Current information on the safety of medicinal products

The European Medicines Agency (EMA) is starting a review of medicinal products containing ipidacrine

17.08.2026 281

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 amikacin following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 04 – 07 May 2026

28.07.2026 371

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 tobramycin following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 04 – 07 May 2026

28.07.2026 274

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 trabectedin following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 04 – 07 May 2026

28.07.2026 343

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 metronidazole / neomycin / nystatin (metronidazole / neomycin / nystatin)

28.07.2026 303

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 the vaccine for the prevention of pneumococcal infection, polysaccharide (pneumococcal polysaccharide vaccine)

17.06.2026 332

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 on medicinal products containing levamisole following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 7 – 10 July 2025

24.11.2025 434

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…

Olanzapine. Potential risk of developing syndrome of inappropriate antidiuretic hormone secretion (SIADH)

11.06.2025 1061

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…

Bromocriptine (bromocriptine). The need for blood pressure monitoring

11.06.2025 763

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 mebendazole (mebendazole), based on a signal received by the Netherlands Pharmacovigilance Centre (Lareb)

30.05.2025 602

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) is starting a review of medicinal products containing ipidacrine

Changes to the safety information of medicinal products containing amikacin following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 04 – 07 May 2026

Changes to the safety information of medicinal products containing tobramycin following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 04 – 07 May 2026

Changes to the safety information of medicinal products containing trabectedin following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 04 – 07 May 2026

Regarding amendments to the instructions for medical use of medicinal products containing metronidazole / neomycin / nystatin (metronidazole / neomycin / nystatin)

Changes to the safety information of the vaccine for the prevention of pneumococcal infection, polysaccharide (pneumococcal polysaccharide vaccine)

Safety information on medicinal products containing levamisole following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 7 – 10 July 2025

Olanzapine. Potential risk of developing syndrome of inappropriate antidiuretic hormone secretion (SIADH)

Bromocriptine (bromocriptine). The need for blood pressure monitoring

Update of safety information for medicinal products containing mebendazole (mebendazole), based on a signal received by the Netherlands Pharmacovigilance Centre (Lareb)

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