REPORTS on preclinical studies and clinical trials

EMBOX_ preclinical

Report on preclinical studies of a generic medicinal product, which states that own preclinical studies are not submitted due to the proven therapeutic equivalence to the reference product, and all sections of pharmacology, pharmacokinetics and toxicology are marked as not conducted. compiled automatically

EMBOXA_clinic 1

Report on a clinical trial of bioequivalence of a generic medicinal product in tablet form compared with the reference product. The document contains a description of the study design, inclusion criteria, methods for assessing efficacy and safety, demographic indicators and results. compiled automatically

EMBOXA_clinic 2

Report on a bioequivalence clinical trial of a generic medicinal product of rivaroxaban in the form of tablets compared with the reference product. A phase I study was conducted in healthy volunteers to confirm bioequivalence and assess safety. compiled automatically

EMBOXA_clinic 3

Report on a bioequivalence clinical trial of a generic medicinal product of rivaroxaban in the form of crushed tablets compared with the reference product. A phase I study was conducted in healthy adult volunteers in Canada. compiled automatically

CLOMAX

Report on preclinical studies and a clinical trial report for a medicinal product in the form of a shampoo registered as a hybrid medicinal product. No own studies were conducted; instead, materials on pharmaceutical equivalence and a scientific bibliography on safety and efficacy assessment were submitted. compiled automatically

Daglyf® Duo preclinical

Report on preclinical studies of a generic medicinal product in the form of film-coated tablets. It contains information on the absence of own preclinical studies and the submission of study results of the reference product in accordance with legal requirements. compiled automatically

Tiara A® updated

Preclinical study report and clinical trial report of a generic medicinal product in the form of film-coated tablets. Contains the justification for the absence of preclinical studies and the results of a bioequivalence study involving healthy volunteers. compiled automatically

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РАЛІНА_29

МЕТИЛПРЕДНІЗОЛОН-ФАРМАК_30