Lantus

Medicinal product

(Invented) name

Lantus

Active substance (s)

Insulinas glarginas

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)

A10AE04, Insulin glargine

Marketing authorisation holder

Sanofi-Aventis Deutschland GmbH, Vokietija

Date of authorisation

2001-02-06

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 pre-filled pen (SoloStar)	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
26812	29382	1029382	užpildytas švirkštiklis	3 ml N1 (SoloStar)		Receptinis	EU/1/00/134/030	Netiekiama	-	-	No	-	-
26813	29383	1029383	užpildytas švirkštiklis	3 ml N3 (SoloStar)		Receptinis	EU/1/00/134/031	Netiekiama	-	-	No	-	-
26814	29384	1029384	užpildytas švirkštiklis	3 ml N4 (SoloStar)		Receptinis	EU/1/00/134/032	Netiekiama	-	-	No	-	-
26815	4814	1004814	užpildytas švirkštiklis	3 ml N5 (SoloStar)		Receptinis	EU/1/00/134/033	Tiekiama	-	-	No	-	-
26816	29385	1029385	užpildytas švirkštiklis	3 ml N6 (SoloStar)		Receptinis	EU/1/00/134/034	Netiekiama	-	-	No	-	-
26817	29386	1029386	užpildytas švirkštiklis	3 ml N8 (SoloStar)		Receptinis	EU/1/00/134/035	Netiekiama	-	-	No	-	-
26818	29387	1029387	užpildytas švirkštiklis	3 ml N9 (SoloStar)		Receptinis	EU/1/00/134/036	Netiekiama	-	-	No	-	-
26819	29388	1029388	užpildytas švirkštiklis	3 ml N10 (SoloStar)		Receptinis	EU/1/00/134/037	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2001-02-06	Registruotas