The Ministry of Health of the Russian Federation has registered the medicinal product “Oxybuprocaine eye drops 0.4%” produced by FSUE Moscow Endocrine Plant. Marketing authorisation No. LP-004942, registration date 20/07/2018.
The medicinal product belongs to topical anesthetics pharmacotherapeutic group and is the first generic of the medicinal product with the INN - oxybuprocaine.
The product is on the the Vital and Essential Drugs List (VED).
Indications for the use of the medicinal product are:
- local anaesthesia in Ophthalmology (including topical anaesthesia of cornea and conjunctiva);
- tonometry;
- gonioscopy and other diagnostic examinations before subconjunctival injections;
- foreign body and seam removal from cornea and conjunctiva;
- short-term surgical interventions on cornea and conjunctiva;
The medicinal product is recommended for administration in children since 2 years of age.
Efficiency and safety profile has been approved in comparative studies with the medicinal product “Inocaine®, eye drops 0.4 %”.
The project was implemented as part of the import substitution program in accordance with the departmental plan of import substitution events in the pharmaceutical industry field of the Russian Federation approved by the Order of the Ministry of Industry and Trade of Russia No. 656 dd. March 31, 2015.
Comment type is not specified in the component properties.