Summary of opinion: Zinplava, 14/12/2023 Positive

On 14 December 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Zinplava.

Metadata
Provider: 
European Medicines AgencyEuropean Medicines Agency
URL: 
https://www.ema.europa.eu/en/medicines/human/variation/zinplavahttps://www.ema.europa.eu/en/medicines/human/variation/zinplava
Retrieved on: 
Domenica, Gennaio 14, 2024
Information
Tags: 
Clostridioides difficile infection, Medication package insert, Patient, CHMP, Bezlotoxumab, Civil service commission, European Commission, Clostridioides, Recurrence, CDI, Marketing, Committee, Pharmaceutical industry
Geotags: 
EUROPEAN UNION
Sommario
Key Points: 
  • On 14 December 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Zinplava.
  • The marketing authorisation holder for this medicinal product is Merck Sharp & Dohme B.V.
  • The CHMP adopted an extension to the existing indication to include treatment of paediatric patients from 1 to 18 years of age.
  • 1New text in bold, removed text as strikethrough
Copyright: 
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