2024 – State Expert Center of the Ministry of Health of Ukraine

Regarding amendments to the package inserts of medicinal products containing amitriptyline, amitriptyline/amitriptylinoxide, amitriptylinoxide

14.01.2025 901

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 5-fluorouracil (5-fluorouracil) (for intravenous use)

30.12.2024 596

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 angiotensin II receptor blockers (ARBs): azilsartan, candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan, valsartan [single-component and combination medicinal products], adopted by the PRAC committee during its review of signals discussed at the meeting of 28-31 October 2024

26.12.2024 1167

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 the 9-valent human papillomavirus vaccine (recombinant, adsorbed) and the human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed), adopted by the PRAC committee during the review of signals discussed at the meeting of 08-11 July 2024

24.12.2024 708

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 paracetamol (single-component and combination medicinal products) adopted by the PRAC during the review of signals discussed at the meeting on 28-31 October 2024

24.12.2024 1838

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 medicinal products containing glucagon-like peptide-1 (GLP-1) receptor agonists: dulaglutide, exenatide, insulin degludec/liraglutide, liraglutide, insulin glargine/lixisenatide, lixisenatide, semaglutide, tirzepatide, adopted by the PRAC committee during the review of signals discussed at the meeting of 08-11 July 2024

23.12.2024 1616

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 levonorgestrel/ethinylestradiol, ethinylestradiol (levonorgestrel/ethinylestradiol, ethinylestradiol) (combination pack)

23.12.2024 1017

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 zoledronic acid (indications – malignant neoplasms and fractures)

20.12.2024 676

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 amiodarone

13.12.2024 696

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 terazosin

13.12.2024 838

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 amitriptyline, amitriptyline/amitriptylinoxide, amitriptylinoxide

On amending the instructions for medical use of medicinal products containing 5-fluorouracil (5-fluorouracil) (for intravenous use)

Update of safety information for the 9-valent human papillomavirus vaccine (recombinant, adsorbed) and the human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed), adopted by the PRAC committee during the review of signals discussed at the meeting of 08-11 July 2024

Update of safety information for medicinal products containing paracetamol (single-component and combination medicinal products) adopted by the PRAC during the review of signals discussed at the meeting on 28-31 October 2024

Regarding amendments to the instructions for medical use of medicinal products containing levonorgestrel/ethinylestradiol, ethinylestradiol (levonorgestrel/ethinylestradiol, ethinylestradiol) (combination pack)

Regarding amendments to the package leaflets of medicinal products containing zoledronic acid (indications – malignant neoplasms and fractures)

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

On amending the package inserts for medicinal products containing terazosin

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