Topamax

The company for Topamax is experiencing manufacturing problems. A routine assessment at a manufacturing site identified the need to modify engineering controls and internal environmental technologies, resulting in a temporary interruption of production. 

This has led to a shortage of Topamax tablets. The shortage is not related to a quality defect of the product or a safety issue.

The shortage is expected to last until the end of 2026.

The shortage affects all Member States where the product is marketed (Austria, Belgium, Croatia, Cyprus, Germany, Hungary, Italy, Netherlands, Portugal, Spain).

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 using the below links.

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. 

In addition, the company has drafted a plan to ensure equitable distribution of Topamax tablets between markets, based on criteria such as unmet medical need and market share.

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 an ongoing shortage of Topamax tablets in the EU/EEA, which is expected to last until the end of 2026.
• Available stock should be prioritised for existing patients who are already established on Topamax tablets and for new patients for whom no suitable therapeutic alternatives are available.
• For new patients or if Topamax tablets are not available, consider prescribing a different medicine or formulation. Depending on the indication and the patient's age, these may include, but are not limited to:
  • Other topiramate formulations (generic topiramate tablets, topiramate capsules or topiramate oral solutions). 
  • Other medicines that are currently approved for the same indications and patient groups.
• A medicine shortage communication (MSC) has been sent to healthcare professionals in affected Member States and will also be published on the EMA website.
• For additional information consult your country’s shortage register or contact your national competent authority.

• There is an ongoing shortage of Topamax tablets in the EU/EEA, which is expected to last until the end of 2026.
• If Topamax tablets are not available, your doctor will discuss with you alternatives such as switching to a different topiramate medicine (such as generic topiramate tablets, capsules or oral solution), or to another medicine authorised to treat your condition. 
• 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 using the below links.