Tetmodis

Medicinal product

(Invented) name

Tetmodis

Active substance (s)

Tetrabenazinas

Strength

25 mg

Pharmaceutical form

tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N07XX06, Tetrabenazine

Marketing authorisation holder

AOP Orphan Pharmaceuticals GmbH, Austrija

Date of authorisation

2010-10-12

Date of renewal

2013-11-08

Documents

2189 Tetmodis II PL 2025 09 18.docx

2189 Pakuotės lapelis 2025 09 18.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

AT/H/0855/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Tetrabenazinas	25 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
29287	31787	1031787	tablečių talpyklė	N112		Receptinis	LT/1/10/2189/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-11-08	Perregistruotas
2010-10-12	Registruotas