In accordance with paragraph 8 of Section IV of the Procedure for 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 on the medicinal product corresponds to current scientific knowledge.
08 – 11 June 2026
Having reviewed the available data in EudraVigilance and the scientific literature, including the cumulative review received from the registration certificate holder(s) (RCH), the PRAC decided that RCHs of medicinal products containing iomeprol, iodixanol, ioversol, iopromide, iopamidol, iohexol, iobitridol and ioxitalamic acid must submit an application to amend the instructions for medical use as set out below (new text underlined).
“Adverse reactions” section
The following adverse reaction should be added to SOC “Skin and subcutaneous tissue disorders” with the frequency “not known”:
Fixed drug eruption
List of medicinal products containing iodixanol, iohexol, iopamidol, and iopromide and authorized for medical use in Ukraine (according to the State Register of Medicinal Products as of 31.07.2026). (14 KB) (Downloaded: 04.08.2026 09:53:07)
TO ANALYZE THE PUBLISHED INFORMATION AND SUBMIT THE RELEVANT APPLICATION FOR AMENDMENTS TO THE REGISTRATION MATERIALS, THE APPLICANT MUST USE THE ORIGINAL TEXT AVAILABLE AT THE FOLLOWING LINKS:
