2026 – Page 7 – State Expert Center of the Ministry of Health of Ukraine

Regarding amendments to the instructions for medical use of medicinal products containing simvastatin (simvastatin)

28.04.2026 474

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 captopril (captopril)

28.04.2026 617

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 tranexamic acid (tranexamic acid) following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 27 – 30 October 2025

16.04.2026 1124

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 clozapine (clozapine) following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 27 – 30 October 2025

16.04.2026 516

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 of safety information for medicinal products containing galantamine, based on the results of the signal review by the PRAC committee at its meeting on 09-12 March 2026

10.04.2026 281

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 caffeine/codeine/paracetamol/propyphenazone and acetylsalicylic acid/caffeine/codeine/paracetamol based on the results of the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 12 – 15 January 2026

10.04.2026 699

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 codeine/paracetamol (codeine/paracetamol) following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 27 – 30 October 2025

10.04.2026 589

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 isotretinoin for oral use [isotretinoin (oral formulations)]

10.04.2026 599

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…

The European Medicines Agency (EMA) recommends withdrawing the registration certificates for medicinal products containing levamisole Leukoencephalopathy has been confirmed as a serious adverse reaction with the use of levamisole

08.04.2026 538

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 nefopam

06.04.2026 566

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 simvastatin (simvastatin)

Regarding amendments to the instructions for medical use of medicinal products containing captopril (captopril)

Changes to the safety information of medicinal products containing tranexamic acid (tranexamic acid) following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 27 – 30 October 2025

Changes to the safety information of medicinal products containing clozapine (clozapine) following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 27 – 30 October 2025

Update of safety information for medicinal products containing galantamine, based on the results of the signal review by the PRAC committee at its meeting on 09-12 March 2026

Changes to the safety information of medicinal products containing caffeine/codeine/paracetamol/propyphenazone and acetylsalicylic acid/caffeine/codeine/paracetamol based on the results of the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 12 – 15 January 2026

Changes to the safety information of medicinal products containing codeine/paracetamol (codeine/paracetamol) following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 27 – 30 October 2025

Regarding amendments to the instructions for medical use of medicinal products containing isotretinoin for oral use [isotretinoin (oral formulations)]

The European Medicines Agency (EMA) recommends withdrawing the registration certificates for medicinal products containing levamisole Leukoencephalopathy has been confirmed as a serious adverse reaction with the use of levamisole

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

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