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Dear Doctor Letter (Rote-Hand-Brief) on Zydelig® (idelalisib): Restrictions of use PDF, 319KB, File is accessible Date: 24. March 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: idelalisib

The company Gilead Sciences GmbH is circulating information on interim recommendations on restrictions of use of Zydelig.

Dear Doctor Letter (Rote-Hand-Brief) on Zaltrap® (aflibercept): Risk of osteonecrosis of the jaw PDF, 1MB, File does not meet accessibility standards Date: 17. March 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: aflibercept

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Information letter on Xofigo® (Radium-223 dichloride): Change in NIST standard reference material PDF, 167KB, File does not meet accessibility standards Date: 15. March 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: radium-223 dichloride

The company Bayer Vital GmbH is circulating information that the National Institute of Standards and Technology (NIST) has recently revised the primary standardisation for Radium-223.

Information Letter on SGLT2 inhibitors: Updated information on the risk of diabetic ketoacidosis PDF, 192KB, File is accessible Date: 14. March 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: canagliflozin, dapagliflozin, empagliflozin

After completion of the European safety review by the CHMP, the pharmaceutical entrepreneurs concerned are circulating information on the recommendation to minimise the risk of diabetic ketoacidosis.

Dear Doctor Letter (Rote-Hand-Brief) on Myfortic® (mycophenolate): Serious risk of teratogenicity – reinforced advice on pregnancy prevention for women and men PDF, 180KB, File is accessible Date: 01. March 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: mycophenolate sodium

The company Novartis Pharma AG is circulating information in a Dear Doctor Letter that the advice regarding pregnancy prevention when using Myfortic® has been reinforced considerably.

Dear Doctor Letter (Rote-Hand-Brief) on Fingolimod (Gilenya®): Risks related to the effects on the immune system PDF, 1MB, File is accessible Date: 20. January 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fingolimod

The company Novartis Pharma GmbH is circulating information on recent product information changes in relation to immunosuppressive effects.

Dear Doctor Letter (Rote-Hand-Brief) on Tarceva® (erlotinib): Restriction of indication PDF, 85KB, File is accessible Date: 14. January 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: erlotinib

The company Roche Pharma AG is circulating a Dear Doctor Letter with information on restrictions regarding the indications of Tarceva®.

Dear Doctor Letter (Rote-Hand-Brief) on Ampicillin+Sulbactam-ratiopharm® 1000/500 mg p.i. vials and Ampicillin+Sulbactam-ratiopharm® 2000/1000 mg p.i. vials: New information for use PDF, 133KB, File is accessible Date: 08. January 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ampicillin, sulbactam

The company Ratiopharm GmbH is circulating information that as a precautionary measure it is currently absolutely necessary to use a particle filter when administering the product.

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 …

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.

Information letter on Zelboraf®: Potentiation of radiation damage PDF, 105KB, File is accessible Date: 20. October 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: vemurafenib

The company Roche Pharma AG is circulating information, that cases of severe radiation damage have been reported in patients treated with radiation prior to, during or subsequent to treatment with Zelboraf.

Dear Doctor Letter (Rote-Hand-Brief) on Xalkori® (crizotinib): New recommendations regarding the risk of cardiac insufficiency PDF, 224KB, File is accessible Date: 14. October 2015 Topics: Presse Type: Direct Healthcare Professional Communication

Active substance: crizotinib

The company Pfizer Pharma GmbH is circulating information that severe, sometimes lethal, cases of cardiac insufficiency have been reported in patients with ALK-positive NSCLC treated with crizotinib.

Information Letter on Reminyl®: Serious skin reactions; Stevens-Johnson Syndrome and acute generalised exanthematous pustulosis PDF, 377KB, File is accessible Date: 22. September 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Galantaminhydrobromid

The company Janssen-Cilag is circulating information on a new warning for Reminyl®.

Dear Doctor Letter (Rote-Hand-Brief) on Betmiga® (mirabegron): New recommendations concerning the risk of increased blood pressure PDF, 413KB, File is accessible Date: 07. September 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: mirabegron

The company Astellas Pharma GmbH is circulating information that serious cases of hypertension and increased blood pressure have been reported under treatment with mirabegron.

Dear Doctor Letter (Rote-Hand-Brief) on InductOs 1.5 mg/ml powder, solvent and matrix for implantation matrix: Possible temporary shortage of the medicinal product PDF, 77KB, File is accessible Date: 13. August 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dibotermin alfa

The company Medtronic BioPharma B.V. is circulating information that InductOs is expected to run out of stock as of the end of October 2015.