2026 – Page 6 – State Expert Center of the Ministry of Health of Ukraine

Changes to the safety information of medicinal products containing polatuzumab vedotin (polatuzumab vedotin) following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 12 – 15 January 2026

11.05.2026 375

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 atezolizumab following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 12 – 15 January 2026

11.05.2026 416

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 methadone

11.05.2026 462

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 nicardipine (nicardipine)

11.05.2026 339

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 dabrafenib-containing medicinal products based on the results of the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 12 – 15 January 2026

11.05.2026 306

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 cefixime

04.05.2026 788

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 tamoxifen (tamoxifen)

29.04.2026 411

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 cefditoren (cefditoren)

29.04.2026 294

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 semaglutide following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of November 24 – 27, 2025

29.04.2026 519

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 telmisartan (telmisartan)

29.04.2026 530

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 polatuzumab vedotin (polatuzumab vedotin) following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 12 – 15 January 2026

Changes to the safety information of medicinal products containing atezolizumab following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 12 – 15 January 2026

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

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

Changes to the safety information on dabrafenib-containing medicinal products based on the results of the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 12 – 15 January 2026

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

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

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

Changes to the safety information of medicinal products containing semaglutide following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of November 24 – 27, 2025

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

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