2026 – Page 2 – State Expert Center of the Ministry of Health of Ukraine

Changes to the safety information of medicinal products containing laronidase following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 08 – 11 June 2026

21.09.2026 228

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 methotrexate

21.09.2026 277

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 ranibizumab following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 08 – 11 June 2026

11.09.2026 262

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 acalabrutinib (acalabrutinib) following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 08 – 11 June 2026

11.09.2026 252

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 of medicinal products containing choline salicylate

08.09.2026 348

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 acetylsalicylic acid (acetylsalicylic acid) following the results of the meeting of the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) held on 19 – 20 May 2026

08.09.2026 450

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 / dimenhydrinate (caffeine / dimenhydrinate), dimenhydrinate (dimenhydrinate)

08.09.2026 242

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 of medicinal products containing carbidopa / levodopa and foscarbidopa / foslevodopa

01.09.2026 231

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 of medicinal products containing α-tocopheryl, α-tocopherol, vitamin E (a-tocopheril, a-tocopherol, vitamin E)

01.09.2026 315

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 тербінафін (terbinafine)

01.09.2026 308

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 laronidase following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 08 – 11 June 2026

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

Changes to the safety information of medicinal products containing ranibizumab following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 08 – 11 June 2026

Changes to the safety information of medicinal products containing acalabrutinib (acalabrutinib) following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 08 – 11 June 2026

Regarding amendments to the package inserts of medicinal products containing choline salicylate

Changes to the safety information for medicinal products containing acetylsalicylic acid (acetylsalicylic acid) following the results of the meeting of the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) held on 19 – 20 May 2026

Regarding amendments to the instructions for medical use of medicinal products containing caffeine / dimenhydrinate (caffeine / dimenhydrinate), dimenhydrinate (dimenhydrinate)

Regarding amendments to the package inserts of medicinal products containing carbidopa / levodopa and foscarbidopa / foslevodopa

Regarding amendments to the package inserts of medicinal products containing α-tocopheryl, α-tocopherol, vitamin E (a-tocopheril, a-tocopherol, vitamin E)

Щодо внесення змін до інструкцій для медичного застосування лікарських засобів, що містять тербінафін (terbinafine)

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