Austedo

Medicinal product

(Invented) name

Austedo

Active substance (s)

Deutetrabenazinas

Strength

12 mg+24 mg+30 mg/36 mg+42 mg+48 mg

Pharmaceutical form

pailginto atpalaidavimo tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N07XX16, deutetrabenazine

Marketing authorisation holder

Teva GmbH, Vokietija

Date of authorisation

2026-01-08

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Tabletėje (1-6 savaitei) yra:	1 vnt.
Deutetrabenazinas	12 mg+24 mg+30 mg/36 mg+42 mg+48 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
119598	105704	1105704	lizdinė plokštelė	N1 (N21 (7×12 mg, 7×24 mg, 7×30 mg) + N21 (7×36 mg, 7×42 mg, 7×48 mg))	pakuotė gydymui pradėti	Receptinis	EU/1/25/1956/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2026-01-08	Registruotas