EU Regulatory News Round Up: NSAIDs During Pregnancy, Estragole Excipients, ePIs

 
• By David Ridley
  
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CMDh receives applications to change how NSAIDs are recommended for use during pregnancy; HMPC warns against use of estragole-containing excipients in herbals; EMA adopts new EU common standard for electronic product information on medicines marketed within the region.

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Several national and European Union variation applications have been received to change the wording of the recommendation of the use of non-steroidal anti-inflammatory medicines during pregnancy, according to the minutes of the most recent meeting of the European Medicines Agency’s Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) on 25-27 January 2022.

The submissions are based on a recent US Food and Drug Administration recommendation to avoid the use of NSAIDs in...

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