TRANSLARNA

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

Active ingredients

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

1 Ataluren UNII K16AME9I3V - ATALUREN

A nonsense mutation in DNA results in a premature stop codon within an mRNA. This premature stop codon in the mRNA causes disease by terminating translation before a full-length protein is generated. Ataluren enables ribosomal readthrough of mRNA containing such a premature stop codon, resulting in production of a full-length protein. Read about Ataluren

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
TRANSLARNA Granules for oral suspension	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
M09AX03		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 M09AX03

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): 586020050000307, 586020050000407, 586020050000507
Country: EE	Ravimiamet	Identifier(s): 1660890, 1660902, 1660913
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 407747, 439045, 515244
Country: FR	Base de données publique des médicaments	Identifier(s): 65945882, 67503464, 68469328
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 329001, 329015, 329374
Country: IE	Health Products Regulatory Authority	Identifier(s): 88946, 88948, 88949
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 7636, 7637, 7638
Country: IT	Agenzia del Farmaco	Identifier(s): 043535018, 043535020, 043535032
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1074021, 1074022, 1074023
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 143103, 143111, 143138
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100325791, 100325800, 100325816
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W62138001, W62139001, W62140001