2023 – Page 9 – State Expert Center of the Ministry of Health of Ukraine

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

10.03.2023 1110

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…

The European Medicines Agency (EMA) confirms measures to minimize the risk of serious side effects with the use of Janus kinase inhibitors for the treatment of chronic inflammatory diseases

27.02.2023 1009

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 amendments to the instructions for medical use of medicinal products containing amoxicillin (amoxicillin); methotrexate (methotrexate)

23.02.2023 2012

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 erythromycin [for systemic use]

23.02.2023 1531

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 instruction for medical use of medicinal products containing cefuroxime axetil (cefuroxime axetil) and cefuroxime sodium (cefuroxime sodium) [except for intracameral use]

23.02.2023 1606

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 bleomycin (bleomycin)

23.02.2023 868

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…

New measures to minimize the risk of developing meningioma with medicinal products containing nomegestrol (nomegestrol) or chlormadinone (chlormadinone)

25.01.2023 1487

The EMA (European Medicines Agency) Committee for Medicinal Products for Human Use (CHMP) endorsed the recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC),…

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

16.01.2023 2834

The Pharmacovigilance Risk Assessment Committee (PRAC), based on the assessment of the analysis of Periodic Safety Update Reports (PSURs) for medicinal products,…

On amending the instructions for medical use of medicinal products containing oxycodone (oxycodone)

16.01.2023 1809

The Pharmacovigilance Risk Assessment Committee (PRAC), based on the analysis of Periodic Safety Update Reports (PSURs) for medicinal products containing…

Regarding amendments to the instructions for medical use of medicinal products containing ketoprofen [for topical use only]

13.01.2023 1056

The Pharmacovigilance Risk Assessment Committee (PRAC), based on the assessment of the analysis of Periodic Safety Update Reports (PSURs) for medicinal products,…

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

The European Medicines Agency (EMA) confirms measures to minimize the risk of serious side effects with the use of Janus kinase inhibitors for the treatment of chronic inflammatory diseases

On amendments to the instructions for medical use of medicinal products containing amoxicillin (amoxicillin); methotrexate (methotrexate)

Regarding amendments to the instructions for medical use of medicinal products containing erythromycin [for systemic use]

Regarding amendments to the instruction for medical use of medicinal products containing cefuroxime axetil (cefuroxime axetil) and cefuroxime sodium (cefuroxime sodium) [except for intracameral use]

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

New measures to minimize the risk of developing meningioma with medicinal products containing nomegestrol (nomegestrol) or chlormadinone (chlormadinone)

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

On amending the instructions for medical use of medicinal products containing oxycodone (oxycodone)

Regarding amendments to the instructions for medical use of medicinal products containing ketoprofen [for topical use only]

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