Search the database for deliberate release of GM medicinal products

Displaying 1 - 7 of 7
EU record number Title Company / Sponsor Treated organism Genetic modification
B/BE/21/BVW9 Dossier withdrawn by the notifier ActoGenix Humans V181 is a live attenuated dengue quadrivalent vaccine rDENVΔ30 where the four viral components of V181 (one for each serotype) present a deletion of 30 nucleotides in the 3’ non‐coding region (Δ30)
B/BE/21/BVW2 Phase I study to assess safety, tolerability and immunogenicity of the hRVFV-4s vaccine in healthy subjects Wageningen Bioveterinary Research (Larissa Consortium) Humans hRVFV-4s is a four segments human Rift Valley fever virus vaccine, which derives from a natural clone (Clone 13) that lacks 69% of the gene NSs, a major virulence determinant of the virus. The hRVFV-4s vaccine is further attenuated by splitting the M genome segment into two M-type segments.
Only notified under the "contained use" procedure. Dossier submitted on 07/04/2014. A single-center, open-label Phase 1 study to assess safety and medical endoscopic sampling methodology and to characterize the pharmacokinetics of oral doses of AG014 in Healthy Subjects ActoGenix Humans gene expressing certolizumab
Only notified under the "contained use" procedure. Dossier submitted on 08/05/2012. A single-center, open-label Phase 1 study to assess the effect of food/beverage and to characterisze the pharmacokinetics of single and multiple oral doses of AG013 in Healthy Subjects ActoGenix Humans Human Trefoil Factor 1
Only notified under the "contained use" procedure. Dossier submitted on 23/04/2012. Randomized Phase III of haploidentical HCT with or without an add back strategy of HSV-Tk donor lymphocytes in patients with high risk acute leukemia Molmed S.p.A. Humans -Thymidine Kinase (HSV-Tk) - selection marker
Only notified under the "contained use" procedure. Dossier submitted on 11/07/2002. A European and Canadian multicenter, randomized, double-blind, placebo controlled study to evaluate the efficacy and safety of Ad5FGF-4 in patients with stable angina Schering N.V./S.A. Humans human FGF-4
B/BE/01/V6 Evaluation of efficacy of Salmonella Dublin-Typhimurium vaccine, double gene deleted avirulent live culture in calves. Pharmacia Animal health calves genetic modification of Salmonella enterica by deletion of 2 genes (ssaC and ssaT)