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819 results

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Lapatinib (Tyverb®): Re-analysis of data on use following treatment with trastuzumab Date: 30. April 2019 Topics: Pharmakovigilanz Type: Risk information

Active substance: lapatinib

The European Medicines Agency (EMA) is updating the prescribing information for Tyverb® (lapatinib) after irregularities had been observed in results of a study involving postmenopausal women.

Dear Doctor Letter (Rote-Hand-Brief) on domperidone: reminder regarding measures to minimise cardiac risks PDF, 1MB, File is accessible Date: 29. April 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: domperidone

In agreement with the Federal Institute for Drugs and Medical Devices (BfArM), the marketing authorisation holders of medicinal products containing domperidone would like to remind you of the safety measures from the year 2014.

Dear Doctor Letter (available in German only) PDF, 2MB, File is accessible Date: 10. April 2019 Topics: Pharmakovigilanz Type: Download

Dear Doctor Letter (available in German only)

Information for patients (available in German only) PDF, 2MB, File is accessible Date: 10. April 2019 Topics: Pharmakovigilanz Type: Download

Information for patients (available in German only)

Dear Doctor Letter (Rote-Hand-Brief) on Euthyrox® (levothyroxine) new formulation tablets: monitoring of patients switching between tablets Date: 10. April 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: levothyroxine

Merck Serono GmbH would like to inform you in agreement with the Federal Institute for Drugs and Medical Devices that a new formulation of Euthyrox® (levothyroxine) tablets will be available End of April/Beginning of May 2019.

Dear Doctor Letter (Rote-Hand-Brief) on fluoroquinolone antibiotics: serious and long-lasting, disabling and potentially permanent side effects PDF, 2MB, File is accessible Date: 08. April 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fluoroquinolones

The marketing authorisation holders of medicinal products containing fluoroquinolone are circulating information on the incidence of serious and potentially permanent side effects associated with fluoroquinolones administered systemically or …

Metamizole: inconsistent information regarding dosage and contraindications Date: 04. April 2019 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: Metamizol

The European Medicines Agency (EMA) has started a review of medicines containing metamizole.

Dear Doctor Letter (Rote-Hand-Brief) on Xeljanz® (tofacitinib): increased risk of pulmonary embolism and mortality in patients with rheumatoid arthritis PDF, 277KB, File is accessible Date: 29. March 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: tofacitinib

Pfizer Pharma would like to inform you that the recommended dose of Xeljanz® (active ingredient: tofacitinib) for the treatment of rheumatoid arthritis must not be exceeded.

Dear Doctor Letter (Rote-Hand-Brief) on Genvoya®, Stribild® und Tybost®: increased risk of treatment failure and increased risk of mother-to-child transmission of HIV infection PDF, 815KB, File is accessible Date: 26. March 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: elvitegravir | cobicistat

Gilead Sciences informs that treatment with elvitegravir- and cobicistat-containing drugs should not be started during pregnancy.

Xeljanz® (tofacitinib): Increased risk of blood clots in lungs and death with higher dose for rheumatoid arthritis Date: 20. March 2019 Topics: Pharmakovigilanz Type: Risk information

Active substance: tofacitinib

EMA is advising healthcare professionals and patients not to exceed the recommended dose of Xeljanz® (tofacitinib) when treating rheumatoid arthritis.

Information Letter on Dantrolene 20 mg powder for solution for injection (DANTRIUM IV): use filtration device provided with product to reduce risk of injection site reactions PDF, 373KB, File is accessible Date: 01. March 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Dantrolen

The company Norgine informs on a new filtration device (BBraun Mini-Spike) to reduce the risk of reactions at the injection site.

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.