Paliperidone palmitate - supply shortage
Shortage ongoing
ShortageHuman
Shortage information
In some EU Member States, there are shortages of long-acting injectable paliperidone palmitate-containing medicines marketed by the following companies: Advanz Pharma (Amdipharm Limited), Adamed Pharma, Alter, Belupo, Biogaran, EGIS Pharmaceuticals PLC, Elpen, G.L. Pharma and Innovis Pharma.
These shortages may also impact availability of other long-acting injectable paliperidone palmitate-containing medicines in other countries.
Paliperidone palmitate-containing medicines are used for the maintenance treatment of schizophrenia in adults whose disease has already been stabilised on treatment with paliperidone or risperidone.
A manufacturing company, Pharmathen International, is experiencing manufacturing problems. This has led to a shortage of long-acting injectable paliperidone palmitate-containing medicines. The shortage is not related to a quality defect of the product or a safety issue.
The end date of the shortage is not yet known.
The shortage affects some of the Member States where the product from the impacted companies is marketed or where alternative products are in short supply.
This information may change. 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 EMA’s shortages working party (Medicines Shortages Single Point of Contact – SPOC - Working Party) are closely monitoring the supply situation and engaging with the marketing authorisation holders to mitigate the impact of the supply shortage.
The SPOC Working Party supports EMA’s MSSG and monitors and reports events that could affect the supply of medicines in the EU.
- There is a shortage of prolonged-release paliperidone palmitate-containing suspensions for injection in several EU Member States.
- The end date of the shortage is not yet known.
- You may need to consider alternative medicines for your patients.
- For additional information, consult your country’s shortage register or contact your national competent authority.
- You may also contact relevant healthcare professional organisations for further information. A list of European not-for-profit organisations EMA engages with can be found on the EMA website.
- There is a shortage of long-acting injectable paliperidone palmitate-containing medicines in several EU Member States.
- The end date of the shortage is not yet known.
- Your healthcare professional will advise you on what other medicines you can take if your usual medicine is not available. 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.
- You may also contact relevant patients’ organisations for further information or support. A list of European not-for-profit organisations that EMA engages with can be found on the EMA website.
Key facts
- Medicines affected
- Paliperidone palmitate
- Supply shortage status
- Shortage ongoing
- Therapeutic area (MESH)
- Schizophrenia
- Availability of alternatives
- Yes
Key dates
- First published