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443 results

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Information letter on Kineret® (anakinra) 100 mg and 100 mg/0.67 ml solution for injection in a pre-filled syringe: Visible solid deposits on the surface of the needle PDF, 155KB, File is accessible Date: 16. June 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: anakinra

The Swedish company Orphan Biovitrum AB (Sobi) issues information on deposits of the active substance on the surface of the needle.

Dear Doctor Letter (Rote-Hand-Brief) on Gilenya® (fingolimod): First reported case of progressive multifocal leukoencephalopathy (PML) PDF, 344KB, File is accessible Date: 04. May 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fingolimod

The company Novartis Pharma GmbH is circulating information on the first case report of PML in a patient taking fingolimod for multiple sclerosis (MS) without previous treatment with natalizumab or other immunosuppressive medicines.

Information Letter on Sustiva® (efavirenz) 30 mg/ml oral solution: Discontinuation and recommendation for switching patients to Sustiva® capsules or tablets PDF, 624KB, File is accessible Date: 04. May 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: efavirenz

The company Bristol-Myers Squibb GmbH & Co. KGaA is circulating information on discontinuation of Sustiva® 30 mg/ml oral solution by the end of October 2015.

Dear Doctor Letter (Rote-Hand-Brief) on Imnovid® (pomalidomide): Risk of serious hepatotoxicity, interstitial lung disease and cardiac failure PDF, 519KB, File is accessible Date: 04. May 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pomalidomide

The company Celgene GmbH is circulating safety information regarding reduction of the risk of serious hepatotoxicity, interstitial lung disease and cardiac failure.

Dear Doctor Letter (Rote-Hand-Brief) on Hydroxyzine (Atarax® and AH3®N film-coated tablets): New restrictions due to the risk of QT-interval prolongation PDF, 367KB, File is accessible Date: 17. April 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: hydroxyzine

The company UCB Pharma GmbH is circulating information on new restrictions in order to further minimise the known risk of QT-interval prolongation attributed to medicinal products containing hydroxyzine.

Dear Doctor Letter (Rote-Hand-Brief) on Ketoconazole HRA®: Risk of hepatotoxicity PDF, 842KB, File is accessible Date: 11. March 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ketoconazole

The company HRA Pharma is circulating information on the hepatotoxicity risk of its ketokonazole-containing medicinal product for treatment of endogenous Cushing's syndrome as well as on the measures to be taken prior to and during treatment.

Dear Doctor Letter (Rote-Hand-Brief) on Rapiscan® (regadenoson): New information regarding the minimisation of the stroke risk and prolongation of Rapiscan-induced seizures after administration of aminophylline PDF, 194KB, File is accessible Date: 22. December 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: regadenoson

The company Rapidscan Pharma Solutions is circulating new safety information. Postponement of regadenoson administration should be considered in patients with uncontrolled hypertension.

Dear Doctor Letter (Rote-Hand-Brief) on SonoVue® (sulphur hexafluoride): Revised contraindications, warnings and precautions PDF, 589KB, File is accessible Date: 18. December 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: sulphur hexafluoride

The company Bracco Imaging Deutschland GmbH is circulating information on rare but severe arrhythmias, sometimes fatal, in patients with cardiovascular instability during stress echocardiography procedures with SonoVue® used in combination …

Dear Doctor Letter (Rote-Hand-Brief) on CellCept® (mycophenolate mofetil): New warnings with regard to the risk of hypogammaglobulinaemia and bronchiectasis PDF, 2MB, File is accessible Date: 17. December 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: mycophenolate mofetil

The company Roche Pharma AG is circulating new safety information regarding the risk of hypogammaglobulinaemia and bronchiectasis for all products that release mycophenolic acid as the active metabolite.

Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing valproate (and related substances): Risks for the unborn child in case of exposure during pregnancy Date: 12. December 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: valproat, related substances

Important new information and increased safety warnings with regard to medicinal products containing valproate and related substances (sodium valproate, valproic acid, valproate semisodium and valpromide).