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Dear Doctor Letter (Rote-Hand-Brief) on Viekirax® (ombitasvir, paritaprevir, ritonavir) with or without Exviera® (dasabuvir): Important new safety information regarding liver function PDF, 444KB, File is accessible Date: 04. January 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ombitasvir, paritaprevir, ritonavir, dasabuvir

The company AbbVie Deutschland GmbH is circulating information on measures to reduce the risk of liver damage.

Information letters on Insuman® Basal and Insuman® Comb 25 - suspension for injection in 3-ml cartridges and Solo-Star® in pre-filled pens: Shortage Date: 01. December 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: insulin human

The company Sanofi-Aventis Deutschland GmbH is sending out letters with the information that as of December 2015 the medicinal products Insuman® Basal and Insuman® Comb 25 will not be available at all or only limitedly due to capacity issues …

Dear Doctor Letter (Rote-Hand-Brief) on Tecfidera® (dimethyl fumarate): New measures to reduce the risk of progressive multifocal leukoencephalopathy PML - enhanced monitoring and stopping rules PDF, 715KB, File is accessible Date: 24. November 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dimethyl fumarate

The company Biogen Idec GmbH is circulating information on important new measures to minimise the risk of progressive multifocal leukoencephalopathy (PML) during treatment with Tecfidera®.

Dear Doctor Letter (Rote-Hand-Brief) on Fumaderm® initial / Fumaderm® (fumaric acid ester): Measures to reduce the risk of progressive multifocal leukoencephalopathy (PML)
PDF, 713KB, File is accessible
Date: 24. November 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fumaric acid ester

After a hearing under the graduated plan procedure ("Stufenplanverfahren"), stage II and conclusion of the variation worksharing procedure, the company Biogen Idec GmbH is circulating information on measures to reduce the risk of progressive …

Acitretin and teratogenicity: Compliance with safety measures in women of childbearing potential Date: 19. November 2015 Topics: Pharmakovigilanz Type: Risk information

Active substance: acitretin

On a European level it is currently being discussed that the 2-year period of pregnancy prevention in patients of childbearing potential is possibly not sufficient and must therefore be extended to 3 years after end of treatment.

Dear Doctor Letter (Rote-Hand-Brief) on Thalidomide Celgene® (Thalidomide): Reduction of starting dose when combined with melphalan in patients over 75 years of age PDF, 422KB, File is accessible Date: 10. November 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Thalidomid

The company Celgene GmbH is circulating information that the starting dose of Thalidomide Celgene should be reduced when combined with melphalan and prednisone (MPT) in patients over 75 years of age with untreated multiple myeloma.

Dear Doctor Letter (Rote-Hand-Brief) on CellCept®: Serious risk of teratogenicity – strengthened advice on pregnancy prevention for women and men Date: 10. November 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: mycophenolate mofetil

The company Roche Pharma is circulating information that the advice regarding pregnancy prevention when using CellCept® has been strengthened considerably.

Dear Doctor Letter (Rote-Hand-Brief) on InductOs 1.5 mg/ml powder, solvent and matrix for implantation matrix: Shortage PDF, 72KB, File is accessible Date: 05. November 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dibotermin alfa

The company Medtronic BioPharma B.V. is circulating information that the medicinal product InductOs can currently not be supplied.

Ondansetron: contraindications and interactions if used concomitantly with apomorphine Date: 30. October 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: ondansetron

BfArM issues a notice within the graduated plan procedure ("Stufenplanbescheid") concerning the implementation of information on contraindications and interactions if used concomitantly with apomorphine.

Mycophenolate (e.g. CellCept®): Strengthening of warnings in order to prevent use during pregnancy
Date: 26. October 2015 Topics: Pharmakovigilanz Type: Risk information

Active substance: mycophenolate

The European Medicines Agency (EMA) has issued a warning that the active substance mycophenolate used in transplantation medicine must not be administered during pregnancy if other treatment alternatives are available.