REPORTS on preclinical studies and clinical trials

Daglyph® Duo clinical part I

05.10.2026 74

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

AIGLIP-PHARMAK_clinic

05.10.2026 26

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 32

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

KOLKHIMED_preclinical

05.10.2026 44

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 35

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 35

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 33

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 35

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 40

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

Daglyf® Duo preclinical

05.10.2026 23

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