2024 – Page 11 – State Expert Center of the Ministry of Health of Ukraine

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

03.04.2024 1178

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 pseudoephedrine

22.03.2024 1296

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 fentanyl (fentanyl) (transdermal patches, solution for injection)

21.03.2024 1342

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 for medicinal products containing tobramycin (solution for inhalation), following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 10-12 May 2023

07.03.2024 985

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 for medicinal products containing infliximab following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 23-26 October 2023

07.03.2024 1190

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 for medicinal products containing pramipexole following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 23-26 October 2023

07.03.2024 1255

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 dolutegravir/abacavir/lamivudine (dolutegravir/abacavir/lamivudine)

07.03.2024 888

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 abacavir/lamivudine

07.03.2024 1107

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 abacavir (abacavir)

07.03.2024 860

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 for medicinal products containing parecoxib following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 27 – 30 November 2023

07.03.2024 1289

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 mifepristone (mifepristone)

Regarding amendments to the package leaflets of medicinal products containing pseudoephedrine

On amending the package inserts for medicinal products containing fentanyl (fentanyl) (transdermal patches, solution for injection)

Changes to the safety information for medicinal products containing tobramycin (solution for inhalation), following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 10-12 May 2023

Changes to the safety information for medicinal products containing infliximab following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 23-26 October 2023

Changes to the safety information for medicinal products containing pramipexole following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 23-26 October 2023

On amending the package inserts for medicinal products containing dolutegravir/abacavir/lamivudine (dolutegravir/abacavir/lamivudine)

Regarding amendments to the package leaflets of medicinal products containing abacavir/lamivudine

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

Changes to the safety information for medicinal products containing parecoxib following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 27 – 30 November 2023

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