Current information on the safety of medicinal products

Update of safety information for medicinal products containing risperidone [oral solution], adopted by the PRAC committee during the review of signals discussed at the meeting of 25-28 November 2024. Medication errors associated with accidental overdose in children and adolescents receiving risperidone oral solution 1 mg/mL

11.02.2025 916

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…

Safety information for medicinal products containing lenalidomide based on the results of the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 25-28 September 2023

05.02.2024 1342

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 pirfenidone-containing medicinal products adopted by the PRAC during the review of signals discussed at the meeting on 27-30 November 2023

22.01.2024 1366

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…

Isotretinoin: new safety measures to be introduced in the coming months, including additional supervision of treatment initiation in patients under 18 years of age

01.11.2023 4260

Expert Working Group on isotretinoin (isotretinoin) of the Commission on Human Medicines (CHM) of the Agency for the Regulation of Medicinal Products and…

Changes to the safety information on hydrocortisone-containing medicinal products based on the results of the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 05-08 June 2023

26.10.2023 1112

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 Ministry of Health of Canada (Health Canada) has published amendments to the instructions for medical use of medicinal products containing ulipristal acetate (ulipristal acetate)

25.07.2023 935

This overview is intended primarily for healthcare professionals. It provides a brief summary of key safety information…

The Ministry of Health of Canada (Health Canada) has published amendments to the instructions for medical use of medicinal products containing mercaptopurine

25.07.2023 994

This overview is intended primarily for healthcare professionals. It provides a brief summary of key safety information…

Occurrence of intraocular hemorrhages with monotherapy or combination therapy with antithrombotic medicinal products and anticoagulants

03.07.2023 2189

Objective: Intraocular hemorrhage is an adverse event that can lead to a deterioration in visual acuity. Therapy with antiplatelet agents and anticoagulants may increase…

The Pharmacovigilance Risk Assessment Committee (PRAC) has started a safety review of medicinal products containing hydroxyprogesterone (hydroxyprogesterone)

12.06.2023 932

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 Ministry of Health of Canada (Health Canada) has published a safety review of medicinal products containing rocuronium

04.05.2023 1354

This overview is intended primarily for healthcare professionals. It provides a brief summary of key safety information…

Safety information for medicinal products containing lenalidomide based on the results of the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 25-28 September 2023

Update of safety information on pirfenidone-containing medicinal products adopted by the PRAC during the review of signals discussed at the meeting on 27-30 November 2023

Isotretinoin: new safety measures to be introduced in the coming months, including additional supervision of treatment initiation in patients under 18 years of age

Changes to the safety information on hydrocortisone-containing medicinal products based on the results of the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 05-08 June 2023

The Ministry of Health of Canada (Health Canada) has published amendments to the instructions for medical use of medicinal products containing ulipristal acetate (ulipristal acetate)

The Ministry of Health of Canada (Health Canada) has published amendments to the instructions for medical use of medicinal products containing mercaptopurine

Occurrence of intraocular hemorrhages with monotherapy or combination therapy with antithrombotic medicinal products and anticoagulants

The Pharmacovigilance Risk Assessment Committee (PRAC) has started a safety review of medicinal products containing hydroxyprogesterone (hydroxyprogesterone)

The Ministry of Health of Canada (Health Canada) has published a safety review of medicinal products containing rocuronium

Forum "PHARMEXPERT 2026: pharmaceutical market in the new regulatory reality"

Forum "Clinical and preclinical studies in wartime: organization and development prospects"

Pharmaceutical forum "PHARMEXPERT 2025. eCTD and pricing in Ukraine – a strategic path to integration into the international regulatory space"

PHARMEXPERT 2024. Standards. Innovations. European integration