Mimpara - supply shortage
Ongoing
cinacalcet
Shortage
Human
Shortage information
There is a shortage of Mimpara in some EU Member States.
Mimpara is a medicine used to treat:
- secondary hyperparathyroidism (overactive parathyroid glands) in adults and children aged 3 years and older with serious kidney disease who need dialysis (to clear their blood of waste products);
- hypercalcaemia (high blood calcium levels) in adults with cancer of the parathyroid glands, or with primary hyperparathyroidism when the parathyroid glands cannot be removed.
Mimpara is available as tablets and as granules in capsules for opening. The tablets can be used by adults and children who need doses of 30 mg or more and are able to swallow tablets. The granules in capsules for opening are used in younger children and in patients with difficulty swallowing.
For further information on the use of the medicine, please refer to the medicine’s overview page.
The company for Mimpara, Amgen, has decided to stop marketing all strengths of Mimpara tablets and granules in capsules for opening in the EU due to commercial reasons. This decision is not related to a quality defect or safety issue. The timeline for the discontinuation varies between Member States and discontinuation has either taken effect or will take effect between March and September 2025.
For tablets:
- Member States where discontinuation occurred in June 2024: Austria, Croatia, Cyprus, Germany, Ireland, Italy, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Spain and France;
- Member States where discontinuation is planned in March 2025: Greece and Hungary;
- Member States where discontinuation is planned in September 2025: Belgium and Slovenia.
For granules in capsules for opening:
- Member States where discontinuation is planned in March 2025: Croatia, Czechia, Germany, Ireland, Netherlands and Portugal;
- Member State where discontinuation is planned in September 2025: France;
- Member States where discontinuation will occur either when available supplies are depleted or in September 2025, whichever comes first: Slovenia and Spain.
For up-to-date information about the status of a medicine shortage in a particular Member State, consult the national shortage register or contact the national competent authority.
EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) and Medicines Shortages Single Point of Contact (SPOC) Working Party are closely monitoring the supply situation and engaging with the marketing authorisation holder to mitigate the impact of the supply shortage.
- The company that markets Mimpara in the EU has decided to stop marketing all strengths of Mimpara tablets and granules in capsules for opening due to commercial reasons;
- The date of discontinuation varies by Member State, as mentioned above;
- Before initiating treatment with Mimpara, check with your national competent authority in case they have issued national recommendations;
- Switch existing patients to an alternative treatment, taking into account the following information:
- different generic versions of cinacalcet tablets are available; however, there is no generic of cinacalcet granules in capsules for opening;
- Etelcalcetide (Parsabiv) is authorised for adults with secondary hyperparathyroidism and chronic kidney disease on haemodialysis. Etelcalcetide should not be initiated in patients until 7 days after the last dose of cinacalcet and the corrected serum calcium is at or above the lower limit of the normal range;
- treatment alternatives may differ across Member States.
- A medicine shortage communication (MSC) has been sent to healthcare professionals in affected Member States.
- For additional information, consult your country’s shortage register or contact your national competent authority.
- The company that markets Mimpara in the EU has decided to stop marketing all strengths of Mimpara tablets and granules in capsules for opening due to commercial reasons;
- The date of discontinuation varies by Member State, as mentioned above;
- If you or your child are being treated with Mimpara, your doctor will recommend a different treatment;
- Contact your pharmacy or doctor well before your or your child’s supply of the medicine runs out;
- If you have any questions, speak to your or your child’s doctor or pharmacist.
- For additional information, consult your country’s shortage register or contact your national competent authority.
Key facts
- Medicines affected
- Mimpara
- Supply shortage status
- Ongoing
- International non-proprietary name (INN) or common name
- cinacalcet
- Therapeutic area (MESH)
- Hypercalcemia
- Parathyroid Neoplasms
- Hyperparathyroidism
- Pharmaceutical forms affected
- Tablet
- Granules in capsule
- Strengths affected
- 30, 60, 90mg (tablets)
- 1, 2.5, 5mg (granules in capsule)
- Availability of alternatives
- Yes
Key dates
- First published