Levemir

Medicinal product

(Invented) name

Levemir

Active substance (s)

Insulinas detemiras

Strength

100 TV/ml

Pharmaceutical form

injekcinis tirpalas užpildytame švirkštiklyje

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A10AE05, Insulin detemir

Marketing authorisation holder

Novo Nordisk A/S, Danija

Date of authorisation

2004-06-01

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	1 ml
Insulinas detemiras	100 TV

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
50256	64133	1064133	užpildytas švirkštiklis	3 ml N1 (FlexTouch)		Receptinis	EU/1/04/278/012	Netiekiama	-	-	No	-	-
50257	64134	1064134	užpildytas švirkštiklis	3 ml N5 (FlexTouch)		Receptinis	EU/1/04/278/013	Netiekiama	-	-	No	-	-
50258	64135	1064135	užpildytas švirkštiklis	3 ml N2x5 (FlexTouch)		Receptinis	EU/1/04/278/014	Netiekiama	-	-	No	-	-
50259	64136	1064136	užpildytas švirkštiklis	3 ml N1 (FlexTouch,7 NovoFine adatos)		Receptinis	EU/1/04/278/015	Netiekiama	-	-	No	-	-
50260	64137	1064137	užpildytas švirkštiklis	3 ml N1 (FlexTouch, 7 NovoTwist adatos)		Receptinis	EU/1/04/278/016	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2004-06-01	Registruotas