BfArM - Federal Institute for Drugs and Medical Devices

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Expert Advisory Committee for Prescription-Only Issues Date: 30. June 2023 Topics: Arzneimittelsicherheit Pharmakovigilanz Type: Article

Meetings of the Expert Advisory Committee for Prescription-Only Issues (in accordance with section 53 German Medicines Act) take place twice yearly (January/June).

Instructions for submission of an application for changing the legal status Date: 30. June 2023 Topics: Arzneimittelsicherheit Pharmakovigilanz Type: Article

Instructions for submission of an application for changing the legal status

Direct Healthcare Professional Communication (DHPC) on Gavreto▼ (pralsetinib): Increased risk for tuberculosis and measures to minimize this risk PDF, 389KB, File is accessible Date: 16. June 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pralsetinib

Roche Pharma AG informs about the occurrence of mostly extrapulmonary tuberculosis in patients treated with Gavreto.

Direct Healthcare Professional Communication (DHPC) on systemic and inhaled fluoroquinolone antibiotics: reminder on restrictions of use PDF, 379KB, File does not meet accessibility standards Date: 07. June 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ciprofloxacin, delafloxacin, levofloxacin, moxifloxacin, norfloxacin, ofloxacin

The marketing authorisation holders of fluoroquinolone antibiotics in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM), would like to remind of the recent study data which suggest that …

Direct Healthcare Professional Communication (DHPC) on Cyclophosphamid beta 500 mg/ml, 1000 mg/2 ml, 2000 mg/4 ml concentrate for solution for injection/infusion (cyclophosphamide): Contraindicated in children and adolescents due to alcohol content PDF, 120KB, File is accessible Date: 01. June 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: cyclophosphamide

betapharm Arzneimittel GmbH informs that cyclophosphamide beta concentrate for solution for injection/infusion is contraindicated for children and adolescents due to the alcohol content.

Direct Healthcare Professional Communication (DHPC) on recall of the epinephrine auto-injector Emerade® 300/500 microgramm pre-filled pen: Patients should replace product PDF, 1MB, File is accessible Date: 26. May 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Epinephrine

The marketing authorisation holder Pharma Swiss Česká republika s.r.o. and the distributor Dr. Gerhard Mann chem.-pharm. Fabrik GmbH inform in consultation with the local competent authority (Landesamt für Gesundheit und Soziales, Berlin), that all …

Direct Healthcare Professional Communication (DHPC) on propofol: risk of sepsis with multiple withdrawals from one container PDF, 172KB, File is accessible Date: 16. May 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: propofol

The marketing authorisation holders of propofol-containing medicinal products provide information that propofol-containing medicinal products are only authorised for single use in a single patient.

Methotrexate-containing medicinal products: improving risk awareness by changing risk-minimising measures - results of a study commissioned by the EMA Date: 30. March 2023 Topics: Pharmakovigilanz Type: Risk information

Active substance: methotrexate

The study commissioned by the EMA to review the effectiveness of mandated measures to minimise medication errors in therapy with methotrexate-containing medicinal products has been completed. The study results and possible resulting safety measures …

Information Letter on Mitem 20 mg of the company Substipharm: Withdrawal of the restriction for intravenous administration PDF, 86KB, File does not meet accessibility standards Date: 22. March 2023 Topics: Pharmakovigilanz Type: Risk information

Active substance: Mitomycin

Substipharm informs that the mitomycin-containing medicinal product Mitem® 20 mg - powder for the preparation of a solution for injection or infusion or powder and solvent for the preparation of a solution can be used again for intravenous …

Direct Healthcare Professional Communication (DHPC) on Janus kinase inhibitors: Updated recommendations for risk minimisation Date: 17. March 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Janus kinase inhibitors

AbbVie, Galapagos, Lilly and Pfizer in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) would like to inform you about the updated recommendations for risk minimisation regarding the …