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ISARALGAGÉN CIVAPARVOVEC
A NON-REPLICATING ADENO-ASSOCIATED VIRAL VECTOR ENCODING CODON-OPTIMISED HUMAN ALPHA-GALACTOSIDASE A (GLA). A RECOMBINANT, NON-REPLICATING ADENO-ASSOCIATED VIRAL VECTOR SEROTYPE 6 (AAV6) ENCODING CODON-OPTIMISED HUMAN ALPHA-GALACTOSIDASE A (GLA) UNDER CONTROL OF LIVER-SPECIFIC REGULATORY ELEMENTS [COMPRISING ENHANCER AND HEPATIC CONTROL REGION FROM THE HUMAN APOLIPOPROTEIN E (APOE) GENE, THE HUMAN ALPHA-1- ANTITRYPSIN (HAAT) PROMOTER, A CHIMERIC HUMAN BETA- GLOBIN/IGG (HBB-IGG) INTRON, AS WELL AS A WPREMUT6 REGION] AND A BOVINE GROWTH HORMONE (BGH) POLY A SEQUENCE, FLANKED BY ADENO-ASSOCIATED VIRUS 2 (AAV2) INVERTED TERMINAL REPEATS; PROPOSED INN: LIST 124, RECOMMENDED INN: LIST 86