Apidra

Medicinal product

(Invented) name

Apidra

Active substance (s)

Insulinas glulizinas

Strength

100 V/ml

Pharmaceutical form

injekcinis tirpalas flakone

Route (s) of administration

leisti į veną, leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A10AB06, Insulin glulisine

Marketing authorisation holder

Sanofi-Aventis Deutschland GmbH, Vokietija

Date of authorisation

2004-09-27

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 glulizinas	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
108998	95104	1095104	flakonas	10 ml N1		Receptinis	EU/1/04/285/001	Netiekiama	-	-	No	-	-
108999	95105	1095105	flakonas	10 ml N2		Receptinis	EU/1/04/285/002	Netiekiama	-	-	No	-	-
109000	95106	1095106	flakonas	10 ml N4		Receptinis	EU/1/04/285/003	Netiekiama	-	-	No	-	-
109001	95107	1095107	flakonas	10 ml N5		Receptinis	EU/1/04/285/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2004-09-27	Registruotas