2023 – State Expert Center of the Ministry of Health of Ukraine

Regarding amendments to the instructions for medical use of medicinal products containing omega-3-acid ethyl esters (omega-3-acid ethyl esters)

15.12.2023 1895

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 beta-alanine

15.12.2023 1975

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 lomustine following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 25–28 September 2023

15.12.2023 1555

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 amending the package inserts for medicinal products containing lomustine

11.12.2023 1272

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 amending the package inserts for medicinal products containing etoposide

11.12.2023 1566

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…

Scientific conclusions and justification for the need to amend the registration materials/instructions for medical use of medicinal products containing topiramate (topiramate)

06.12.2023 2155

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 gemcitabine

04.12.2023 1657

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 the Risk Management Plan (RMP) of the reference medicinal product VFEND containing voriconazole

27.11.2023 2006

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 paroxetine

27.11.2023 1758

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…

Scientific conclusions of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and grounds for amending the registration materials of medicinal products containing sildenafil (sildenafil)

09.11.2023 1649

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 omega-3-acid ethyl esters (omega-3-acid ethyl esters)

Regarding amendments to the instructions for medical use of medicinal products containing beta-alanine

Changes to the safety information of medicinal products containing lomustine following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 25–28 September 2023

On amending the package inserts for medicinal products containing lomustine

On amending the package inserts for medicinal products containing etoposide

Scientific conclusions and justification for the need to amend the registration materials/instructions for medical use of medicinal products containing topiramate (topiramate)

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

Update of the Risk Management Plan (RMP) of the reference medicinal product VFEND containing voriconazole

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

Scientific conclusions of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and grounds for amending the registration materials of medicinal products containing sildenafil (sildenafil)

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