Lantus

Medicinal product

(Invented) name

Lantus

Active substance (s)

Insulinas glarginas

Strength

100 V/ml

Pharmaceutical form

injekcinis tirpalas flakone

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A10AE04, Insulin glargine

Marketing authorisation holder

Sanofi-Aventis Deutschland GmbH, Vokietija

Date of authorisation

2000-06-09

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 in a vial	1 ml
Insulinas glarginas	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
2150	7795	1007795	flakonas	5 ml, N1		Receptinis	EU/1/00/134/001	Netiekiama	-	-	No	-	-
26788	29358	1029358	flakonas	5 ml, N2		Receptinis	EU/1/00/134/002	Netiekiama	-	-	No	-	-
26789	29359	1029359	flakonas	5 ml, N5		Receptinis	EU/1/00/134/003	Netiekiama	-	-	No	-	-
26790	29360	1029360	flakonas	5 ml, N10		Receptinis	EU/1/00/134/004	Netiekiama	-	-	No	-	-
26791	29361	1029361	flakonas	10 ml, N1		Receptinis	EU/1/00/134/012	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2000-06-09	Registruotas