REPORTS on preclinical studies and clinical trials

Daglyph® Duo clinical part I

05.10.2026 391

Clinical trial report on the bioequivalence of the generic medicinal product dapagliflozin/metformin hydrochloride 5 mg/1000 mg in the form of film-coated tablets, manufactured by PJSC Farmak. The study was conducted with the participation of healthy volunteers under fasting conditions to confirm bioequivalence to the reference product. generated automatically

KOLKHIMED_preclinical

05.10.2026 314

Preclinical study report of a medicinal product submitted as an annex to the registration materials. Contains data on pharmacology, pharmacokinetics and toxicology; for a generic product, preclinical studies are not required. compiled automatically

KOLKHIMED_clinical

05.10.2026 285

Report on a clinical trial of a medicinal product in the form of a solution for injection submitted for state registration. Contains data on the applicant, the manufacturer, justification for the absence of bioequivalence studies for the generic product and a conclusion. compiled automatically

LENVATINIB-VISTA

05.10.2026 291

Report on preclinical and clinical studies of the generic medicinal product in the form of hard capsules. Contains justification for the absence of preclinical studies and the results of an open-label randomised crossover bioequivalence study involving healthy male volunteers. compiled automatically

OZLAM

05.10.2026 268

Report on preclinical studies and report on a clinical trial of the generic medicinal product apremilast in tablet form. Contains a review of preclinical data based on scientific literature and the results of a bioequivalence study. compiled automatically

ADERMIX

05.10.2026 312

Report on preclinical studies of a hybrid medicinal product, stating that no own toxicological and pharmacological tests were conducted and none are required. It also contains a clinical trial report indicating the applicant, manufacturers and information on the studies conducted. compiled automatically

AIGLIP-PHARMAK_preclinical

05.10.2026 287

Preclinical study report of a generic medicinal product in tablet form developed as a generic of the reference product. No own preclinical studies were conducted; instead, the results of studies of the reference product are provided. compiled automatically

AIGLIP-PHARMAK_clinic

05.10.2026 267

Clinical trial report of a generic medicinal product containing data on the proof of bioequivalence, design, inclusion criteria, efficacy and safety results. Intended for specialists who evaluate registration materials. compiled automatically

APIXABAN GEDEON RICHTER

05.10.2026 269

Preclinical study report and clinical bioequivalence trial report of a generic medicinal product based on apixaban in tablet form. The document contains a review of pharmacological, pharmacokinetic and toxicological data, as well as the results of a bioequivalence study with the comparator product. compiled automatically

EMBOX_ preclinical

05.10.2026 262

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