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.
Based on the assessment of Periodic Safety Update Reports (PSURs) for medicinal products containing choline salicylate, PSUSA/00000732/202512, the Pharmacovigilance Risk Assessment Committee (PRAC) reached the following conclusions.
Given the available data on medicinal products of the same therapeutic class and taking into account the plausible mechanism of action, it is considered that for medicinal products containing choline salicylate, a warning should be added regarding the risk of use during pregnancy. In addition, on the basis of the available data presented in a scientific article, it is considered that for medicinal products containing choline salicylate for oromucosal use, a warning should be added regarding use in patients with a history of peptic ulcer or an existing peptic ulcer. Also, given the available data on the therapeutic class of salicylates and the risk of salicylate poisoning, a warning regarding concomitant use of salicylates is also considered appropriate for medicinal products containing choline salicylate for oromucosal use.
Having considered the PRAC recommendations, the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) agrees with the overall conclusions of the PRAC and the grounds for the recommendations.
On the basis of the scientific conclusions regarding choline salicylate (choline salicylate), the CMDh considers that the benefit / risk balance of medicinal products containing choline salicylate (choline salicylate) remains unchanged, provided that the proposed amendments are made to the instructions for medical use.
Changes to be made to the relevant sections of the instruction for medical use (new text underlined and in bold).
Choline salicylate: for topical, otic and oromucosal use
Section “Use during pregnancy or breastfeeding”
Pregnancy
There are no clinical data on the use of [name of medicinal product] during pregnancy. Even if systemic exposure is lower compared with oral use, it is not known whether the systemic exposure to [name of medicinal product] achieved after topical use may be harmful to the embryo / fetus. During the first and second trimesters of pregnancy, [name of medicinal product] should be used only in case of absolute necessity. If used, the dose should be as low as possible and the duration of treatment as short as possible.
In the third trimester of pregnancy, systemic use of prostaglandin synthetase inhibitors, including [name of medicinal product], may cause cardiopulmonary and renal toxicity in the fetus. At the end of pregnancy, prolonged bleeding time may occur in both the mother and the newborn, as well as a delay in the onset of labor. Therefore, [name of medicinal product] should not be used during the last trimester of pregnancy.
Choline salicylate: for oromucosal use
“Special precautions for use” section
[…]
This medicinal product contains salicylate and should not be used together with aspirin or other salicylates, unless prescribed by a doctor or dentist.
This medicinal product should be used with caution in patients with active or recurrent peptic ulcer.
List of medicinal products containing choline salicylate and authorized for medical use in Ukraine (according to the State Register of Medicinal Products as of 02.09.2026). (9.6 KB) (Downloaded: 08.09.2026 10:38:05)
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:
