Truberzi

Medicinal product

(Invented) name

Truberzi

Active substance (s)

Eluksadolinas

Strength

75 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	75 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
66544	81079	1081079	lizdinė plokštelė	N56		Receptinis	EU/1/16/1126/001	Netiekiama	-	-	No	-	-
66545	81080	1081080	lizdinė plokštelė	N28		Receptinis	EU/1/16/1126/002	Netiekiama	-	-	No	-	-
99251	85357	1085357	lizdinė plokštelė	N168 (3x56) (sudėtinė)		Receptinis	EU/1/16/1126/005	Netiekiama	-	-	No	-	-

Stadijos

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