Insulin glargine

Key facts

Invented name
Lantus
Active substance
insulin glargine
Therapeutic area
Endocrinology, -gynacology-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)
Diabetes mellitus
Route(s) of administration
Subcutaneous use
Contact for public enquiries
Applicant: 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

Decision

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