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Ocaliva: Review of the risk-benefit ratio Date: 09. December 2024 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: obeticholic acid

On 26 November 2024, the General Court dismissed the action for interim measures, which means that the revocation decision for Ocaliva has now taken effect.

Pseudoephedrine: Risks of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) Date: 04. April 2024 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: pseudoephedrine

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.

Contrast agents containing gadolinium: Deposits in the brain and other tissues Date: 16. February 2024 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: gadolinium

For contrast agents containing gadolinium, the suspension of marketing authorisations has been extended until 28 February 2026.

Valproate: Risk of congenital malformations and developmental problems associated with use during pregnancy Date: 12. January 2024 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: valproate

Educational material on medicinal products containing valproate