ZOLGENSMA

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

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 more about Onasemnogene abeparvovec

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

ATC Group		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)
BR	Câmara de Regulação do Mercado de Medicamentos	526520120096607, 526520120096707, 526520120096807, 526520120097007, 526520120097107, 526520120097207, 526520120097307, 526520120097407, 526520120097507, 526520120097607, 526520120097707, 526520120097807, 526520120097907, 526520120098007, 526520120098107, 526520120098207, 526520120098307, 526520120098407, 526520120098507, 526520120098607, 526520120098707, 526520120098807
EE	Ravimiamet	1818749, 1818750
FI	Lääkealan turvallisuus- ja kehittämiskeskus	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
FR	Base de données publique des médicaments	69200149
GB	Medicines & Healthcare Products Regulatory Agency	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
IL	מִשְׂרַד הַבְּרִיאוּת	8558
IT	Agenzia del Farmaco	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
LT	Valstybinė vaistų kontrolės tarnyba	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
PL	Rejestru Produktów Leczniczych	100439135
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	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