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Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing mycophenolate mofetil (MMF)/mycophenolic acid (MPA): updated recommendations for contraception PDF, 264KB, File is accessible Date: 07. February 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: mycophenolate

As mycophenolate mofetil (MMF) and mycophenolic acid (MPA) are known to be genotoxic, it is recommended that the male patient or his female partner use reliable contraception during treatment and for at least 90 days after the end of the …

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.

Oral and rectal dosage forms of antiemetic agents containing dimenhydrinate and diphenhydramine for children up to the age of 3 years Date: 22. December 2017 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: dimenhydrinate | diphenhydramine

The Federal Institute for Drugs and Medical Devices (BfArM) issues information on the conclusion of the graduated plan procedure ("Stufenplanverfahren") regarding the use of oral and rectal antiemetic agents containing …

Mycophenolate: Updated recommendations on contraceptive measures for women and men
Date: 21. December 2017 Topics: Pharmakovigilanz Type: Risk information

Active substance: mycophenolate

The European Medicines Agency (EMA) has updated its recommendations on contraceptive measures for women and men taking medicinal products that contain mycophenolate.

Medicinal products containing modified-release paracetamol: measures for risk minimisation and to reduce harm in case of overdose Date: 15. December 2017 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: paracetamol - modified release

The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) confirms the PRAC recommendation that the marketing authorisations of medicinal products containing modified or prolonged release paracetamol shall be …

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..