French Regulator At Odds With EMA Over Safety Restrictions For Pseudoephedrine
The product information for all pseudoephedrine-containing medicines in the EU will need to be updated, the European Medicines Agency said today.
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The French regulator says that the safety issues associated with pseudoephedrine-containing medicines, and the fact that they are indicated for "benign, non-life threatening and self-resolving conditions," calls their benefit-risk balance into question.
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