Kuvan

Medicinal product

(Invented) name

Kuvan

Active substance (s)

Sapropterino dihidrochloridas

Strength

100 mg

Pharmaceutical form

tirpinamosios tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A16AX07, Sapropterin

Marketing authorisation holder

BioMarin International Limited, Airija

Date of authorisation

2008-12-02

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

Soluble tablet	1 vnt.
Sapropterino dihidrochloridas	100 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
32943	35323	1035323	buteliukas	N30		Receptinis	EU/1/08/481/001	Netiekiama	-	-	No	-	-
32944	35324	1035324	buteliukas	N120		Receptinis	EU/1/08/481/002	Tiekiama	-	-	No	-	-
32945	35325	1035325	buteliukas	N240		Receptinis	EU/1/08/481/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2008-12-02	Registruotas