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
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. |
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 |
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 | |
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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