Biltricide - supply shortage
Ongoing
praziquantel
Shortage
Human
Shortage information
There is a shortage of Biltricide in the European Union/European Economic Area (EU/EEA).
Biltricide contains the active substance praziquantel and is used for the treatment of infections caused by trematodes (parasitic worms).
The company informed EMA that it is no longer able to manufacture Biltricide for commercial reasons and will stop marketing the medicine. This has led to a shortage of Biltricide in the EU.
The shortage is not related to a quality defect of the product or a safety issue.
The shortage affects all Member States where the product is marketed: Germany, France and the Netherlands. Other countries that import Biltricide are also affected.
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 holder to mitigate the impact of the supply shortage.
The SPOC Working Party supports the MSSG and monitors and reports events that could affect the supply of medicines in the EU.
- The company that markets Biltricide is no longer able to manufacture Biltricide for commercial reasons and will stop marketing the medicine in the EU. This has led to a shortage of the medicine in the EU.
- For patients with a trematode infection other than schistosomiasis, healthcare professionals should consider alternative treatment options.
- For patients with schistosomiasis, there is no other effective treatment available in the EU. Healthcare professionals should consult local or national guidelines on how to manage these patients.
- For additional information consult your country’s shortage register or contact your national competent authority.
- The company that markets Biltricide, a medicine used to treat certain parasitic (worm) infections, is no longer able to manufacture Biltricide for commercial reasons and will stop marketing the medicine in the EU.
- Other treatments are available for most parasitic infections; your doctor will discuss with you the best alternative treatment option.
- There is no treatment alternative for schistosomiasis in the EU; your doctor will manage your condition in line with relevant guidelines.
- 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
- Biltricide
- Supply shortage status
- Ongoing
- International non-proprietary name (INN) or common name
- praziquantel
- Therapeutic area (MESH)
- Trematode Infections
- Strengths affected
- 600 mg film-coated tablets
- Availability of alternatives
- Yes
Key dates
- Start of supply shortage
- First published