ZOLGENSMA

This brand name is authorized in Austria, Brazil, Estonia, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Poland, Romania, United Kingdom

Active ingredients

The drug ZOLGENSMA contains one active pharmaceutical ingredient (API):

1 Onasemnogene abeparvovec UNII MLU3LU3EVV - ONASEMNOGENE ABEPARVOVEC

Onasemnogene abeparvovec is a gene therapy designed to introduce a functional copy of the survival motor neuron gene (SMN1) in the transduced cells to address the monogenic root cause of the disease. By providing an alternative source of SMN protein expression in motor neurons, it is expected to promote the survival and function of transduced motor neurons. Read about Onasemnogene abeparvovec

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
ZOLGENSMA Solution for infusion	European Medicines Agency (EU)	MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
M09AX09		M Musculo-skeletal system → M09 Other drugs for disorders of the musculo-skeletal system → M09A Other drugs for disorders of the musculo-skeletal system → M09AX Other drugs for disorders of the musculo-skeletal system
Discover more medicines within M09AX09

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 526520120096607, 526520120096707, 526520120096807, 526520120097007, 526520120097107, 526520120097207, 526520120097307, 526520120097407, 526520120097507, 526520120097607, 526520120097707, 526520120097807, 526520120097907, 526520120098007, 526520120098107, 526520120098207, 526520120098307, 526520120098407, 526520120098507, 526520120098607, 526520120098707, 526520120098807
Country: EE	Ravimiamet	Identifier(s): 1818749, 1818750
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 030057, 071699, 075726, 080295, 095567, 099041, 117487, 119712, 125008, 153358, 156260, 159179, 162256, 180580, 197840, 379399, 382728, 388856, 400842, 404246, 417225, 431308, 439396, 474942, 486229, 495553, 508660, 517512, 529102, 533282, 536123, 541531, 546520, 571189, 581654, 582886, 584075
Country: FR	Base de données publique des médicaments	Identifier(s): 69200149
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 395864, 395867, 395870, 395873, 395878, 395879, 395882, 395885, 395888, 395891, 395894, 395897, 395900, 395903, 395906, 395909, 395912, 395915, 395918, 395921, 395924, 395930, 395935, 395940, 395942, 395946, 395949, 395952, 395955, 395960, 395962, 395970, 395992, 396002, 396005, 396010, 396013
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 8558
Country: IT	Agenzia del Farmaco	Identifier(s): 048773016, 048773028, 048773030, 048773042, 048773055, 048773067, 048773079, 048773081, 048773093, 048773105, 048773117, 048773129, 048773131, 048773143, 048773156, 048773168, 048773170, 048773182, 048773194, 048773206, 048773218, 048773220, 048773232, 048773244, 048773257, 048773269, 048773271, 048773283, 048773295, 048773307, 048773319, 048773321, 048773333, 048773345, 048773358, 048773360, 048773372
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1090199, 1090200, 1090201, 1090202, 1090203, 1090204, 1090205, 1090206, 1090207, 1090273, 1090274, 1090275, 1090276, 1090277, 1090279, 1090280, 1090281, 1090282, 1090283, 1090284, 1090285, 1090286, 1090287, 1090288, 1090289, 1090290, 1090291, 1090292, 1090293, 1090294, 1090295, 1090296, 1090297, 1090298, 1090299, 1090300, 1090301
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100439135
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W69208001, W69208002, W69208003, W69208004, W69208005, W69208006, W69208007, W69208008, W69208009, W69208010, W69208011, W69208012, W69208013, W69208014, W69208015, W69208016, W69208017, W69208018, W69208019, W69208020, W69208021, W69208022, W69208023, W69208024, W69208025, W69208026, W69208027, W69208028, W69208029, W69208030, W69208031, W69208032, W69208033, W69208034, W69208035, W69208036, W69208037