Medicinal products for human use (centralised procedure, red = withdrawn / not authorised, to show remove filter from column 'authorised'; * = calculated or derived column; 'orphan', 'conditional' and 'paediatric indication 4.1' = current status, may change or may have changed. Indications by presentation are separated by ' / '.) Perl regular expressions can be used, e.g. ^(?!.*diabetes).*$ to filter out diabetes. While re-ordering columns, do not use a filter.

Imposed post-authorisation studies (specific obligation in case of a medicinal product with a conditional marketing authorisation, efficacy [PAES] or safety [PASS] study). Note there can be many errors due to information extraction: missing studies, erroneous descriptions, wrong due dates. Also note that completed studies are no more extractable.

Assessment reports (initial or extension of indication) and Summary of Product Characteristics (SmPCs) can be searched for any text. Paragraphs of the reports are listed as context, with a link to the document. Clicking on 'View' opens the document at the concerned page (and, in Firefox, with the search expression highlighted). The search is case-independent. Since May 2021, text in images is also searchable (temporarily unavailable end September 2021). Further information on how to compose search expressions is here . Note that a two-stage search can be done, first with the expression in the box below and second with the filters in the column heads.

Enter an expression and click 'Search...' to go through the full text and images of all reports (PDF files) in this webapp at this time (see 'About').

Across all human medicinal products, this table holds all procedural steps after authorisation, extracted from corresponding PDF files in the products' EPARs. calculated or derived columns: 'indicator' = CMA2MA, ExC2MA, PaedData, PaedIndic, PIPcompleted for corresponding content, 'view_ar' to open corresponding assessment report. Only authorised medicinal products are shown. Note there can be errors due to issues with linkage across sources and due to extraction errors: missing procedures, erroneous summaries, wrong dates.

Click and copy the URL as a permanent bookmark of the current state of the Product list in the app (search, filters, column visibility).

Click to remove filters and searches, and to restore the default column visibility.

Summary

Contents

This webapp shows information that is extracted from web pages made publicly available by the European Medicines Agency (EMA) on their website. The information in this webapp is updated automatically and on a daily basis. EMA EPARs can be found under this link. Withdrawn applications may not be included in this webapp, but all can be found under this link.

Credits and disclaimer

The European Medicines Agency (EMA) is acknowledged as a source of information used in this webapp and should always be acknowledged by users. Consult the European Medicines Agency copyright and limited reproduction notices here. The correctness of information shown in this webapp is not verified and the information is not guaranteed to be correct. Extraction of information from PDF files and web pages (such as the indication column) is error-prone, and the information should be used cautiously. Users have the responsibility to verify the information they use.

The U.S. National Library of Medicine (NLM) is acknowledged as the source of the Medical Subject Headings (MeSH) Resource Data Framework (RDF). The MeSH API has been used to identify root terms of EMA therapeutic area terms.

Author and citation

Comments are welcome in blog here

Data in webapp

  • selected information from all EPAR web pages
  • indication and post-authorisation studies from SmPC PDF files
  • fulltext of assessment PDF files
  • procedural steps after authorisation
  • calculated: MeSH root term, paediatric indication

Webapp

  • 2018-10-31 initial release
  • 2019-06-11 generate MeSH trees and root terms for each medicine (see new column)
  • 2019-06-21 improve user interface functions and bookmarking
  • 2019-08-31 more indications from PDF, MeSH
  • 2019-09-14 adding imposed post-authorisation studies
  • 2019-11-17 adding calculating paediatric indication (in testing; uses section 4.1 information)
  • 2019-12-03 enable regex filtering on empty columns
  • 2020-02-20 only show indications from SmPC PDF
  • 2020-03-14 speed up
  • 2020-05-10 fix indication extraction
  • 2020-05-17 improved paediatric indication detection
  • 2020-09-09 adding fulltext assessment report query
  • 2020-09-26 state now authorised, withdrawn, suspended, refused
  • 2021-04-22 fix when several SmPCs are found for one product
  • 2021-05-04 delete remnants renamed products
  • 2021-05-04 start OCRing images in PDF files (2021-09-25 temporarily disabled)
  • 2021-05-17 correct indexing PDF files (tab “Assessment analysis”)
  • 2021-09-14 correct MeSH root term finding
  • 2021-10-03 new: steps after authorisation (further functions in the works)