Shortage of Apidra (insulin glulisine) cartridges Spain

The European Medicines Agency is aware of a shortage of Apidra, a medicine for treating diabetes, affecting the supply of Apidra 3 ml cartridges and Apidra prefilled disposable pens (OptiSet and SoloStar) in several EU Member States.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) has made several recommendations to manage the situation and ensure patients continue to receive appropriate treatment during the temporary supply shortage.

What is Apidra?
Apidra is a solution for injection that contains the active substance insulin glulisine. It is used to treat
patients aged six years or over with diabetes, when they need insulin.

What is the cause of the supply problem and how long will it last?
The company that markets Apidra, Sanofi-Aventis Deutschland GmbH, informed the Agency that an accidental spillage occurred on 11 July 2011 at the plant where the medicine is manufactured in Frankfurt, Germany. Manufacturing has been temporarily suspended while internal investigations are taking place. This will result in a continued delay in the release of batches of Apidra cartridges onto the EU market. The shortage affects Apidra cartridges and Apidra prefilled disposable pens, OptiSet and SoloStar. It does not affect Apidra vials or any other Sanofi insulin product (Lantus and Insuman).

Normal supply is expected to resume in early 2012. Supply shortages are expected in most EU Member States until normal supply resumes.

Statement from the European Medicines Agency regarding the supply of Apidra from Sanofi.

Problemas temporales de Apidra España: Este articluo en Español/This article in Spanish


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