OCALIVA

Medicinal product

(Invented) name

OCALIVA

Active substance (s)

Obeticholio rūgštis

Strength

10 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)

A05AA04, Obeticholic acid

Marketing authorisation holder

ADVANZ PHARMA Limited, Airija

Date of authorisation

2016-12-12

Date of renewal

Documents

DHPC_OCALIVA.pdf

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.
Obeticholio rūgštis	10 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
67296	81845	1081845	buteliukas	N30		Receptinis	EU/1/16/1139/002	Tiekiama	-	-	No	-	-
98481	84584	1084584	buteliukas	N100		Receptinis	EU/1/16/1139/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-08-30	Išregistruotas
2016-12-12	Registruotas