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Pharmacovigilance Characteristics and Activities within the First Cohort of EU Risk Management Plans (RMPs): Small Molecules vs. Biologicals

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References

  1. Committee for Medicinal Products for Human Use. Guideline on risk management systems for medicinal products for human use. London: European Medicines Agency, November 2005

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  2. Kessler M, Goldsmith D, Schellekens H. Immunogenicity of biopharmaceuticals. Nephrol Dial Transplant 2006;21 Suppl 5: v9–v12

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Authors and Affiliations

  1. Division of Pharmacoepidemiology and Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht, The Netherlands

    T. J. Giezen, A. K. Mantel-Teeuwisse, A. C. G. Egberts & H. G. M. Leufkens

  2. Medicines Evaluation Board, The Hague, The Netherlands

    T. J. Giezen, A. K. Mantel-Teeuwisse, S. M. J. M. Straus & H. G. M. Leufkens

  3. Clinical Pharmacy, University Medical Center Utrecht, Utrecht, The Netherlands

    A. C. G. Egberts

  4. Medical Products Agency, Stockholm, Sweden

    I. Persson

Authors
  1. T. J. Giezen
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  2. A. K. Mantel-Teeuwisse
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  3. S. M. J. M. Straus
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  4. A. C. G. Egberts
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  5. I. Persson
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  6. H. G. M. Leufkens
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Giezen, T.J., Mantel-Teeuwisse, A.K., Straus, S.M.J.M. et al. Pharmacovigilance Characteristics and Activities within the First Cohort of EU Risk Management Plans (RMPs): Small Molecules vs. Biologicals. Drug-Safety 31, 885 (2008). https://doi.org/10.2165/00002018-200831100-00031

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  • DOI: https://doi.org/10.2165/00002018-200831100-00031

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