Truberzi

Medicinal product

(Invented) name

Truberzi

Active substance (s)

Eluksadolinas

Strength

100 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A07DA06, Eluxadoline

Marketing authorisation holder

Allergan Pharmaceuticals International Ltd., Airija

Date of authorisation

2016-09-19

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

Film-coated tablet	1 vnt.
Eluksadolinas	100 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
66546	81081	1081081	lizdinė plokštelė	N56		Receptinis	EU/1/16/1126/003	Netiekiama	-	-	No	-	-
66547	81082	1081082	lizdinė plokštelė	N28		Receptinis	EU/1/16/1126/004	Netiekiama	-	-	No	-	-
99252	85358	1085358	lizdinė plokštelė	N168 (3x56) (sudėtinė)		Receptinis	EU/1/16/1126/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-01-05	Išregistruotas
2016-09-19	Registruotas