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Mandatory update of class risk effect of corticosteroids in Product Information of EU

8 Feb

Mandatory update of class risk effect of corticosteroids in Product Information of EU

After the CMDh meeting last month and following the recommendations of PRAC, the products containing the following active substances will have to perform an update on their PIL:

  • budesonide
  • misoprostol (gynaecological indication – labour induction)
  • moxifloxacin (systemic use)
  • nadifloxacin
  • nefopam
  • nicardipine
  • sulprostone
  • treprostinil

PRAC considered that “Blurred Vision” and “Central Serous Chorioretinopathy” is a class risk effect of corticosteroids and should also be included in the product information of the fixed combinations of budesonide as well as other corticosteroids, for all routes of administration. The MAHs of affected products should take due note of the outcome and implement this PRAC recommendation via the appropriate regulatory procedures. Further information regarding the above mentioned will be published on the EMA website.