2025 – Page 11 – State Expert Center of the Ministry of Health of Ukraine

2025

Changes to the safety information of medicinal products containing insulin glargine / lixisenatide (insulin glargine / lixisenatide) following the results of the Pharmacovigilance Risk Assessment Committee (PRAC) meeting of 10 – 13 June 2024

14.01.2025 632

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 on ibrutinib-containing medicinal products based on the results of the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 10 – 13 June 2024

14.01.2025 544

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 metamizole

08.01.2025 1151

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…

Measures to minimize the serious consequences of a known adverse reaction when using analgesics containing metamizole

08.01.2025 2977

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 insulin glargine / lixisenatide (insulin glargine / lixisenatide) following the results of the Pharmacovigilance Risk Assessment Committee (PRAC) meeting of 10 – 13 June 2024

Changes to the safety information on ibrutinib-containing medicinal products based on the results of the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 10 – 13 June 2024

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

Measures to minimize the serious consequences of a known adverse reaction when using analgesics containing metamizole

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