EVRYSDI

This brand name is authorized in Brazil, Ecuador, Estonia, Spain, Finland, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, New Zealand, Poland, Romania, United Kingdom, United States

Active ingredients

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

1 Risdiplam
UNII 76RS4S2ET1 - RISDIPLAM

Risdiplam is a survival of motor neuron 2 (SMN2) pre-mRNA splicing modifier designed to treat SMA caused by mutations of the SMN1 gene in chromosome 5q that lead to SMN protein deficiency. Functional SMN protein deficiency is directly linked to the SMA pathophysiology which includes progressive loss of motor neurons and muscle weakness. Risdiplam treats SMA by increasing and sustaining functional SMN protein levels.

Read about Risdiplam

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
EVRYSDI Oral solution FDA, National Drug Code (US) MPI, US: SPL/PLR
EVRYSDI Powder for oral solution 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
M09AX10 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 M09AX10

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): 529221030027002
Country: EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria Identifier(s): 6376-MEE-0621
Country: EE Ravimiamet Identifier(s): 1845446
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 1211531001
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 573248
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 397636
Country: HK Department of Health Drug Office Identifier(s): 67230
Country: IL מִשְׂרַד הַבְּרִיאוּת Identifier(s): 8768
Country: JP 医薬品医療機器総合機構 Identifier(s): 1190029R1028
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1092319
Country: NZ Medicines and Medical Devices Safety Authority Identifier(s): 21894
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100450142
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): W67547001
Country: US FDA, National Drug Code Identifier(s): 50242-175

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