Renagel

Medicinal product

(Invented) name

Renagel

Active substance (s)

Sevelameras

Strength

800 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)

V03AE02, Sevelamer

Marketing authorisation holder

Sanofi Winthrop Industrie, Prancūzija

Date of authorisation

2001-04-23

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

Kapsulėje yra:	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
28120	30656	1030656	buteliukas	N180		Receptinis	EU/1/99/123/008	Netiekiama	-	-	No	-	-
28121	30657	1030657	buteliukas	N180×2		Receptinis	EU/1/99/123/009	Netiekiama	-	-	No	-	-
28122	30658	1030658	buteliukas	N180×3		Receptinis	EU/1/99/123/010	Netiekiama	-	-	No	-	-
28123	30659	1030659	buteliukas	N100		Receptinis	EU/1/99/123/011	Netiekiama	-	-	No	-	-
28124	30660	1030660	buteliukas	N1x180 (be išorinės pakuotės)		Receptinis	EU/1/99/123/012	Netiekiama	-	-	No	-	-
36937	50549	1050549	buteliukas	N6x30 (su išorine pakuotė)		Receptinis	EU/1/99/123/013	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2001-04-23	Registruotas