BfArM - Federal Institute for Drugs and Medical Devices

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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.

Viread: Possibility of counterfeits of the medicinal product in the legal supply chain in Germany Date: 10. April 2015 Topics: Pharmakovigilanz Type: Risk information

Active substance: tenofovir

The BfArM has received information that counterfeits of the centrally licensed medicinal product Viread 245 mg film-coated tablets are possibly on the market in Germany.

Medicinal products containing dimethyl fumarate (Tecfidera®, Fumaderm®): Progressive multifocal leukoencephalopathy (PML) in connection with the administration of medicinal products containing dimethyl fumarate Date: 07. April 2015 Topics: Pharmakovigilanz Type: Risk information

Active substance: dimethyl fumarate

The BfArM issues information that in Germany up to now overall 9 cases of PML (progressive multifocal leukoencephalopathy) have been reported in connection with the administration of Fumaderm® and 2 cases in connection with the administration …

Quinine for nocturnal leg cramps (Limptar® N): BfArM's notice regarding changes of the product informations within a national graduated plan procedure ("Stufenplanverfahren"), including a restriction of the indication, amongst others due to the risk of severe blood count changes (thrombocytopenias) Date: 02. April 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: quinine

The BfArM issues information on a national graduated plan procedure ("Stufenplanverfahren") regarding the active substance quinine for the indication nocturnal leg cramps.

Sofosbuvir: Arrhythmias as a possible interaction with other direct-acting antiviral agents (DAA) for the treatment of hepatitis C in combination with agents that could cause bradycardia (e.g. amiodarone) Date: 27. March 2015 Topics: Pharmakovigilanz Type: Risk information

Active substance: sofosbuvir

Signs of potential arrhythmias, especially the possibly life-threatening slowing of the heart rate (bradycardia), have become known especially due to case reports from France.

Metformin: Update of Summaries of Product Characteristics/Package Leaflets regarding contraindication for patients with impaired renal function Date: 27. March 2015 Topics: Pharmakovigilanz Type: Risk information

Active substance: metformin

The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) issues information that the Summaries of Product Characteristics/Package Leaflets of medicinal products containing metformin have …

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.

Medicinal products containing ambroxol and bromhexine: recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) and the Co-ordination group (CMDh) within a European safety review concerning the risk of hypersensitivity reactions Date: 10. March 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: ambroxol | bromhexine

The BfArM issues information on a recommendation by the PRAC and the resulting majority decision by the Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) within a European safety review in accordance with …

Neulasta®: Possibility of counterfeits being on the market Date: 06. March 2015 Topics: Pharmakovigilanz Type: Risk information

Active substance: pegfilgrastim

The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) has received information via the "Land" authority ("Landesbehörde") of Bavaria and via the EU's Rapid Alert System (RAS) that …

Cialis®: Counterfeit medicinal products from Italy - Update Date: 24. February 2015 Topics: Pharmakovigilanz Type: Risk information

Active substance: tadalafil

The BfArM is reporting further information from the company Lilly as the marketing authorisation holder of the originator product.

Information on theft of the medicinal product Sildaristo® produced by Aristo Pharma GmbH in Berlin Date: 12. February 2015 Topics: Pharmakovigilanz Type: Risk information

Active substance: sildenafil

The State Office of Health and Social Affairs in Berlin ("Landesamt für Gesundheit und Soziales", LaGeSo) has informed the BfArM of the theft of the medicinal product Sildaristo®.

Polymyxin-based products (colistin, colistimethate sodium): realisation of the EU Commission's implementing decision Date: 30. January 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: colistin | colistimethate sodium

Based on the review of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), the European Commission decided on 16 December 2014 to update the product informations of medicinal products containing …

Medicinal products containing testosterone: review of possible cardiac risks Date: 22. January 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: testosterone

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has reviewed the risk of cardiovascular diseases, particularly heart attacks, under treatment with testosterone.

Medicinal products containing ponatinib (Iclusig®): risk of blood vessel blockage Date: 15. January 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: Ponatinib

With the publication of the decision of the European Commission on 15 January 2015, the risk assessment procedure for Iclusig® was completed.

Medicinal products containing valproate and related substances: risk of anomalies in neonates Date: 13. January 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: valproate

On 19 November 2014, the Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) decided unanimously based on the recommendations of the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment …

Medicinal products containing Estradiol for topical administration: realisation of the EU Commission's implementing decision Date: 09. January 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: estradiol

In its notice of 9 January 2015, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the realisation of the corresponding implementing decision of the EU Commission C(2014)6030 of 19 August 2014

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).

Dear Doctor Letter (Rote-Hand-Brief) on Procoralan® (ivabradine): New contraindication and recommendations for minimisation of risks of cardiovascular events and severe bradycardias PDF, 1MB, File is accessible Date: 11. December 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ivabradine

The company Servier Deutschland GmbH is circulating information that concomitant use of ivabradine with verapamil or diltiazem is now contraindicated.

Marketing authorisations based on studies conducted by GVK Biosciences in India: suspension of marketing authorisation Date: 09. December 2014 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: various

In a notice dated 8 December 2014, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the suspension of several marketing authorisations that were based on a clinical trial conducted by GVK Biosciences in India.

Dear Doctor Letter (Rote-Hand-Brief) on Tecfidera® (dimethyl fumarate): Suspected case of progressive multifocal leukoencephalopathy (PML) PDF, 195KB, File is accessible Date: 04. December 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dimethyl fumarate

The company Biogen Idec GmbH is circulating information on a fatal case of progressive multifocal leukoencephalopathy (PML) in a patient with a severe and long-term lymphopenia treated with Tecfidera®.

Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing bromocriptine: Restrictions of indication regarding inhibition of lactation PDF, 1MB, File is accessible Date: 04. December 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: bromocriptine

The marketing authorisation holders of medicinal products containing bromocriptine are circulating information that bromocriptine should only be taken in strengths up to 2.5 mg per individual dose for prevention or inhibition of lactation …

Information on medicinal products affecting the renin-angiotensin system: Key elements for communication PDF, 42KB, File is accessible Date: 01. December 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ACE-Hemmer, Angiotensin-II-Rezeptor-Antagonisten, Aliskiren

The Pharmacovigilance Risk Assessment Committee (PRAC) has adopted key elements regarding communication of the outcome of the safety review regarding medicinal products that affect the renin-angiotensin system.

Oral bromocriptine-containing medicines: indicated in the prevention or suppression of physiological lactation post-partum Date: 28. November 2014 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: bromocriptine

In its notice of 27 November 2014, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the realisation of the corresponding implementing decision of the EU Commission of 30 October 2014 regarding medicinal products containing …

Information Letter on Eligard® (leuprorelin acetate depot injection): Risk of lack of efficacy due to incorrect reconstitution and administration PDF, 521KB, File is accessible Date: 28. November 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: leuprorelin acetate

The company Astellas Pharma GmbH is circulating information on a possible lack of clinical efficacy that may occur if the product is reconstituted incorrectly.

Counterfeit medicinal products in Spain Date: 26. November 2014 Topics: Pharmakovigilanz Type: Risk information

Active substance:

On 18 November 2014, the Spanish licensing authority Agencia Española de Medicamentos y Productos Sanitarios (AEMPS--Agencia Española de Medicamentos y Productos Sanitarios) issued information on initial findings on illegally traded medicinal …

Dear Doctor Letter (Rote-Hand-Brief) on Fenistil® 1 mg/ml solution for injection (dimethindene maleate): Quality defects; recall of two batches PDF, 483KB, File is accessible Date: 25. November 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dimethindene maleate

The company Novartis Consumer Health GmbH is sending out information on the recall of batches 11027154 and 11045012 of the medicinal product Fenistil® 1 mg/ml solution for injection as the vials of both batches partially exhibit leakage at the …

Medicinal products that affect the renin-angiotensin(-aldosterone) system (RAS/RAAS): realisation of the EU Commission's implementing decision Date: 13. November 2014 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: ACE-Hemmer | Angiotensin-II-Rezeptor-Antagonisten | Aliskiren

In its notice of 31 October 2014, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the realisation of the corresponding implementing decision (2014) 6371 of the EU Commission.