccines authorized for medical use in Ukraine (according to the State Register of Medicinal Products as of 19.12.2024)
TO ANALYZE THE PUBLISHED INFORMATION AND SUBMIT THE CORRESPONDING APPLICATION FOR AMENDMENTS TO THE REGISTRATION MATERIALS, THE APPLICANT MUST USE THE ORIGINAL TEXT POSTED AT THE LINKS:
