Registered antibiotics for tuberculosis in EU/EEA countries and UK
This spreadsheet contains an extract of the Article 57 database received from EMA with information up to July 27, 2025. This may be helpful for those individuals procuring antibiotic for tuberculosis to better understand which products are marketed, where they are marketed, under which regulatory pathway, and the contact information for the marketing authorization holder.
Please note that the terms below apply:
- The information provided is based on data held in the Article 57 database. This data is submitted by holders of marketing authorisations (MAHs) for medicines in the European Union and the European Economic Area. The provided data reflects the state of the Article 57 database on 27 July 2025 as extracted on 28 July 2025.
- A medicinal product may contain multiple pharmaceutical products (administrable pharmaceutical forms), e.g. tablets and film-coated tablets, or tablets with different compositions as part of a same medicinal product. These forms are listed in sequence and separated by a “|” sign.
- MAHs must submit information to the European Medicines Agency (EMA) on authorised medicines and keep this information up-to-date in accordance with EU pharmaceutical regulation.
- The following Guidance can be consulted for more information on how and when Article 57 data elements are to be populated: Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the European Medicines Agency in accordance with Article 57(2) of Regulation (EC) No. 726/2004, Chapter 3.II: XEVPRM User Guidance.
- Further information on the Article 57 database can be found here.