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Dear Doctor Letter (Rote-Hand-Brief) on Pedea® (ibuprofen as solution for injection): Shortage PDF, 401KB, File is accessible Date: 22. July 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ibuprofen

A temporary shortage in the supply of the medicinal product Pedea® for treatment of a haemodynamically significant patent ductus arteriosus Botalli in preterm newborn infants less than 34 weeks of gestational age has arisen due to the …

PlasmaVolume Redibag® by the company Baxter: Voluntary recall of the medicinal product PDF, 116KB, File is accessible Date: 18. July 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: hydroxyethyl starch

The marketing authorisation holder Baxter is circulating information that its medicinal product PlasmaVolume Redibag® (active substance: hydroxyethyl starch (HES)) is being recalled voluntarily from the market and requests to stop using this …

Information Letter on Zofran® (ondansetron) and generic medicinal products: Risk of QTc prolongation PDF, 548KB, File is accessible Date: 18. July 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ondansetron

This communication contains updated information regarding intravenous use of ondansetron for prevention and treatment of chemotherapy-induced nausea, retching and vomiting (CINV), as well as new recommendations for repeated administration and …

Medicinal products containing diclofenac: Cardiovascular risks PDF, 249KB, File is accessible Date: 16. July 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: diclofenac

The marketing authorisation holders of systemically acting medicinal products containing diclofenac are sending out information that new contraindications and warnings for these medicinal products have been decided following the Europe-wide …

Fumaderm® initial/Fumaderm® (fumaric acid derivatives): Avoiding the risk of opportunistic infections by adhering to regular laboratory controls and observing further warnings PDF, 679KB, File is accessible Date: 26. June 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fumaric acid derivatives

The company Biogen Idec GmbH points out that it is absolutely necessary when using the medicinal products Fumaderm® initial/Fumaderm® to observe the warnings given in the Summary of Product Characteristics with regard to regular monitoring of …

Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing tetrazepam (e.g. Musaril®): Ruling of suspension due to rare, serious skin reactions PDF, 331KB, File is accessible Date: 25. June 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: tetrazepam

The company Sanofi-Aventis Deutschland GmbH is sending out information that the marketing authorisations for medicinal products containing tetrazepam (e.g. Musaril®) have been suspended in the EU.

Trobalt® (retigabine): Risk of pigmentary changes PDF, 343KB, File is accessible Date: 24. June 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: retigabine

The company GlaxoSmithKline is sending out information that treatment with the medicinal product Trobalt® can lead to pigmentary changes of eye tissues, including the retina, as well as of the skin, lips and/or nails.

Dear Doctor Letter (Rote-Hand-Brief) on Revlimid® (lenalidomide): Important aspects with regard to clinical use PDF, 260KB, File is accessible Date: 20. June 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: lenalidomide

Celgene Europe Ltd. is sending out information on important aspects regarding the clinical use of Revlimid® (lenalidomide) for which a further indication was recently licenced.

Dear Doctor Letter (Rote-Hand-Brief) on cyproterone acetate 2 mg/ethinylestradiol 35 µg PDF, 292KB, File is accessible Date: 12. June 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: cyproterone acetate

Strengthening of warnings, new contraindications and updated indication.

Information Letter on CILEST® and PRAMINO® tablets: Recall of the entire stock from the market PDF, 337KB, File is accessible Date: 04. June 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ethinyl estradiol, norgestimate

The pharmaceutical manufacturer is sending out information on the recall of the entire stock of CILEST® and PRAMINO® from the market as both products are no longer available.

Dear Doctor Letter (Rote-Hand-Brief) on Samsca® (tolvaptan): liver injury PDF, 188KB, File is accessible Date: 23. May 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: tolvaptan

Information for healthcare professionals regarding the potential risk of liver injury due to Samsca® (tolvaptan).

Information Letter on Nipruss® (sodium nitroprusside): recall all batches PDF, 944KB, File is accessible Date: 23. May 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: sodium nitroprusside

As a precautionary measure and in co-ordination with the competent supervising authority, the company UCB Pharma GmbH is recalling all batches of Nipruss® dry substance for infusion after reconstitution (PZN 04746699).

Dear Doctor Letter (Rote-Hand-Brief) on Protelos® (strontium ranelate): Restriction of indication PDF, 301KB, File is accessible Date: 13. May 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: strontium ranelate

Recent data showing an increased risk of myocardial infarction have resulted in restrictions regarding the use of Protelos® (restricted indication, new contraindications and warnings).

Dear Doctor Letter (Rote-Hand-Brief) on Pletal® (cilostazol): New safety information PDF, 3MB, File is accessible Date: 02. May 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: cilostazol

As the result of a review of the benefits and risks of cilostazol and in collaboration with the European Medicines Agency, the indications for medicinal products containing cilostazol have been restricted.

Dear Doctor Letter (Rote-Hand-Brief) on Tavor® pro injectione 2 mg solution for injection (lorazepam): Recall PDF, 119KB, File is accessible Date: 02. May 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: lorazepam

Recall of Tavor® pro injectione 2 mg solution for injection due to possible contamination with glass splinters.

Increlex® 10 mg/ml solution for injection (mecasermin, recombinant human IGF-1): Temporary market shortage PDF, 208KB, File is accessible Date: 30. April 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: mecasermin, recombinant human IGF-1

The company Ipsen Pharma GmbH is sending out information that the medicinal product Increlex® 10 mg/ml solution for injection will presumably be out of stock starting early August 2013. This shortage is due to manufacturing difficulties and …

Information Letter on CAELYX®: As of Monday 29 April 2013, supply with the medicinal product will return to normal PDF, 408KB, File is accessible Date: 23. April 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pegylated liposomal doxorubicin

Janssen-Cilag is sending out information that the supply with CAELYX® 2 mg/ml concentrate for solution for infusion is returning to regular availability and that the "CAELYX® Managed Access Programme" is being terminated.

Dear Doctor Letter (Rote-Hand-Brief) on Thalidomide Celgene™ (thalidomide): Risk of second primary haematological malignancies PDF, 288KB, File is accessible Date: 08. April 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: thalidomide

The pharmaceutical manufacturer is sending out information on the risk of second primary haematological malignancies in patients treated with thalidomide.

Dear Doctor Letter (Rote-Hand-Brief) on INCIVO® (telaprevir): Occurrence of serious skin reactions PDF, 351KB, File is accessible Date: 08. April 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: telaprevir

The pharmaceutical manufacturer is sending out information on the occurrence of serious skin reactions associated with treatment with INCIVO®.

Dear Doctor Letter (Rote-Hand-Brief) on Mimpara® (cinacalcet): Occurrence of severe hypocalcaemia resulting in death PDF, 338KB, File is accessible Date: 26. March 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: cinacalcet

Important safety-relevant information regarding a fatal case with severe hypocalcaemia in a clinical study in children and adolescents.

Information Letter on NULOJIX® (belatacept): Increased occurrence of acute graft rejection PDF, 113KB, File is accessible Date: 26. March 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: belatacept

The pharmaceutical manufacturer is sending out information on the increased occurrence of acute graft rejection under treatment with NULOJIX® (belatacept) associated with rapid corticosteroid taper in patients at high immunologic risk for …

Dear Doctor Letter (Rote-Hand-Brief) on Fentanyl®-Janssen and Durogesic® SMAT (12, 25, 50, 75, 100 µg/h), transdermal patch (active substance: fentanyl): New warning Date: 11. March 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fentanyl

New warning regarding medicinal products (and generics) containing fentanyl and the possible occurrence of serotonin syndrome if used concomitantly with serotonergic medicines.

Information Letter on NeuroBloc® (botulinum toxin type B): Risks related to "off-label“ use PDF, 848KB, File is accessible Date: 25. February 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: botulinum toxin type B

Serious adverse events were observed in connection with NeuroBloc® if used outside the licensed indication ("off-label“).

Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing tolperisone: Risk of hypersensitivity reactions PDF, 155KB, File is accessible Date: 21. February 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: tolperisone

The pharmaceutical manufacturers are sending out information on the restriction of the indication for medicinal products containing tolperisone and on the risk of hypersensitivity reactions.

Information letter on Optimark® products (gadolinium): New peel-off tracking label PDF, 73KB, File is accessible Date: 21. February 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: gadolinium

In order to enable a better understanding on the use of contrast agents containing gadolinium (Gd-based contrast agents) within the European Union, the European Commission has requested all manufacturers of contrast agents containing …

Dear Doctor Letter (Rote-Hand-Brief) on Xagrid® (active substance: anagrelide hydrochloride): Serious cardiovascular adverse events PDF, 466KB, File is accessible Date: 06. February 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: anagrelide hydrochloride

The pharmaceutical manufacturer is sending out information on a connection between Xagrid® and serious cardiovascular adverse events even in patients without known heart disease. This letter includes a reminder that Xagrid® is only indicated …

Dear Doctor Letter (Rote-Hand-Brief) on Tredaptive® (combination of niacin/laropiprant): Discontinuation of marketing PDF, 584KB, File is accessible Date: 22. January 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: niacin, laropiprant

The pharmaceutical manufacturer is sending out information that due to new data available from a clinical trial the marketing of the medicinal product Tredaptive® has been discontinued and that therefore treatment with this medicinal product …

Dear Doctor Letter (Rote-Hand-Brief) on Pradaxa® (dabigatran etexilate): New contraindication PDF, 337KB, File is accessible Date: 09. January 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dabigatran etexilate

The pharmaceutical manufacturer is sending out information that the medicinal product Pradaxa® is now contraindicated in patients with artificial heart valves who require anticoagulant treatment.

Dear Doctor Letter (Rote-Hand-Brief) on Gilenya® (fingolimod): Recommendations revised in analogy to the recommendations for first use regarding cardiovascular monitoring in case of renewed treatment PDF, 56KB, File is accessible Date: 08. January 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fingolimod

Revised recommendations on repeated cardiovascular monitoring in case of renewed treatment with Gilenya®. These recommendations apply for patients following interruption of treatment and for patients with bradyarrhythmia requiring therapy …

Dear Doctor Letter (Rote-Hand-Brief) on Angiox® (bivalirudin): Inappropriate "bolus-only" dosing for PCI PDF, 235KB, File is accessible Date: 08. January 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: bivalirudin

Communication for healthcare professionals based on reports of IV bolus injections of Angiox® (bivalirudin) alone without immediately following IV infusions. The resulting sub-therapeutic plasma concentrations bear the risk of ineffective …