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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 …