2026 – Page 4 – State Expert Center of the Ministry of Health of Ukraine

Щодо внесення змін до інструкцій для медичного застосування лікарських засобів, що містять буклізин/кодеїн/парацетамол (buclizine/codeine/paracetamol), ацетилсаліцилову кислоту/кодеїн/парацетамол (acetylsalicylic acid/codeine/paracetamol), кофеїн/кодеїн/парацетамол (caffeine/codeine/paracetamol)

29.06.2026 350

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…

Оновлення інформації з безпеки лікарських засобів, що містять панкреатин (pancreatin) за результатами огляду сигналів Комітетом з оцінки ризиків у фармаконагляді (PRAC) на засіданні 04 – 07 травня 2026 року

26.06.2026 481

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 perampanel following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 09 – 12 March 2026

22.06.2026 329

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 upadacitinib following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 09 – 12 March 2026

16.06.2026 264

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 буклізин/кодеїн/парацетамол (buclizine/codeine/paracetamol), ацетилсаліцилову кислоту/кодеїн/парацетамол (acetylsalicylic acid/codeine/paracetamol), кофеїн/кодеїн/парацетамол (caffeine/codeine/paracetamol) за результатами засідання Комітету з оцінки ризиків у фармаконагляді (PRAC) від 09 – 12 березня 2026 року

12.06.2026 396

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 choline salicylate / cetalkonium chloride (cetalkonium / choline salicylate)

11.06.2026 247

In accordance with paragraph 8 of Section IV of the Procedure for Conducting Expert Evaluation, the applicant must make changes to the package insert of a medicinal product in the event of…

Changes to the safety information for medicinal products containing ofatumumab following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 09 – 12 March 2026

11.06.2026 271

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 clozapine (clozapine)

09.06.2026 242

In accordance with paragraph 8 of Section IV of the Procedure for Conducting Expert Evaluation, the applicant must amend the package insert for the medicinal product in…

Changes to the safety information of the vaccine for the prevention of rotavirus infection (live) [rotavirus vaccine, live] based on the results of the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 09 – 12 February 2026

09.06.2026 281

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 albendazole (albendazole)

09.06.2026 418

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 perampanel following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 09 – 12 March 2026

Changes to the safety information for medicinal products containing upadacitinib following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 09 – 12 March 2026

On amending the package inserts for medicinal products containing choline salicylate / cetalkonium chloride (cetalkonium / choline salicylate)

Changes to the safety information for medicinal products containing ofatumumab following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 09 – 12 March 2026

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

Changes to the safety information of the vaccine for the prevention of rotavirus infection (live) [rotavirus vaccine, live] based on the results of the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 09 – 12 February 2026

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

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