Levemir

Medicinal product

(Invented) name

Levemir

Active substance (s)

Insulinas detemiras

Strength

100 V/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 V

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
26824	29393	1029393	užpildytas švirkštiklis	3 ml N1 (FlexPen)		Receptinis	EU/1/04/278/004	Netiekiama	-	-	No	-	-
26825	4369	1004369	užpildytas švirkštiklis	3 ml N5 (FlexPen)		Receptinis	EU/1/04/278/005	Tiekiama	-	-	No	-	-
26826	29394	1029394	užpildytas švirkštiklis	3 ml N10 (FlexPen)		Receptinis	EU/1/04/278/006	Netiekiama	-	-	No	-	-
40912	54649	1054649	užpildytas švirkštiklis	3 ml N1 (FlexPen,7 NovoFine adatos)		Receptinis	EU/1/04/278/010	Netiekiama	-	-	No	-	-
40913	54650	1054650	užpildytas švirkštiklis	3 ml N1 (FlexPen, 7 NovoTwist adatos)		Receptinis	EU/1/04/278/011	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2004-06-01	Registruotas