Renvela

Medicinal product

(Invented) name

Renvela

Active substance (s)

Sevelameras

Strength

0,8 g

Pharmaceutical form

milteliai geriamajai suspensijai

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

Powder for oral suspension	1 vnt.
Sevelameras	0,8 g

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
100230	86339	1086339	paketėlis	N90		Receptinis	EU/1/09/521/008	Netiekiama	-	-	No	-	-
102199	88300	1088300	paketėlis	N90 (su dozavimo šaukštu)		Receptinis	EU/1/09/521/009	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-06-10	Registruotas