Translarna

Medicinal product

(Invented) name

Translarna

Active substance (s)

Atalurenas

Strength

1000 mg

Pharmaceutical form

granulės geriamajai suspensijai

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

M09AX03, Ataluren

Marketing authorisation holder

PTC Therapeutics International Limited, Airija

Date of authorisation

2014-07-31

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Granules for oral suspension	1 vnt.
Atalurenas	1000 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
59789	74023	1074023	paketėlis	N30		Receptinis	EU/1/13/902/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-03-28	Išregistruotas
2014-07-31	Registruotas