05.04.2024 - European Commission final decision

With the publication of the European Commission's decision, the risk assessment procedure according to Article 31 of Directive 2001/83/EC on medicinal products containing pseudoephedrine has been completed.

26.01.2024 - CHMP opinion

EMA’s human medicines committee (CHMP) endorsed the measures recommended by the Pharmacovigilance Risk Assessment Committee (PRAC) to minimise the risks of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) for medicines containing pseudoephedrine.

01.12.2023 - PRAC recommendation

PRAC recommends measures to minimise the risk of serious side effects with medicines containing pseudoephedrine.

EMA’s safety committee, PRAC, has recommended new measures for medicines containing pseudoephedrine to minimise the risks of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).

13.02.23 - procedure started

EMA’s safety committee (PRAC) has started a review of medicines containing pseudoephedrine following concerns about the risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), conditions affecting blood vessels in the brain. Pseudoephedrine is taken by mouth and is used alone or in combination with other medicines to treat nasal congestion (a blocked nose) resulting from a cold, flu or allergy.

Further information

For details on the procedure please click on the following link to the homepage of the European Medicines Agency (EMA):

Pseudoephedrine-containing medicinal products