Insulin glargine

Adopted

First published: 16/09/2009
Last updated: 16/09/2009
EMEA/387927/2009

Invented name	Lantus
Active substance	insulin glargine
Therapeutic area	Endocrinology-Gynaecology-Fertility-Metabolism
Decision number	P/133/2009
PIP number	Insulin glargine
Pharmaceutical form(s)	Solution for injection Solution for injection in a vial Solution for injection in a cartridge
Condition(s) / indication(s)	Treatment of type I diabetes mellitus Treatment of type II diabetes mellitus
Route(s) of administration	Subcutaneous use
Contact for public enquiries	Sanofi-Aventis Deutschland GmbH E-mail: sylvie.gabriel@sanofi-aventis.com Country: France Phone: + 33 153774152 Fax: 33 153774133
Decision type	P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Compliance procedure number	EMEA-C-000387-PIP01-08
Compliance opinion date	18/11/2011
Compliance outcome	positive