2025 – Page 2 – State Expert Center of the Ministry of Health of Ukraine

On amendments to the instructions for medical use of medicinal products containing cyclosporine (ciclosporin) for systemic use

14.11.2025 392

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…

Зміни інформації з безпеки лікарських засобів, що містять леветирацетам (levetiracetam) за результатами засідання Комітету з оцінки ризиків у фармаконагляді (PRAC) від 7 – 10 липня 2025 року

14.11.2025 363

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 instructions for medical use of medicinal products containing miconazole, hydrocortisone / miconazole nitrate, miconazole nitrate / zinc oxide

04.11.2025 573

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…

Зміни інформації з безпеки лікарських засобів, що містять дарифенацин (darifenacin) за результатами засідання Комітету з оцінки ризиків у фармаконагляді (PRAC) від 2 – 5 червня 2025 року

04.11.2025 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…

Regarding amendments to the package leaflets of medicinal products containing methylphenidate (methylphenidate)

04.11.2025 942

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 phosphocreatine (phosphocreatine)

29.10.2025 522

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 nicotine

29.10.2025 421

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 safety information for medicinal products containing dabrafenib, trametinib, adopted by the PRAC upon review of signals discussed at the meeting of September 01-04, 2025*

28.10.2025 563

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 on osimertinib-containing medicinal products adopted by the PRAC during the review of signals discussed at the meeting on 01-04 September 2025

27.10.2025 535

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 levosimendan (levosimendan)

23.10.2025 638

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 amendments to the instructions for medical use of medicinal products containing cyclosporine (ciclosporin) for systemic use

On amending the instructions for medical use of medicinal products containing miconazole, hydrocortisone / miconazole nitrate, miconazole nitrate / zinc oxide

Regarding amendments to the package leaflets of medicinal products containing methylphenidate (methylphenidate)

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

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

Update of the safety information for medicinal products containing dabrafenib, trametinib, adopted by the PRAC upon review of signals discussed at the meeting of September 01-04, 2025*

Update of safety information on osimertinib-containing medicinal products adopted by the PRAC during the review of signals discussed at the meeting on 01-04 September 2025

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

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