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Outcome of the 160th Session of the European Pharmacopoeia Commission

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European Pharmacopoeia
Ph. Eur. Commission
News
05 April 2018
Strasbourg, France

At its 160th Session which took place in Strasbourg on 20-21 March 2018, the European Pharmacopoeia (Ph. Eur.) Commission adopted 19 new monographs, 3 new chapters, 51 revised monographs and 15 revised chapters, including:

  • six monographs elaborated under the P4 procedure, Atazanavir sulfate (2898), Everolimus (2918), Fingolimod hydrochloride (2988), Deferiprone oral solution (2987), Lacosamide infusion (2991) and Lacosamide oral solution (2990). This procedure applies to substances still under patent protection;
  • a new monograph on Live biotherapeutic products for human use (3053), together with two general chapters (2.6.36 and 2.6.38) on the methods to control microbial contamination of these products. This will be the subject of a separate specific press release;
  • a revised General chapter on Infrared absorption spectrophotometry (2.2.24). A separate press-release will be published on this topic;
  • a revised version of the general monograph on Products of recombinant DNA technology (0784). This will be the subject of a separate specific press release.

All adopted texts ensure that the Ph. Eur. content is kept updated and in line with the latest regulatory developments and scientific state of the art; they will be effective on 1 April 2019 and will be published in Supplement 9.7 of the Ph. Eur.

 

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