PharmacovigilanceOfficial

EMA reviews Rifadin liquid rifampicin over diethanolamine excipient; no reformulation proposed

🇪🇺 EMA · Thu 15 Oct 2026

The CHMP is assessing whether Rifadin 20 mg/ml oral suspension and syrup should stay on the EU market, as its marketing authorisation holder has not proposed a diethanolamine-free formulation.

EMA's human medicines committee, the CHMP, has begun an Article 31 review of Rifadin 20 mg/ml oral suspension and syrup, a liquid formulation of the antibiotic rifampicin. The procedure started on 25 June 2026 and is listed as under evaluation. The Dutch medicines agency (MEB) requested the review.

At issue is the excipient diethanolamine (DEA). According to EMA, it helps keep the active substance evenly distributed in the liquid and maintains the acidity needed for stability and tolerability. DEA is classified as a possible carcinogen on the basis of long-term rodent studies at very high doses. EMA notes that these doses were far above what people would normally receive from medicines containing DEA, but says long-term exposure above certain levels may raise the risk of some cancers.

The review follows a 2019 request from the CMDh, the group representing EU member states plus Iceland, Liechtenstein and Norway for nationally authorised products. It asked marketing authorisation holders to assess DEA-related risks and either remove the ingredient or justify why it could not be replaced. EMA says the company marketing this Rifadin formulation has not yet submitted a proposal for a DEA-free version.

The CHMP will now weigh the effect on the product's benefit-risk balance and recommend whether the authorisation should be maintained, amended, suspended or revoked. Its opinion goes to the European Commission, which issues a legally binding decision for all EU member states. The scope is limited to this one formulation, which is used mainly in children. Other rifampicin medicines and Rifadin forms, including capsules and infusion powder, are not part of the review.

The product is authorised in Austria, France, Ireland, Italy, the Netherlands, Northern Ireland, Portugal and Spain. It is sold as Rifoldin in Austria, Rifadine in France and Rifaldin in Spain. EMA advises patients and carers with questions to speak to a doctor or pharmacist and not to stop or change treatment without medical advice. The timetable page was last updated on 15 October 2026.

What it means for your team

  • Marketing authorisation holders and national agencies should check whether the Rifadin 20 mg/ml liquid, including Rifoldin, Rifadine and Rifaldin, is on their portfolio or market and watch the CHMP timetable.
  • The outcome could range from maintaining the authorisation to revoking it, with supply implications for a paediatric tuberculosis formulation in eight markets.
  • Companies with other DEA-containing products should note that the 2019 CMDh request to reformulate or justify the excipient remains the benchmark regulators are applying.
  • Pharmacovigilance and communications teams should be ready for patient and carer queries, since EMA's advice is not to stop or change treatment without medical advice.

Official source: EMA ↗

Article written by VigiEye from the official source (EMA). AI-assisted; check the source before acting.

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