Xultophy

Medicinal product

(Invented) name

Xultophy

Active substance (s)

Insulinas degludekas/Liragliutidas

Strength

100 V/3,6 mg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A10AE56, Insulin degludec and liraglutide

Marketing authorisation holder

Novo Nordisk A/S, Danija

Date of authorisation

2014-09-18

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10b

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection	1 ml
Insulinas degludekas	100 V
Liragliutidas	3,6 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
60224	74498	1074498	užpildytas švirkštiklis	3 ml N1		Receptinis	EU/1/14/947/001	Netiekiama	-	-	No	-	-
60225	74499	1074499	užpildytas švirkštiklis	3 ml N3		Receptinis	EU/1/14/947/002	Netiekiama	-	-	No	-	-
60226	74500	1074500	užpildytas švirkštiklis	3 ml N5		Receptinis	EU/1/14/947/003	Netiekiama	-	-	No	-	-
60227	74501	1074501	užpildytas švirkštiklis	3 ml N10 (2x5)		Receptinis	EU/1/14/947/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-09-18	Registruotas