| Developers: | Nativa |
| Date of the premiere of the system: | 2018/09/25 |
| Branches: | Pharmaceutics, medicine, health care |
2018: Gozerelin in the form of a hypodermic implant
On September 25, 2018 the pharmaceutical company "Nativa" announced that it registered domestic medicine with the international non-proprietary name "Gozerelin" in the form of a hypodermic implant. Medicine with the trade name "Gozerelin-long" is intended for therapy of a number of oncological diseases. The pharmaceutical concern "Astrazeneka" was until recently only producer of medicine with this MNN in the territory of Russia.
Gozerelin is protivoopukhlevy hormonal means, a synthetic analog natural a hormone gonadotrophin-rileasing. Medicine is provided in the form of an implant for hypodermic introduction in a set with the syringe applicator with a protection gear. Medicine has the prolonged action and is used for suppression of production of sex hormones, in particular, at cancer therapy of a mammary gland and prostate gland. The biopolymer structure of an implant is split in the patient's organism, releasing active ingredient. The similar delivery mode of medicine in an organism is modern and more effective replacement of traditional course treatment with the tableted and injection dosage forms.
The Nativa LLC company conducted a comparative preclinical research of specific pharmacological activity of medicine with MNN gozerelin on dynamics of change of concentration of gonadotropny and sex hormones at large laboratory animals, a research of the general (sharp and subsharp) toxicity and possible local irritant action of medicine. And also multicenter open comparative randomized clinical trial of efficiency and safety of use of the medicines "Gozerelin-long", the capsule for hypodermic introduction of the prolonged action of 3.6 mg and "Zoladeks", the capsule for hypodermic introduction of the prolonged action of 3.6 mg at patients with the localized, locally-spread or metastatic prostate cancer is conducted. As a result of the conducted researches it was shown that pharmakodinamichesky effects of the developed medicine are equivalent to reference.
The industrial production of medicine is going to be adjusted on the partner contract platform of JSC Pharmstandard-Ufavita in 2018.
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