To the attention of interested persons
Considering that, lately information related to the lack of efficacy of generics, explicitly referring to CEFORT (ceftriaxonum), powder for solution for injection/infusion, was publicly spread, the National Agency for Medicines and Medical Devices (NAMMD) has referred the matter to itself, immediately starting to sample the mentioned medicinal product for testing. One month after sampling, to the present day, physical-chemical and microbiological tests have been conducted in accordance with analysis methods of the European Pharmacopoeia and the specification for this medicinal product has been approved by the marketing authorisation.
The results of physical-chemical analyses, for qualitative and qualitative parameters, as well as the results of microbiological tests have confirmed the compliance of samples taken from CEFORT 1g, powder for solution for injection/infusion (ceftriaxonum) with requirements of the European Pharmacopoeia and with the specifications approved at authorisation.
To conclude, as opposed to the results of the tests performed, suspicions on the quality of this generic medicinal product have not been scientifically confirmed.
In addition, please be advised that, in accordance with NAMMD attributions, the authority’s 2016 Yearly Sampling and testing plan includes assessment of the quality of medicinal products, both generic and innovative.