Luxembourg's Ministry of Health has announced that, following the decision of the European Commission in the context of arbitration concerning the reassessment of marketing authorisations based on bioequivalence studies conducted by GVK Bio Company in India, the suspension of authorisations of 700 medicinal products in Europe is being enforced.
In Luxembourg, one of these drugs was marketed with two dosages, Esomeprazole Mylan 20 mg gastro-resistant capsules and Esomeprazole Mylan 40 mg gastro-resistant capsules. A second drug with three dosages, Repaglinide Mylan 0.5 mg tablets, Repaglinide Mylan 1 mg tablets and Repaglinide Mylan 2 mg tablets had been authorised but not yet marketed in Luxembourg.
The Ministry of Health had already decided in December 2014 as a precautionary measure, pending the decision by the European authorities, to suspend the marketing authorisations, Esomeprazole Mylan 20 mg gastro-resistant capsules and Esomeprazole Mylan 40 mg gastro-resistant capsules. As of 8 December 2014 a circular letter was sent to all pharmacists and hospitals, wholesale distributors of medicines, and to official bodies (CNS, Medical Control of Social Security), informing them of the suspension.
Similarly a press release informing of this suspension was issued on 11 December 2014.
Subsequently, on 20 August 2015, the Ministry of Health suspended the authorisations of non-marketed drugs Repaglinide Mylan 0.5 mg tablets, Repaglinide Mylan 1 mg tablets and Mylan Repaglinide 2 mg tablets.
