Back Outcome of the 161st Session of the European Pharmacopoeia Commission

EDQM Strasbourg, France 29/06/2018
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At its 161st Session, which took place in Strasbourg on 19-20 June 2018, the European Pharmacopoeia (Ph. Eur.) Commission adopted 10 new monographs, 1 new chapter, 92 revised monographs and 7 revised chapters; new texts include:

  • four monographs elaborated under the P4 procedure: Nilotinib hydrochloride monohydrate (2993), Regorafenib monohydrate (3012), Deferiprone tablets (2986) and Lacosamide tablets (2989). This procedure applies to products still under patent protection;
  • one monograph on a medicinal product containing a biotherapeutic active substance: Filgrastim injection (2848);
  • new monographs for Levofloxacin hemihydrate (2598), Mebeverine hydrochloride (2097), Meningococcal group A, C, Y, W135 (3066), Polyamide suture, sterile, in distributor for veterinary use (3083) and Ophiopogon japonicus root (3000);
  • one new chapter: Foam index (2.8.24).

All of the adopted texts help to ensure that the Ph. Eur. content is kept up to date and in line with the latest regulatory developments and scientific state of the art; they will be effective from 1 July 2019 and will be published in Supplement 9.8 of the Ph. Eur.