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New EU Approvals

 
• By Neena Brizmohun

Ten new products including Spark Therapeutics' gene therapy for treating patients with an inherited retinal disease, Luxturna, have been added to the Pink Sheet’s 2018 list of EU centralized approvals of new active substances. The list includes brand name, generic name, company, therapeutic category/indication, date of marketing authorization and product type (e.g., medicine, vaccine, biologic).

Luxturna (voretigene neparvovec) and Jivi (damoctocog alfa pegol) are among the ten new additions to the Pink Sheet's regularly updated listing of products containing new active substances that have been approved for marketing in the EU under the centralized authorization procedure in 2018. The other eight new additions are Takhzyro (lanadelumab), Alunbrig (brigatinib), Poteligeo (mogamulizumab), Delstrigo (doravirine/lamivudine/ tenofovir disoproxil), Vabomere (meropenem/vaborbactam), Emgality (galcanezumab), Pifeltro (doravirine) and Symkevi (tezacaftor/ivacaftor).

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