Kolbam

Medicinal product

(Invented) name

Kolbam

Active substance (s)

Cholio rūgštis

Strength

50 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A05AA03, Cholic acid

Marketing authorisation holder

Retrophin Europe Limited, Airija

Date of authorisation

2014-04-04

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

Hard capsules	1 vnt.
Cholio rūgštis	50 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
58938	73156	1073156	buteliukas	N90		Receptinis	EU/1/13/895/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-07-13	Išregistruotas
2014-04-04	Registruotas