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
26827	29395	1029395	užpildytas švirkštiklis	3 ml N1 (InnoLet)		Receptinis	EU/1/04/278/007	Netiekiama	-	-	No	-	-
26828	29396	1029396	užpildytas švirkštiklis	3 ml N5 (InnoLet)		Receptinis	EU/1/04/278/008	Netiekiama	-	-	No	-	-
26829	29397	1029397	užpildytas švirkštiklis	3 ml N10 (InnoLet)		Receptinis	EU/1/04/278/009	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2004-06-01	Registruotas