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Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing carbimazole or thiamazole: risk of acute pancreatitis and strengthened advice on contraception PDF, 2MB, File does not meet accessibility standards Date: 06. February 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: carbimazole, thiamazole

Marketing authorisation holders provide information on the need for effective contraception in women of childbearing age and on the risk of acute pancreatitis.

Dear Doctor Letter (Rote-Hand-Brief) on hormonal contraceptives: new warning regarding suicidal tendencies possibly linked to depression associated with use of hormonal contraception PDF, 2MB, File is accessible Date: 21. January 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Hormonelle Kontrazeptiva

The marketing authorisation holders of hormonal contraceptives are issuing information on the inclusion of a new warning on suicidal tendencies possibly linked to depression.

Dear Doctor Letter (Rote-Hand-Brief) on Sodium-Glucose-Co-Transporter 2 inhibitors (SGLT2i): risk of Fournier´s gangrene (necrotising fasciitis of the perineum) PDF, 965KB, File is accessible Date: 21. January 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: SGLT2 inhibitors

The Marketing Authorisation Holders (MAH) inform about the risk of Fournier´s gangrene (necrotising fasciitis of the perineum) associated with the use of SGLT2 inhibitors.

Dear Doctor Letter (Rote-Hand-Brief) for contraceptives containing dienogest and ethinylestradiol: risk of venous thromboembolism PDF, 239KB, File is accessible Date: 11. December 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dienogest, ethinylestradiol

The company Jenapharm GmbH & Co. KG provides information on the risk of venous thromboembolism (VTE) in women using contraceptives containing dienogest and ethinylestradiol compared to women using levonorgestrel and ethinylestradiol …

Information Letter on Palexia® 20 mg/ml oral solution (tapentadol): administration to children and adolescents in hospitals PDF, 1MB, File does not meet accessibility standards Date: 06. December 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: tapentadol

The company Grünenthal is circulating information on a new dosing pipette for weight-based dosing in children with a body weight of more than 16 kg.

Risk information for Colchicum-Dispert® and Colchysat®Bürger by the company Bürger Date: 20. November 2018 Topics: Pharmakovigilanz Type: Risk information

Active substance: Colchicin

Based on reports of overdosage leading to death, the dosing recommendations and warnings have been updated.

Suicidal tendencies possibly linked to depression associated with use of hormonal contraception Date: 15. November 2018 Topics: Pharmakovigilanz Type: Risk information

Active substance: hormonal contraceptives

As a result of a signal procedure on the risk of suicidal tendencies in connection with the use of hormonal contraceptives, a new warning is to be included in the Summary of Product Characteristics and Patient Information Leaflet.

Dear Doctor Letter (Rote-Hand-Brief) on Valproat: new restrictions on use; pregnancy prevention program to be put in place PDF, 173KB, File is accessible Date: 09. November 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: valproate

Marketing authorization holders of valproate-containing drugs inform about important new contraindications, strengthened warnings and measures to prevent valproate exposure during pregnancy.

Dear Doctor Letter (Rote-Hand-Brief) on systemic and inhaled fluoroquinolones: risk of aortic aneurysm and dissection PDF, 2MB, File is accessible Date: 26. October 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fluoroquinolones

The marketing authorisation holders of fluoroquinolone-containing medicinal products would like to inform about a new warning regarding the risk of aortic aneurysm and dissection associated with the use of systemic or inhaled fluoroquinolones.

Dear Doctor Letter (Rote-Hand-Brief) on hydrochlorothiazide: risk of non-melanoma skin cancer (basal cell carcinoma, squamous cell carcinoma) PDF, 3MB, File is accessible Date: 17. October 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: hydrochlorothiazide

Marketing authorisation holders of the products containing hydrochlorothiazide would like to inform about pharmacoepidemiological studies which have shown a risk of non-melanoma skin cancer with exposure to increasing cumulative doses of …