Orphacol

Medicinal product

(Invented) name

Orphacol

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

THERAVIA, Prancūzija

Date of authorisation

2013-09-12

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10a

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
57104	71217	1071217	lizdinė plokštelė	N30		Receptinis	EU/1/13/870/001	Netiekiama	-	-	No	-	-
57105	71218	1071218	lizdinė plokštelė	N60		Receptinis	EU/1/13/870/002	Netiekiama	-	-	No	-	-
57106	71219	1071219	lizdinė plokštelė	N120		Receptinis	EU/1/13/870/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-09-12	Registruotas