The State Expert Center of the Ministry of Health of Ukraine reminds registration certificate holders of the need to check and, if necessary, make appropriate changes to the registration materials / instructions for medical use of medicinal products containing angiotensin-converting enzyme (ACE) inhibitors, in accordance with the recommendations of the Pharmacovigilance Risk Assessment Committee (PRAC).
The relevant recommendations were formed based on the results of the single assessment of periodically updated safety reports for piretanide / ramipril, piretanide — PSUSA/00002434/202508. Based on the results of the procedure, a decision was made to amend the instructions for medical use.
Based on the results of the assessment, PRAC noted that angioedema may also occur after a long period of treatment with ACE inhibitors. The available data indicate that angioedema caused by ACE inhibitors is bradykinin-mediated and that epinephrine may be ineffective for its treatment. The relevant information is recommended to be included in the warnings regarding angioedema in the package leaflet. Incorrect information about the immediate use of epinephrine for the treatment of angioedema caused by ACE inhibitors should also be removed if such information is contained in the package leaflet.
PRAC concluded that the specified updated information should be applied to all medicinal products containing ACE inhibitors, including medicinal products with fixed combinations of active substances, and should be appropriately reflected in the package leaflet. CMDh agreed with the PRAC recommendations.
The previous publication can be found on the website of the State Expert Center of the Ministry of Health of Ukraine at the following link:
https://www.dec.gov.ua/materials/shhodo-vnesennya-zmin-do-instrukczij-dlya-medychnogo-zastosuvannya-likarskyh-zasobiv-shho-mistyat-piretanid-ramipryl-piretanide-ramipril-piretanid-piretanide-2/?role=applicant
List of international non-proprietary names (INNs) of active substances and their combinations for medicinal products for which verification and, if necessary, the introduction of appropriate changes to the package leaflets must be ensured:
- Atorvastatin, acetylsalicylic acid and ramipril
- Atorvastatin, amlodipine and perindopril
- Captopril
- Captopril and diuretics
- Enalapril
- Enalapril and diuretics
- Enalapril and lercanidipine
- Enalapril and nitrendipine
- Lisinopril
- Lisinopril and amlodipine
- Lisinopril and diuretics
- Perindopril
- Perindopril and amlodipine
- Perindopril and bisoprolol
- Perindopril and diuretics
- Perindopril, amlodipine and indapamide
- Ramipril
- Ramipril and amlodipine
- Ramipril and diuretics
- Ramipril, amlodipine and hydrochlorothiazide
- Rosuvastatin and ramipril
- Rosuvastatin, amlodipine and perindopril
- Rosuvastatin, perindopril and indapamide
- Zofenopril
- Zofenopril and diuretics
The list of medicinal products containing angiotensin-converting enzyme (ACE) inhibitors and authorized for medical use in Ukraine has been compiled based on data from the State Register of Medicinal Products of Ukraine as of 29.09.2026. (2.6 MB) (Downloaded: 05.10.2026 07:57:50)
Deadlines for introducing changes in Ukraine
In accordance with paragraph 8 of Chapter IV of the Procedure for conducting expert evaluation of registration materials for medicinal products, approved by order of the Ministry of Health of Ukraine dated 26.08.2005 No. 426 (as amended), the applicant must introduce changes to the instructions for medical use of a medicinal product upon receipt of new data, including bringing the instructions for medical use into compliance with the approved instructions for medical use of the original (reference) medicinal product, and guarantee that the information about the medicinal product corresponds to current scientific knowledge.
In accordance with paragraph 2 of Chapter VI of the said Procedure, if it is necessary to introduce changes to the instructions for medical use of a medicinal product regarding safety, the applicant shall notify the State Expert Center of the Ministry of Health of Ukraine thereof in any manner and submit an application for introducing changes no later than 60 calendar days from the date of receipt of information on the need to introduce such changes.
Please note! In the PRAC/CMDh documents for the relevant medicinal products in the European Union, the need to update the product information during the next relevant regulatory procedure or, at the latest, within one year is stated.
For medicinal products registered in Ukraine, applicants must be guided by the timeframes established by the legislation of Ukraine.
To analyse the published information, determine the need for and content of the relevant changes, and prepare an application for amendments to the registration materials, applicants must use the original PRAC, EMA and CMDh documents. At the same time, the timeframes for submitting the application for amendments are determined in accordance with the legislation of Ukraine.
