Lyxumia

Medicinal product

(Invented) name

Lyxumia

Active substance (s)

Liksizenatidas+Liksizenatidas

Strength

10 µg + 20 µg

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A10BJ03, lixisenatide

Marketing authorisation holder

Sanofi Winthrop Industrie, Prancūzija

Date of authorisation

2013-02-01

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

Solution for injection (10 µg)	3 ml
Liksizenatidas	10 µg
Solution for injection (20 µg)	3 ml
Liksizenatidas	20 µg

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
55308	69356	1069356	užpildytas švirkštiklis	3 ml (14 dozių) N1 (10 µg) + 3 ml (14 dozių) N1 (20 µg)	pakuotė gydymui pradėti	Receptinis	EU/1/12/811/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-02-01	Registruotas