The Ministry of Health of the Russian Federation has canceled the state registration of nine medicines and excluded them from the state register of medicines. These include:
– Nebolin® caps (ibuprofen), capsules 200 mg, 400 mg, manufactured by Marksans Pharma Limited (India). Nonsteroidal anti-inflammatory drug (NSAID);
– Desmopressin (demospressin), nasal spray, dosed 10 mcg/dose, produced by Inpak AS (Norway). A drug against diabetes insipidus;
– Opra (citalopram), film-coated tablets, 20 mg, 40 mg, manufactured by ACTAVIS h. f. (Iceland), MEDA Manufacturing GmbH (Germany), ZAO ZiO-Zdorovye (Russia). Antidepressant drug;
– Galantamine-Teva (galantamine), film-coated tablets, 4 mg, 8 mg, manufactured by Teva Pharmaceutical Industries Ltd. (Israel). Anti-Alzheimer’s drug;
– Neotigazon® (acitretin), capsules, 10 mg, 25 mg, manufactured by Pateon Inc. (Canada), F. Hoffman-La Roche Ltd.(Switzerland), Senexi (France), Roche Pharma AG (Germany). Tissue repair stimulator;
– Syndroxocin (doxorubicin), lyophilizate for the preparation of a solution
for intravascular and intravesical administration, 10 mg, 50 mg, produced by S. C. Sindan-Pharma S. R. L. (Romania), Actavis Italy S. P. A. (Italy). Antitumor antibiotic;
– Fosavance® Forte (alendronic acid + colecalciferol), tablets, 70 mg+140 mcg, manufactured by Merck Sharp & Dohme B.V. (the Netherlands). Bone resorption inhibitor used to treat osteoporosis;
– Para plus, an aerosol for external use produced by Laboratoires Omega Pharma France (France), Aeropharm (France). Combined drug against head lice;
– Nevirapine (nevirapine), tablets, 200 mg produced by AO R-Pharm (Russia). A drug for the treatment of HIV infection.
The decisions were made on the basis of the following:
– submission by the holder or owner of the registration certificate of a drug, or another legal entity authorized by the holder or owner, of an application for the cancellation of state registration of medicinal products;
– due to the fact that the state registration of the drug for human use was not confirmed based on the results of an examination of the quality of the drug and/or an evaluation of the expected benefit to possible risk ratio related to the use of the drug.