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.
The previous publication can be found on the website of the State Expert Center of the Ministry of Health of Ukraine at the following links:
https://www.dec.gov.ua/materials/zminy-informacziyi-z-bezpeky-likarskyh-zasobiv-shho-mistyat-testosteron-testosterone-dlya-misczevogo-zastosuvannya-za-rezultatamy-zasidannya-komitetu-z-oczinky-ryzykiv-u-farmakonaglyadi-prac-vi-2/?role=doctors
https://www.dec.gov.ua/materials/zminy-informacziyi-z-bezpeky-likarskyh-zasobiv-shho-mistyat-testosteron-testosterone-dlya-misczevogo-zastosuvannya-za-rezultatamy-zasidannya-komitetu-z-oczinky-ryzykiv-u-farmakonaglyadi-prac-vi/?role=applicant
The Pharmacovigilance Risk Assessment Committee (PRAC), based on the analysis of Periodic Safety Update Reports (PSURs) for medicinal products containing testosterone [for topical use], PSUSA/00002908/202412, reached the following conclusions.
Given the available literature data on the risk of increased hemoglobin and hematocrit levels due to interaction with sodium-glucose cotransporter type 2 inhibitors (SGLT2 inhibitors), PRAC considers that a causal relationship between testosterone and SGLT2 inhibitors is at least reasonably possible. PRAC concluded that the instructions for medical use of medicinal products containing testosterone [for topical use] should be updated accordingly.
In view of the available literature data on secondary exposure of domestic animals to transdermal hormone-containing medicinal products, the PRAC concluded that the current recommendations to the patient on preventing accidental transfer of the medicinal product to other persons should be extended to also cover domestic animals. The PRAC concluded that the instructions for medical use of medicinal products containing testosterone [for topical use] must be updated accordingly.
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.
Based on the scientific conclusions on testosterone [for topical use], CMDh considers that the benefit/risk balance of medicinal products containing testosterone [for topical use] does not change, subject to the proposed amendments 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).
- Section "Method of administration and doses"
After use
[…]
Patients should be advised to keep the application site covered with clothing at all times to prevent accidental transfer of the medicinal product to other persons, as well as to pets.
- Section “Interaction with other medicinal products and other forms of interaction”
The following interaction should be added:
Insulin and other antidiabetic medicinal products:
Androgens may increase glucose tolerance and reduce the need for insulin or other antidiabetic medicinal products in patients with diabetes mellitus (see section “Special precautions for use”). Therefore, patients with diabetes mellitus should be monitored, especially at the beginning or end of treatment, and periodically during therapy (name of the medicinal product).
Concomitant use of testosterone replacement therapy and sodium-glucose cotransporter type 2 inhibitors (SGLT2 inhibitors) is associated with an increased risk of erythrocytosis. Since both substances can independently increase the hematocrit level, a cumulative effect is possible (see also the section “Special warnings and precautions for use”). In patients receiving both treatments, it is recommended to monitor hematocrit and hemoglobin levels.
List of medicinal products containing testosterone (for topical use) that are authorized for medical use in Ukraine (according to the State Register of Medicinal Products as of 07.07.2026). (12 KB) (Uploaded: 10.07.2026 12:09:15)
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:
