Insulin glargine - paediatric investigation plan

insulin glargine
PIPHuman

Key facts

Invented name
  • Lantus
  • 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)
Decision date
Compliance procedure number
EMEA-C-000387-PIP01-08
Compliance opinion date
Compliance outcome
Positive

Decision

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