Renvela

Medicinal product

(Invented) name

Renvela

Active substance (s)

Sevelameras

Strength

800 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)

V03AE02, Sevelamer

Marketing authorisation holder

Sanofi Winthrop Industrie, Prancūzija

Date of authorisation

2009-06-10

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

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.
Sevelameras	800 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
36946	50558	1050558	buteliukas	N30		Receptinis	EU/1/09/521/001	Netiekiama	-	-	No	-	-
36947	50559	1050559	buteliukas	N6x30		Receptinis	EU/1/09/521/002	Netiekiama	-	-	No	-	-
36948	50560	1050560	buteliukas	N180 (be išorinės pakuotės)		Receptinis	EU/1/09/521/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-06-10	Registruotas