BfArM - Federal Institute for Drugs and Medical Devices

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Direct Healthcare Professional Communication (DHPC) on Miltefosin (Impavido® 10 mg/50 mg Capsules): new warning about ocular changes, including keratitis PDF, 638KB, File is accessible Date: 05. February 2021 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: miltefosine

The company Paesel und Lorei GmbH & Co. KG informs in coordination with the Federal Institute for Drugs and Medical Devices (BfArM) that in a few case reports complications of the eye (including keratitis) occurred under treatment with …

Direct Healthcare Professional Communication (DHPC) on Alkindi® (hydrocortisone granules in capsules for opening): risk of acute adrenal insufficiency when switching from crushed or compounded oral hydrocortisone formulations PDF, 798KB, File is accessible Date: 04. February 2021 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: hydrocortisone

Diurnal Europe B.V. informs about the report of an adrenal crisis in an infant who was switched from soluble hydrocortisone tablets to Alkindi®.

Ulipristal acetate 5 mg: temporary suspension of marketing authorisation for medicinal products for the treatment of uterine fibroids Date: 02. February 2021 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: ulipristal acetate

The Federal Institute for Drugs and Medical Devices (BfArM) has revoked the provisional suspension of the marketing authorisations for medicinal products and ordered changes to the marketing authorisations.

Direct Healthcare Professional Communication (DHPC) on ulipristal acetate 5 mg: indications for uterine fibroids restricted due to concerns of severe liver injury PDF, 681KB, File is accessible Date: 01. February 2021 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ulipristal acetate

The marketing authorization holders, in coordination with the European Medicines Agency (EMA) and the German Federal Institute for Drugs and Medical Devices (BfArM), inform about new restrictions for the use of ulipristal acetate 5 mg.

Retinoids: updated measures for pregnancy prevention as well as warnings on neuropsychiatric disorders after oral use Date: 07. January 2021 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: acitretin | adapalene | alitretinoin | bexarotene | isotretinoin | tazarotene | tretinoin

The BfArM requires pharmaceutical companies to report annually all pregnancies reported in connection with the use of acitretin, alitretinoin and isotretinoin.

Direct Healthcare Professional Communication (DHPC) on metamizole: risk of drug-induced liver injury PDF, 212KB, File is accessible Date: 15. December 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: metamizole

The marketing authorisation holders of metamizole-containing medicinal products in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) would like to inform you that cases of …

Direct Healthcare Professional Communication (DHPC) Gliolan® (5-aminolevulinic acid, 5-ALA): what to do in case of delayed surgery and information on fluorescence in non high-grade glioma PDF, 470KB, File is accessible Date: 01. December 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: 5-Aminolävulinsäure, 5-ALA

medac GmbH, in coordination with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM), provides information on the procedure for delayed operations and on fluorescence in non-high-grade gliomas.

Hydroxychloroquine and Chloroquine: psychiatric disorders Date: 27. November 2020 Topics: Pharmakovigilanz Type: Risk information

Active substance: hydroxychloroquine, chloroquine

Current information about psychiatric disorders for Chloroquine and Hydroxychloroquine.

Direct Healthcare Professional Communication (DHPC) on Gilenya® (fingolimod): updated recommendations to minimise the risk of drug-induced liver injury (DILI) PDF, 165KB, File is accessible Date: 10. November 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fingolimod

Novartis would like to inform you in agreement with European Medicines Agency (EMA) and Federal Institute for Drugs and Medical Devices, of cases of acute liver failure requiring liver transplant and clinically significant liver injury have …

Direct Healthcare Professional Communication (DHPC) on Tecfidera® (dimethyl fumarate): updated recommendations in the light of cases of progressive multifocal leukoencephalopathy (PML) in the setting of mild lymphopenia PDF, 90KB, File is accessible Date: 09. November 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dimethyl fumarate

Biogen Netherlands B.V. informs that cases of progressive multifocal leukoencephalopathy (PML) have been reported in patients treated with Tecfidera with existing mild lymphopenia (lymphocyte value ≥ 0.8 x 109/l and below the lower standard …