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Pharmacogenomic information in drug labels: European Medicines Agency perspective

The Pharmacogenomics Journal volume 15, pages 201–210 (2015)Cite this article

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Abstract

Pharmacogenomics (PGx) has a growing impact on healthcare and constitutes one of the major pillars of personalised medicine. For the purpose of improved individualised drug treatment, there is an increasing effort to develop drugs suitable for specific subpopulations and to incorporate pharmacogenomic drug labels in existing and novel medicines. Here, we review the pharmacogenomic drug labels of all 517 medicinal products centrally approved in the European Union (EU) since the establishment of the European Medicines Agency in 1995. We identified all pharmacogenomic-related information mentioned in the product labels and classified it according to its main effect and function on drug treatment, that is, metabolism, transport and pharmacodynamics, and according to the place of the respective section of the Summary of Product Characteristics (SmPC). The labels are preferentially present in drugs having antineoplastic properties. We find that the number of drugs with pharmacogenomic labels in EU increases now steadily and that it will be an important task for the future to refine the legislation on how this information should be utilised for improvement of drug therapy.

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Author information

Authors and Affiliations

  1. European Medicines Agency, Pharmacogenomics Working Party, London, UK

    F Ehmann, L Caneva & M Papaluca-Amati

  2. Pharmacogenomics Working Party—European Medicines Agency (EMA), London, UK

    K Prasad, M Paulmichl, M Maliepaard & A Llerena

  3. Medicines and Healthcare products Regulatory Agency (MHRA), London, UK

    K Prasad

  4. Paracelsus Medical University, Salzburg, Austria

    M Paulmichl

  5. Medicines Evaluation Board,, Utrecht,, The Netherlands

    M Maliepaard

  6. Radboud University Nijmegen Medical Center,,

    M Maliepaard

  7. Nijmegen,, The Netherlands

    M Maliepaard

  8. Extremadura University Hospital, Faculty of Medicine, Clinical Research Center, Badajoz,, Spain

    A Llerena

  9. Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden

    M Ingelman-Sundberg

Authors
  1. F Ehmann
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  2. L Caneva
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  3. K Prasad
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  4. M Paulmichl
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  5. M Maliepaard
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  6. A Llerena
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  7. M Ingelman-Sundberg
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  8. M Papaluca-Amati
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Corresponding author

Correspondence to F Ehmann.

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The views expressed in this article are the personal views of the author(s) and may not be understood or quoted as being made on behalf of or reflecting the position of the European Medicines Agency or one of its Committees or Working Parties.

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Ehmann, F., Caneva, L., Prasad, K. et al. Pharmacogenomic information in drug labels: European Medicines Agency perspective. Pharmacogenomics J 15, 201–210 (2015). https://doi.org/10.1038/tpj.2014.86

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