2025 – State Expert Center of the Ministry of Health of Ukraine

Regarding amendments to the instructions for medical use of medicinal products containing disodium hydrogen phosphate / sodium dihydrogen phosphate, sodium phosphate (disodium hydrogen phosphate / sodium dihydrogen phosphate, phosphate sodium)

30.12.2025 361

In accordance with paragraph 8 of Section IV of the Procedure for conducting expert evaluation, the applicant must amend the instruction for medical use of the medicinal product…

Regarding amendments to the instructions for medical use of medicinal products containing botulinum neurotoxin type A (150 kD) free from complexing proteins (botulinum neurotoxin type a (150 kd) free from complexing proteins)

30.12.2025 380

In accordance with paragraph 8 of Section IV of the Procedure for conducting expert evaluation, the applicant must amend the instruction for medical use of the medicinal product…

Regarding amendments to the instructions for medical use of medicinal products containing caspofungin

25.12.2025 329

In accordance with paragraph 8 of Section IV of the Procedure for conducting expert evaluation, the applicant must amend the instruction for medical use of the medicinal product…

On amendments to the instructions for medical use of medicinal products containing botulinum toxin type A (botulinum toxin a)

22.12.2025 643

In accordance with paragraph 8 of Section IV of the Procedure for conducting expert evaluation, the applicant must amend the instruction for medical use of the medicinal product…

Regarding amendments to the instructions for medical use of medicinal products containing bupropion

15.12.2025 967

In accordance with paragraph 8 of Section IV of the Procedure for conducting expert evaluation, the applicant must amend the instruction for medical use of the medicinal product…

Regarding amendments to the package leaflets of medicinal products containing testosterone [all dosage forms, except products for topical use]

12.12.2025 705

In accordance with paragraph 8 of Section IV of the Procedure for conducting expert evaluation, the applicant must amend the instruction for medical use of the medicinal product…

Update on the safety information for medicinal products containing bosutinib, adopted by the PRAC during the review of signals discussed at the meeting of 27-30 October 2025

09.12.2025 364

In accordance with paragraph 8 of Section IV of the Procedure for conducting expert evaluation, the applicant must amend the instruction for medical use of the medicinal product…

Changes in the use of medicinal products containing azithromycin. The recommendations are aimed at optimizing use and minimizing the development of antimicrobial resistance

08.12.2025 641

In accordance with paragraph 8 of Section IV of the Procedure for conducting expert evaluation, the applicant must amend the instruction for medical use of the medicinal product…

Changes to the safety information of medicinal products containing azathioprine following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 7 – 10 July 2025

24.11.2025 421

In accordance with paragraph 8 of Section IV of the Procedure for conducting expert evaluation, the applicant must amend the instruction for medical use of the medicinal product…

Changes to the safety information of medicinal products containing bosentan following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 7 – 10 July 2025

18.11.2025 341

In accordance with paragraph 8 of Section IV of the Procedure for conducting expert evaluation, the applicant must amend the instruction for medical use of the medicinal product…

Regarding amendments to the instructions for medical use of medicinal products containing disodium hydrogen phosphate / sodium dihydrogen phosphate, sodium phosphate (disodium hydrogen phosphate / sodium dihydrogen phosphate, phosphate sodium)

Regarding amendments to the instructions for medical use of medicinal products containing botulinum neurotoxin type A (150 kD) free from complexing proteins (botulinum neurotoxin type a (150 kd) free from complexing proteins)

Regarding amendments to the instructions for medical use of medicinal products containing caspofungin

On amendments to the instructions for medical use of medicinal products containing botulinum toxin type A (botulinum toxin a)

Regarding amendments to the instructions for medical use of medicinal products containing bupropion

Regarding amendments to the package leaflets of medicinal products containing testosterone [all dosage forms, except products for topical use]

Update on the safety information for medicinal products containing bosutinib, adopted by the PRAC during the review of signals discussed at the meeting of 27-30 October 2025

Changes in the use of medicinal products containing azithromycin. The recommendations are aimed at optimizing use and minimizing the development of antimicrobial resistance

Changes to the safety information of medicinal products containing azathioprine following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 7 – 10 July 2025

Changes to the safety information of medicinal products containing bosentan following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 7 – 10 July 2025

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