Pravafenix

Medicinal product

(Invented) name

Pravafenix

Active substance (s)

Pravastatinas/Fenofibratas

Strength

40 mg/160 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)

C10BA03, Pravastatin and fenofibrate

Marketing authorisation holder

LABORATOIRES SMB S.A, Belgija

Date of authorisation

2011-04-14

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

Capsules, hard	1 vnt.
Pravastatinas	40 mg
Fenofibratas	160 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
46086	59892	1059892	lizdinė plokštelė	N30		Receptinis	EU/1/11/679/001	Netiekiama	-	-	No	-	-
46087	59893	1059893	lizdinė plokštelė	N60		Receptinis	EU/1/11/679/002	Netiekiama	-	-	No	-	-
46088	59894	1059894	lizdinė plokštelė	N90		Receptinis	EU/1/11/679/003	Netiekiama	-	-	No	-	-
46089	59895	1059895	buteliukas	N30		Receptinis	EU/1/11/679/004	Netiekiama	-	-	No	-	-
46090	59896	1059896	buteliukas	N60		Receptinis	EU/1/11/679/005	Netiekiama	-	-	No	-	-
46091	59897	1059897	buteliukas	N90		Receptinis	EU/1/11/679/006	Netiekiama	-	-	No	-	-
53713	67696	1067696	buteliukas	N14		Receptinis	EU/1/11/679/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-04-14	Registruotas