Ucedane

Medicinal product

(Invented) name

Ucedane

Active substance (s)

Karglumo rūgštis

Strength

200 mg

Pharmaceutical form

disperguojamosios tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A16AA05, Carglumic acid

Marketing authorisation holder

Eurocept International B. V., Nyderlandai

Date of authorisation

2017-06-23

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Dispersible tablet	1 vnt.
Karglumo rūgštis	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
68626	83208	1083208	lizdinė plokštelė	N60		Receptinis	EU/1/17/1202/001	Netiekiama	-	-	No	-	-
102198	88299	1088299	lizdinė plokštelė	N12		Receptinis	EU/1/17/1202/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-06-23	Registruotas