BfArM - Federal Institute for Drugs and Medical Devices

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Dear Doctor Letter (Rote-Hand-Brief) on certain intravenous fluids containing electrolytes and/or carbohydrates: risk of severe hyponatraemia PDF, 452KB, File is accessible Date: 07. June 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: electrolytes, carbohydrates

In agreement with the BfArM, the pharmaceutical entrepreneurs are circulating information on the risk of irreversible brain injury.

Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing dolutegravir (Tivicay®, Triumeq®, Juluca®): neural tube defects in babies whose mothers became pregnant while taking dolutegravir PDF, 510KB, File is accessible Date: 04. June 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dolutegravir

There are reports from an observational study on neural tube defects in babies, whose mothers became pregnant while taking dolutegravir.

Information Letter on flupirtine: recall and revocation of marketing authorisation PDF, 36KB, File is accessible Date: 04. June 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: flupirtine

Following the European benefit-risk assessment, marketing authorisations of medicinal products containing the active substance flupirtine are revoked on an EU-wide level due to the risk of liver damage.

Dear Doctor Letter (Rote-Hand-Brief) on Lynparza® (olaparib): risk of medication errors due to new dosage forms PDF, 552KB, File is accessible Date: 29. May 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: olaparib

Lynparza® capsules and Lynparza® tablets must neither be substituted 1:1 nor on a milligramme-to-milligramme basis.

Dear Doctor Letter (Rote-Hand-Brief) on azithromycin: increased recurrence of haematological malignancies and mortality in patients following haematopoietic stem cell transplantation (HSCT) under azithromycin PDF, 948KB, File is accessible Date: 03. May 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: azithromycin

The clinical trial ALLOZITHRO on the prevention of bronchiolitis obliterans syndrome (BOS) in patients after allogeneic haematopoietic stem cell transplantation (HSCT) was discontinued prematurely.

Dear Doctor Letter (Rote-Hand-Brief) on Inhixa® (enoxaparin sodium): risk of self-activation of the safety device in unopened, unused pre-filled syringes PDF, 681KB, File is accessible Date: 18. April 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: enoxaparin sodium

The company Techdow Pharma Germany GmbH is circulating information on rare cases of premature self-activation of the safety device in unopened, unused pre-filled Inhixa syringes.

Dear Doctor Letter (Rote-Hand-Brief) on Xofigo® (radium 223 dichloride): contraindicated in combination with abiraterone acetate and prednisolone/prednisone PDF, 115KB, File is accessible Date: 20. March 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: radium 223 dichloride

The company Bayer AG issues information that an interim analysis of the randomised clinical trial in patients with castration-resistant metastatic prostate cancer has shown an increased risk of deaths and fractures in patients receiving radium …

Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing sonidegib (Odomzo® capsules): important information for minimising the teratogenic risk PDF, 133KB, File does not meet accessibility standards Date: 27. February 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: sonidegib

Medicinal products containing sonidegib are embryotoxic and/or teratogenic and can cause embryo-foetal death or severe birth defects when administered to pregnant women; therefore, Odomzo® must not be taken during pregnancy.
Active substance: …

Dear Doctor Letter (Rote-Hand-Brief) on Esmya® 5 mg tablets (ulipristal acetate): restrictions of use, warnings regarding serious liver injury as well as recommendations for monitoring liver function PDF, 161KB, File is accessible Date: 19. February 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Ulipristal acetate

After reports of serious liver damage, including acute liver failure, in patients treated with Esmya® temporary measures have been taken.

Dear Doctor Letter (Rote-Hand-Brief) on OCALIVA® (obeticholic acid): differential dosing recommendations in primary biliary cholangitis (PBC) patients with moderate and severe hepatic impairment PDF, 361KB, File is accessible Date: 09. February 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: obeticholic acid

Due to the risk of serious liver injury in patients with moderate and severe hepatic impairment, all patients are to be monitored by way of laboratory and clinical assessment for progression of the PBC disease during treatment with obeticholic …

Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing mycophenolate mofetil (MMF)/mycophenolic acid (MPA): updated recommendations for contraception PDF, 264KB, File is accessible Date: 07. February 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: mycophenolate

As mycophenolate mofetil (MMF) and mycophenolic acid (MPA) are known to be genotoxic, it is recommended that the male patient or his female partner use reliable contraception during treatment and for at least 90 days after the end of the …

Dear Doctor Letter (Rote-Hand-Brief) on new contraindications of Saccharomyces boulardii (Saccharomyces cerevisiae HANSEN CBS 5926) in seriously ill or immunocompromised patients Date: 22. January 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Saccharomyces boulardii

The marketing authorisation holders of the medicinal products concerned issue information on rare cases of fungemia that led to death in seriously ill patients.

Information Letter on noradrenaline PDF, 3MB, File is accessible Date: 17. January 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: noradrenaline

The company Aguettant issues information on the marketing of a solution for infusion containing noradrenaline in two new ready-for-use strengths.

Information Letter on Haldol® (tablets, oral drops, solution, solution for injection) and Haldol Decanoat Depot®: clarification regarding Janssen-Cilag GmbH's Dear Doctor Letter of 21 December 2017 PDF, 261KB, File is accessible Date: 15. January 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: haloperidol

Due to questions regarding the recently circulated Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing haloperidol, the company Janssen-Cilag GmbH (Haldol®-Janssen) would like to clarify the aspects raised most frequently.

Dear Doctor Letter (Rote-Hand-Brief) on contrast media containing gadolinium: updated recommendations for use PDF, 388KB, File is accessible Date: 10. January 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: gadolinium

The marketing authorisation holders concerned are circulating information on indications confirmed by the European Medicines Agency (EMA) regarding low levels of gadolinium deposition in the brain following administration of contrast media …

Dear Doctor Letter (Rote-Hand-Brief) on Haldol® and Haldol Decanoat Depot® (haloperidol): changes in the indications and posology PDF, 689KB, File is accessible Date: 22. December 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: haloperidol

The company Janssen-Cilag wishes to inform that the European Medicines Agency (EMA) has conducted a procedure to harmonise the SmPCs, labelling and package leaflets of preparations containing haloperidol.

Dear Doctor Letter (Rote-Hand-Brief) on Eligard® (leuprorelin acetate): medication errors due to overtightening of the safety needle PDF, 559KB, File is accessible Date: 14. December 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: leuprorelin acetate

The company Astellas is circulating information on medication errors reported in connection with leakage of the medicinal product from the syringe..

Dear Doctor Letter (Rote-Hand-Brief) on Radium 223 dichloride (Xofigo®): increased risk of death and fractures in a randomised clinical trial with Xofigo® used in combination with abiraterone acetate and prednisolone/prednisone PDF, 36KB, File is accessible Date: 12. December 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: radium 223 dichloride

The company Bayer is circulating information on an increased incidence of deaths and fractures in a randomised clinical trial (15396/ERA-223 study) in patients with chemotherapy-naϊve castration-resistant prostate cancer (CRPC) receiving …

Dear Doctor Letter (Rote-Hand-Brief) on cladribine (Litak®, Leustatin®): changes in the product informations due to the risk of progressive multifocal leukoencephalopathy (PML) PDF, 101KB, File is accessible Date: 04. December 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: cladribine

The companies Lipomed GmbH and Janssen-Cilag GmbH are circulating information on the risk of progressive multifocal leukoencephalopathy (PML) associated with cladribine therapy which can occur up to several years after treatment with cladribine.

Dear Doctor Letter (Rote-Hand-Brief) on misoprostol (Misodel®): reports on excessive uterine tachysystole PDF, 409KB, File is accessible Date: 27. November 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: misoprostol

The company Ferring Arzneimittel GMBH is circulating information on reports of excessive uterine tachysystole that will possibly not subside with the use of tocolysis.