In April 2024, the EMA's Committee for Medicinal Products for Veterinary Use (CVMP) initiated a procedure to assess the need for including a maximum limit for histamine in gentamicin-containing medicinal products for parenteral administration to horses. This action was in response to adverse reactions linked to histamine residues in the active substance. (ema.europa.eu)
In February 2024, the EMA published the results of a periodic safety update report single assessment (PSUSA) for systemic gentamicin use, leading to variations in product information to enhance safety and efficacy. (ema.europa.eu)
In November 2025, the EMA updated the procedural steps and scientific information for Metalyse, a medicinal product containing tenecteplase, reflecting ongoing regulatory oversight and commitment to patient safety. (ema.europa.eu)
In October 2022, the EMA's CVMP adopted a positive opinion for Mometamax Ultra, a veterinary medicinal product containing gentamicin, mometasone furoate, and posaconazole, indicating continued regulatory approvals for gentamicin-containing products. (ema.europa.eu)
In September 2025, the EMA's CVMP highlighted the importance of pharmacovigilance and ongoing assessment of veterinary medicinal products, including those containing gentamicin, to ensure their continued safety and efficacy. (ema.europa.eu)
These developments underscore the dynamic regulatory environment surrounding gentamicin, emphasizing the need for exporters to stay informed and compliant with evolving standards and requirements.
