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Dear Doctor Letter (Rote-Hand-Brief) on new contraindications of Saccharomyces boulardii (Saccharomyces cerevisiae HANSEN CBS 5926) in seriously ill or immunocompromised patients Date: 22. January 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Saccharomyces boulardii

The marketing authorisation holders of the medicinal products concerned issue information on rare cases of fungemia that led to death in seriously ill patients.

Information Letter on noradrenaline PDF, 3MB, File is accessible Date: 17. January 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: noradrenaline

The company Aguettant issues information on the marketing of a solution for infusion containing noradrenaline in two new ready-for-use strengths.

Information Letter on Haldol® (tablets, oral drops, solution, solution for injection) and Haldol Decanoat Depot®: clarification regarding Janssen-Cilag GmbH's Dear Doctor Letter of 21 December 2017 PDF, 261KB, File is accessible Date: 15. January 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: haloperidol

Due to questions regarding the recently circulated Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing haloperidol, the company Janssen-Cilag GmbH (Haldol®-Janssen) would like to clarify the aspects raised most frequently.

Dear Doctor Letter (Rote-Hand-Brief) on contrast media containing gadolinium: updated recommendations for use PDF, 388KB, File is accessible Date: 10. January 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: gadolinium

The marketing authorisation holders concerned are circulating information on indications confirmed by the European Medicines Agency (EMA) regarding low levels of gadolinium deposition in the brain following administration of contrast media …

Dear Doctor Letter (Rote-Hand-Brief) on Haldol® and Haldol Decanoat Depot® (haloperidol): changes in the indications and posology PDF, 689KB, File is accessible Date: 22. December 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: haloperidol

The company Janssen-Cilag wishes to inform that the European Medicines Agency (EMA) has conducted a procedure to harmonise the SmPCs, labelling and package leaflets of preparations containing haloperidol.

Dear Doctor Letter (Rote-Hand-Brief) on Eligard® (leuprorelin acetate): medication errors due to overtightening of the safety needle PDF, 559KB, File is accessible Date: 14. December 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: leuprorelin acetate

The company Astellas is circulating information on medication errors reported in connection with leakage of the medicinal product from the syringe..

Dear Doctor Letter (Rote-Hand-Brief) on Radium 223 dichloride (Xofigo®): increased risk of death and fractures in a randomised clinical trial with Xofigo® used in combination with abiraterone acetate and prednisolone/prednisone PDF, 36KB, File is accessible Date: 12. December 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: radium 223 dichloride

The company Bayer is circulating information on an increased incidence of deaths and fractures in a randomised clinical trial (15396/ERA-223 study) in patients with chemotherapy-naϊve castration-resistant prostate cancer (CRPC) receiving …

Dear Doctor Letter (Rote-Hand-Brief) on cladribine (Litak®, Leustatin®): changes in the product informations due to the risk of progressive multifocal leukoencephalopathy (PML) PDF, 101KB, File is accessible Date: 04. December 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: cladribine

The companies Lipomed GmbH and Janssen-Cilag GmbH are circulating information on the risk of progressive multifocal leukoencephalopathy (PML) associated with cladribine therapy which can occur up to several years after treatment with cladribine.

Dear Doctor Letter (Rote-Hand-Brief) on misoprostol (Misodel®): reports on excessive uterine tachysystole PDF, 409KB, File is accessible Date: 27. November 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: misoprostol

The company Ferring Arzneimittel GMBH is circulating information on reports of excessive uterine tachysystole that will possibly not subside with the use of tocolysis.

Dear Doctor Letter (Rote-Hand-Brief) on Gilenya®: new contraindications in patients with cardiac disorders PDF, 426KB, File is accessible Date: 07. November 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fingolimod

The company Novartis is circulating information on new contraindications in patients with cardiac disorders.