Sevelamer Synthon

Medicinal product

(Invented) name

Sevelamer Synthon

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

Synthon BV, Nyderlandai

Date of authorisation

2014-09-04

Date of renewal

2022-10-24

Documents

3613_pakuotes lapelis_2022-10-24.docx

3613_Sevelamer Synthon_perr2022-10-24.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

DK/H/1948/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje 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
41550	55310	1055310	buteliukas	N180		Receptinis	LT/1/14/3613/001	Netiekiama	-	-	No	-	-
41551	55311	1055311	buteliukas	N200		Receptinis	LT/1/14/3613/002	Netiekiama	-	-	No	-	-
41552	55312	1055312	buteliukas	N210		Receptinis	LT/1/14/3613/003	Netiekiama	-	-	No	-	-
59971	74242	1074242	buteliukas	N360 (2x180)		Receptinis	LT/1/14/3613/004	Netiekiama	-	-	No	-	-
59972	74243	1074243	buteliukas	N400 (2x200)		Receptinis	LT/1/14/3613/005	Netiekiama	-	-	No	-	-
59973	74244	1074244	buteliukas	N420 (2x210)		Receptinis	LT/1/14/3613/006	Netiekiama	-	-	No	-	-
59974	74245	1074245	buteliukas	N540 (3x180)		Receptinis	LT/1/14/3613/007	Netiekiama	-	-	No	-	-
59975	74246	1074246	buteliukas	N600 (3x200)		Receptinis	LT/1/14/3613/008	Netiekiama	-	-	No	-	-
59976	74247	1074247	buteliukas	N630 (3x210)		Receptinis	LT/1/14/3613/009	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-07-07	Išregistruotas
2022-10-24	Perregistruotas
2014-09-04	Registruotas