Teduglutide Viatris

Medicinal product

(Invented) name

Teduglutide Viatris

Active substance (s)

Tedugliutidas

Strength

5 mg

Pharmaceutical form

milteliai ir tirpiklis injekciniam tirpalui

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A16AX08, Teduglutide

Marketing authorisation holder

Viatris Limited, Airija

Date of authorisation

2026-01-08

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Flakone yra	1 vnt.
Tedugliutidas	5 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
119586	105692	1105692	flakonas	milteliai, tirpiklio užpildytas švirkštas (0,5 ml), N28		Receptinis	EU/1/25/2005/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2026-01-08	Registruotas