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819 results

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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.

Ambroxol and bromhexine: realisation of the EU Commission's implementing decision Date: 23. February 2016 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: ambroxol | bromhexine

On 14 January 2016, the European Commission decided to update the texts of the Summaries of Product Characteristics/Package Leaflets of medicinal products containing ambroxol and bromhexine.

SGLT2 inhibitors: PRAC recommendation to minimise the risk of diabetic ketoacidosis, especially in atypical cases Date: 15. February 2016 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: canagliflozin | dapagliflozin | empagliflozin

The Pharmacovigilance Risk Assessment Committee of the European Medicines Agency has completed the European safety review on SGLT2 inhibitors and has issued recommendations to minimise the risk of diabetic ketoacidosis.

Protopic® – Herpes-simplex eye infections Date: 28. January 2016 Topics: Pharmakovigilanz Type: Risk information

Active substance: Tacrolimus (topische Anwendung)

The BfArM points out that herpes simplex infections of the eye have been included as a new adverse reaction in the product information of Protopic®.

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.

Mycophenolate (e.g. CellCept®): Update on the use of medicinal products containing mycophenolate during pregnancy after paternal exposure Date: 14. January 2016 Topics: Pharmakovigilanz Type: Risk information

Active substance: Mycophenolat

The BfArM is issuing further information as a follow-up to the reinforced warning of 26 October 2015 regarding the use of mycophenolate (mycophenolate mofetil or mycophenolic acid) during pregnancy.

Educational Materials Date: 14. January 2016 Topics: Pharmakovigilanz Type: Article

Educational Materials

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.