Evaluation of the Effectiveness of Risk Minimisation Measures: A Joint PASS Survey among Health Care Professionals to Assess their Knowledge and Attitudes on Prescribing Conditions of Thiocolchicoside containing Medicinal Products for Systemic Use in France, Greece, Italy and Portugal

Thiocolchicoside (TCC) is a semi-synthetic sulfurated colchicoside derivative with a muscle relaxant pharmacological activity, used in the management of non-specific low back pain. TCC is indicated as adjuvant treatment of painful muscular contractures in acute spinal pathology, in adults and adolescents from 16 years onwards. The benefits of TCC containing medicinal products are recognised in clinical practice, and they are widely used by prescribers in the concerned Member States (see Annex 3). An Article 31 referral on thiocolchicoside-containing medicinal products for systemic use was initiated in February 2013. The CHMP has concerns with regard to the potential genotoxicity of thiocolchicoside-containing medicinal products for systemic use. Within the context of minimization measures as per European Commission decision dated 17 January 2014, including a Dear Healthcare Professional Communication, changes to the SmPC, Labelling and Package Leaflet. As per EMA request the present survey will be conducted in complement to a Joint Drug Utilization Study.