Article 107i referrals

Referral due to safety issues (Article 107i referrals)

This type of procedure is triggered when a EU Member State varied, suspended or revoked the marketing authorisation for a medicine in its territory because of a safety issue. The Co-ordination Group for Mutual Recognition and Decentralised Procedures-Humans (CHMPh) has completed a review of new data on the safety of oral formulations of moxifloxacin that is authorised in all Member States, via the Mutual Recognition or National Procedure and has concluded that the use of these drugs should be restricted for the treatment of acute bacterial sinusitis, acute exacerbation of chronic bronchitis and community-acquired pneumonia. In October 2007, the assessment of the Periodic Safety Update Report (PSUR) for moxifloxacin identified major safety concerns including life threatening hepatotoxicity cases. Additionally, cardiac toxicity including QTc interval prolongation, severe skin reactions, Clostridium difficile associated colitis, tendon and muscular toxicity (including rhabdomyolysis) are important identified risks and under close monitoring.

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