Analysis of the decisions of foreign regulatory authorities

Abstract

Analysis of recommendations of foreign regulatory authorities on the restriction of circulation of medicines and/or the need for changes in the instructions for their medical use due to changes in the safety profile, conducted by experts of the Scientific Centre for Expert Evaluation of Medicinal Products revealed 25 administrative decisions of foreign regulatory authorities. These decisions contained information on the following medicines registered in Russia: apixaban, granulocyte-macrophage colony stimulating factor, hydroxyethyl starch, dabigatran, eltrombopag, epoetin alfa, atypical antipsychotic drugs, benzocaine, varenicline, carbamazepine, lamotrigine, suvorexant, topiramate, aztreonam, azithromycin, isoniazid, caspofungin, miconazole, meropenem, atazanavir, dolutegravir, lamivudine, efavirenz.

Keywords

• adverse reactions
• postmarketing studies
• safety profile
• drugs
• instructions for medical use
• pharmacovigilance