TRANSLARNA

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

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 more about Ataluren

Medication package inserts

Below package inserts are available for further reading:

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