EVRYSDI

This brand name is authorized in United States. It is also authorized in Brazil, Croatia, Ecuador, Estonia, Finland, Hong Kong SAR China, Ireland, Israel, Japan, Lithuania, New Zealand, Poland, Romania, Spain, UK.

Active ingredients

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

1
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 more about Risdiplam

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 EVRYSDI Powder for oral solution MPI, EU: SmPC European Medicines Agency (EU)
 EVRYSDI Oral solution MPI, US: SPL/PLR FDA, National Drug Code (US)

Medicine classification

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

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

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