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818 results

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Information Letter on Spiolto Respimat: Possibly defective dose indicator PDF, 105KB, File does not meet accessibility standards Date: 01. March 2024 Topics: Pharmakovigilanz Type: Risk information

Active substance: tiotropium bromide/olodaterol hydrochloride

The company Boehringer Ingelheim Pharma GmbH & Co. KG informs about possibly defective dose indicators in two batches of the medicinal product Spiolto Respimat 2.5 micrograms/2.5 micrograms.

Direct Healthcare Professional Communication (DHPC) on combined hormonal contraceptives with chlormadinone acetate/ethinyl estradiol: Slightly increased risk of venous thromboembolism PDF, 401KB, File is accessible Date: 23. February 2024 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: chlormadinone acetate, ethinyl estradiol

The marketing authorization holders of combined hormonal contraceptives containing chlormadinone acetate and ethinyl estradiol provide information about a slightly increased risk of venous thromboembolism.

Direct Healthcare Professional Communication (DHPC) on valproate-containing medicines: potential risk of neurodevelopmental disorders in children of fathers treated with valproate PDF, 955KB, File is accessible Date: 19. February 2024 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: valproate

The marketing authorisation holders of valproate-containing medicinal products would like to inform you about new measures regarding an increased risk of neurodevelopmental disorders in children born to men treated with valproate.

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.

Direct Healthcare Professional Communication (DHPC) on pseudoephedrine: risks of posterior reversible encephalopathy syndrome and reversible cerebral vasoconstriction syndrome Date: 15. February 2024 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pseudoephedrine

Few cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported with the use of pseudoephedrine-containing medicinal products.

Valproate: Potential risk of neurodevelopmental disorders in children born to men treated with valproate medicines Date: 26. January 2024 Topics: Pharmakovigilanz Type: Risk information

Active substance: valproate

The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) endorsed precautionary measures recommended by EMA’s safety committee (PRAC) for the treatment of male patients with valproate medicines.

Valproate: Potential risk of neurodevelopmental disorders in children born to men treated with valproate medicines Date: 12. January 2024 Topics: Pharmakovigilanz Type: Risk information

Active substance: valproate

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recommends precautionary measures for the treatment of male patients with valproate-containing medicinal products.

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

Information Letter on Leqvio 284 mg solution for injection in a pre-filled syringe: Important information regarding instructions for use before injection PDF, 1MB, File is accessible Date: 21. December 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Inclisiran

The company Novartis informs about difficulties in moving the syringe plunger resulting in the inability to inject Leqvio.

Direct Healthcare Professional Communication (DHPC) on miltefosine (Impavido 10 mg/50 mg capsules): Updated warning on ocular changes, including keratitis PDF, 325KB, File is accessible Date: 14. December 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: miltefosine

The company Paesel und Lorei GmbH & Co. KG informs about an updated warning regarding ocular changes.