Zurampic

Medicinal product

(Invented) name

Zurampic

Active substance (s)

Lesinuradas

Strength

200 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)

M04AB05, Lesinurad

Marketing authorisation holder

Grünenthal GmbH, Vokietija

Date of authorisation

2016-02-18

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

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.
Lesinuradas	200 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
65196	79696	1079696	lizdinė plokštelė	N10		Receptinis	EU/1/15/1080/001	Netiekiama	-	-	No	-	-
65197	79697	1079697	lizdinė plokštelė	N28		Receptinis	EU/1/15/1080/002	Netiekiama	-	-	No	-	-
65198	79698	1079698	lizdinė plokštelė	N30		Receptinis	EU/1/15/1080/003	Netiekiama	-	-	No	-	-
65199	79699	1079699	lizdinė plokštelė	N98		Receptinis	EU/1/15/1080/004	Netiekiama	-	-	No	-	-
65200	79700	1079700	lizdinė plokštelė	N100x1		Receptinis	EU/1/15/1080/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-07-31	Išregistruotas
2016-02-18	Registruotas