Fyzoclad:

Withdrawal of the marketing authorisation application

adalimumab

Overview

On 5 December 2018, Pfizer Europe MA EEIG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Fyzoclad, for the treatment of a number of inflammatory diseases.

Key facts

Name
Fyzoclad
Product number
EMEA/H/C/005253
International non-proprietary name (INN) or common name
  • adalimumab
Active substance
  • adalimumab
Date of withdrawal
05/12/2018
Company making the application
Pfizer Europe MA EEIG
Withdrawal type
Initial authorisation

All documents

Related information on withdrawals

A question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the medicine at the time of the withdrawal of the application, and includes a link to the company's formal withdrawal letter (withdrawal letter Doc. type, leave the 'Author' in properties blank).

An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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