Cholib

Medicinal product

(Invented) name

Cholib

Active substance (s)

Fenofibratas/Simvastatinas

Strength

145 mg/20 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)

C10BA04, Simvastatin and fenofibrate

Marketing authorisation holder

Viatris Healthcare Limited, Airija

Date of authorisation

2013-08-26

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10b

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Film-coated tablet	1 vnt.
Fenofibratas	145 mg
Simvastatinas	20 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
57057	71169	1071169	lizdinė plokštelė	N10		Receptinis	EU/1/13/866/001	Netiekiama	-	-	No	-	-
57058	71170	1071170	lizdinė plokštelė	N30		Receptinis	EU/1/13/866/002	Netiekiama	-	-	No	-	-
60869	75159	1075159	lizdinė plokštelė	N90		Receptinis	EU/1/13/866/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-08-26	Registruotas