EMA – Сторінка 20 – Державний експертний центр МОЗ України

On amending the package insert for medicinal products containing Hydrochlorothiazide

27.12.2018 3435

Dear applicants! The Pharmacovigilance Risk Assessment Committee of the European Medicines Agency (PRAC EMA), having considered the available evidence from EudraVigilance and…

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

27.12.2018 2712

Dear applicants! The Pharmacovigilance Risk Assessment Committee of the European Medicines Agency (PRAC EMA), having considered the available evidence from EudraVigilance and…

Regarding amendments to the instruction for medical use of medicinal products containing Direct acting antivirals (DAAV) (direct-acting antiviral drugs)

27.12.2018 5373

Dear applicants! The Pharmacovigilance Risk Assessment Committee of the European Medicines Agency (PRAC EMA), having considered the available evidence from EudraVigilance and…

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

27.12.2018 2640

Dear applicants! The Pharmacovigilance Risk Assessment Committee of the European Medicines Agency (PRAC EMA) considers that the limitations of the available data do not allow…

Regarding amendments to the package leaflets of medicinal products containing Teriflunomide

27.12.2018 3028

Dear applicants! The Pharmacovigilance Risk Assessment Committee of the European Medicines Agency (PRAC EMA), having reviewed the available evidence from EudraVigilance data, literature,…

Regarding amendments to the package leaflets of medicinal products containing Dolutegravir

27.12.2018 2787

Dear applicants! The Pharmacovigilance Risk Assessment Committee of the European Medicines Agency (PRAC EMA), having considered the available evidence obtained from preliminary data…

On amending the package insert for medicinal products containing Hydrochlorothiazide

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

Regarding amendments to the instruction for medical use of medicinal products containing Direct acting antivirals (DAAV) (direct-acting antiviral drugs)

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

Regarding amendments to the package leaflets of medicinal products containing Teriflunomide

Regarding amendments to the package leaflets of medicinal products containing Dolutegravir

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