Cerezyme - supply shortage

Shortage resolved

imiglucerase

Shortage information

The shortage affecting Cerezyme has been resolved and the information and recommendations which were issued during the shortage no longer apply.

Reason for shortage

The supply shortage of Cerezyme began in June 2009 and was caused by a series of manufacturing problems at one of its manufacturing sites.

Member States affected

All European Union (EU) Member States

Information for healthcare professionals

• Stock levels are continuing to improve, however the product supply remains vulnerable to disruption.
• Based on current stock levels, patients currently treated with Cerezyme can receive the full dose recommended in the summary of product characteristics.
• Healthcare professionals who wish to start new patients should contact the company prior to starting treatment. New patients can be started as long as existing stocks are sufficient.
• Additional advice may be available from the national competent authority.

Information for patients

• Stock levels are continuing to improve, however the product supply remains vulnerable to disruption.
• For patients who are currently being treated with Cerezyme, the treating doctor will now be able to prescribe the full dose.
• New patients may now be able to receive Cerezyme.
• Patients who have any questions should speak to their doctor or pharmacist.
• Additional advice may be available from the national competent authority.
• Patients may also contact Eurordis, an organisation representing people with rare diseases in Europe.

Key facts

• Medicines affected:
  Cerezyme
• Supply shortage status:
  Shortage resolved
• International non-proprietary name (INN) or common name:
  imiglucerase
• Therapeutic area (MESH):
  Gaucher Disease
• Pharmaceutical forms affected:
  Solution for infusion
• Availability of alternatives:
  No

Key dates

• First published:
  04/11/2013
• Last updated:
  01/10/2018