Levemir

Medicinal product

(Invented) name

Levemir

Active substance (s)

Insulinas detemiras

Strength

100 V/ml

Pharmaceutical form

injekcinis tirpalas užtaise

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
26821	29390	1029390	užtaisas	3 ml N1 (Penfill)		Receptinis	EU/1/04/278/001	Netiekiama	-	-	No	-	-
26822	29391	1029391	užtaisas	3 ml N5 (Penfill)		Receptinis	EU/1/04/278/002	Netiekiama	-	-	No	-	-
26823	29392	1029392	užtaisas	3 ml N10 (Penfill)		Receptinis	EU/1/04/278/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2004-06-01	Registruotas