2026 – Page 5 – State Expert Center of the Ministry of Health of Ukraine

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 390

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 469

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 360

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 549

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 metronidazole/miconazole (metronidazole/miconazole) and chlorquinaldol/metronidazole (chlorquinaldol/metronidazole)

09.06.2026 357

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 tranexamic acid

09.06.2026 564

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…

Regarding changes to the prescribing information for medicinal products containing human normal immunoglobulin (IgG) [human normal immunoglobulin (IgG)]

27.05.2026 493

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…

Щодо внесення змін до інструкцій для медичного застосування лікарських засобів, що містять етодолак (etodolac)

27.05.2026 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…

Зміни інформації з безпеки лікарських засобів, що містять бромфенак (bromfenac) за результатами засідання Комітету з оцінки ризиків у фармаконагляді (PRAC) від 12 – 15 січня 2026 року

15.05.2026 401

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…

Щодо внесення змін до інструкцій для медичного застосування лікарських засобів, що містять мікофенолату мофетил (mycophenolate mofetil) та мікофенолову кислоту (mycophenolic acid)

15.05.2026 371

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 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)

Regarding amendments to the instructions for medical use of medicinal products containing metronidazole/miconazole (metronidazole/miconazole) and chlorquinaldol/metronidazole (chlorquinaldol/metronidazole)

Regarding amendments to the package leaflets of medicinal products containing tranexamic acid

Regarding changes to the prescribing information for medicinal products containing human normal immunoglobulin (IgG) [human normal immunoglobulin (IgG)]

Щодо внесення змін до інструкцій для медичного застосування лікарських засобів, що містять етодолак (etodolac)

Щодо внесення змін до інструкцій для медичного застосування лікарських засобів, що містять мікофенолату мофетил (mycophenolate mofetil) та мікофенолову кислоту (mycophenolic acid)

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