Creon - supply shortage
Ongoing
pancreas powder
pancrelipase
ShortageHuman
Shortage information
Creon (also marketed as Kreon in certain Member States) contains pancreas enzymes (lipase / amylase / protease) and is used to treat pancreatic exocrine insufficiency (a condition in which the pancreas insufficiently delivers digestive enzymes into the small intestine, thereby preventing food from being fully digested) resulting from other conditions or ageing.
The company that produces Creon is experiencing limitations in production capacity. Coupled with a high demand, this has led to intermittent shortages in the supply of Creon hard capsules. The shortages are not related to a quality defect of the product or a safety issue.
Production capacity limitations are expected to be resolved in the second half of 2026. Until then, periodic shortages in the supply of Creon are anticipated.
The shortage affects some of the Member States where the product is marketed: Austria, Belgium, Bulgaria, Cyprus, Czechia, France, Greece, Italy, Ireland, Latvia, Luxembourg, Malta, Netherlands, Portugal, Spain and Sweden.
This information may change. For up-to-date information about the status of a medicine shortage in a particular EU/EEA Member State, consult the national shortage register or contact the national competent authority.
EMA’s SPOC working party is closely monitoring the supply situation and engaging with the marketing authorisation holder, alternative marketing authorisation holders and national authorities to identify measures to mitigate the impact of the supply shortage.
The SPOC working party is responsible for monitoring and reporting events that could affect the supply of medicines in the EU.
- Limitations in manufacturing capacity, combined with a high demand, have resulted in intermittent shortages in the supply of Creon hard capsules. The supply of Creon granules is not affected.
- The products are authorised for the treatment of pancreatic exocrine insufficiency caused by cystic fibrosis or other conditions and the treatment of pancreatic exocrine insufficiency in the elderly.
- Healthcare professionals are asked to limit prescription to the authorised indications, at the minimum effective dose, for patients already under treatment for whom it is not possible to switch to alternative. If available and appropriate, patients currently on treatment can be switched to a suitable alternative or lower dosage.
- For additional information consult your country’s shortage register or contact your national competent authority.
- Limitations in manufacturing capacity, combined with a high demand, have resulted in periodic shortages in the supply of Creon hard capsules. There is no supply shortage of Creon granules.
- These products are used to treat pancreatic exocrine insufficiency.
- Your doctor has been asked to limit prescribing these products to safeguard their availability for patients.
- If you are using Creon capsules, your doctor may prescribe a lower dose or switch you to a suitable alternative.
- If you have any questions, speak to your doctor or pharmacist.
- For additional information, consult your country’s shortage register or contact your national competent authority.
Key facts
- Medicines affected
- Creon
- Supply shortage status
- Ongoing
- International non-proprietary name (INN) or common name
- pancreas powder
- pancrelipase
- Therapeutic area (MESH)
- Pancreatic Diseases
- Pharmaceutical forms affected
- Capsule, hard
- Strengths affected
- 10,000 units
- 25,000 units
- 35,000 units
- Availability of alternatives
- Yes
Key dates
- Expected resolution
- Second half of 2026
- First published