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

Regarding amendments to the instructions for medical use of medicinal products containing codeine / paracetamol

10.07.2026 373

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 inserts for medicinal products containing testosterone [for topical use]

10.07.2026 283

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 caffeine/codeine/paracetamol/propyphenazone (caffeine/codeine/paracetamol/propyphenazone) and acetylsalicylic acid/caffeine/codeine/paracetamol (acetylsalicylic acid/caffeine/codeine/paracetamol)

08.07.2026 410

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 piretanide / ramipril, piretanide

30.06.2026 793

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 buclizine/codeine/paracetamol, acetylsalicylic acid/codeine/paracetamol, caffeine/codeine/paracetamol

29.06.2026 436

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 for medicinal products containing pancreatin following the signal review by the Pharmacovigilance Risk Assessment Committee (PRAC) at the meeting on May 04 – 07, 2026

26.06.2026 534

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 502

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 383

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 541

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 326

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 amendments to the instructions for medical use of medicinal products containing codeine / paracetamol

Regarding amendments to the package inserts for medicinal products containing testosterone [for topical use]

Regarding amendments to the instructions for medical use of medicinal products containing caffeine/codeine/paracetamol/propyphenazone (caffeine/codeine/paracetamol/propyphenazone) and acetylsalicylic acid/caffeine/codeine/paracetamol (acetylsalicylic acid/caffeine/codeine/paracetamol)

Regarding amendments to the instructions for medical use of medicinal products containing piretanide / ramipril, piretanide

Regarding amendments to the instructions for medical use of medicinal products containing buclizine/codeine/paracetamol, acetylsalicylic acid/codeine/paracetamol, caffeine/codeine/paracetamol

Update of safety information for medicinal products containing pancreatin following the signal review by the Pharmacovigilance Risk Assessment Committee (PRAC) at the meeting on May 04 – 07, 2026

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)

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