BfArM - Federal Institute for Drugs and Medical Devices

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818 results

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Update of Direct Healthcare Professional Communication (DHPC) on Oncofolic 50 mg/ml solution for infusion/injection, strength 100 mg, 400 mg, 500 mg and 900 mg: Possible risk of visible particles in the solution, use of a filter PDF, 296KB, File does not meet accessibility standards Date: 27. May 2024 Topics: Pharmakovigilanz Type: Risk information

Active substance: disodium folinate

The company medac GmbH informs that during the ongoing stability program visible particles have been found in the medicinal product Oncofolic 50 mg/ml solution for injection/infusion.

Direct Healthcare Professional Communication (DHPC) on Giapreza 2.5 mg/ml concentrate for preparation of infusion solution: potentially low fill vials and important information regarding instructions for use PDF, 157KB, File does not meet accessibility standards Date: 27. May 2024 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: angiotensin II

The company Paion Deutschland GmbH informs that in several hospitals in the USA vials of the medicinal product Giapreza have been detected that are not filled with the required volume.

Information letter on Carmubris powder and solvent for solution for infusion: incorrect labeling PDF, 443KB, File does not meet accessibility standards Date: 23. May 2024 Topics: Pharmakovigilanz Type: Risk information

Active substance: carmustine

The company TILLOMED PHARMA GmbH informs about an incorrect labeling of three batches of the medicinal product Carmubris powder and solvent for solution for infusion

Medicinal products containing hydroxyprogesterone: safety review Date: 22. May 2024 Topics: Pharmakovigilanz Type: Risk information

Active substance: hydroxyprogesterone

EMA’s safety committee, PRAC, has recommended the suspension of the marketing authorisations for medicines containing 17-hydroxyprogesterone caproate (17-OHPC) in the European Union (EU).

Direct Healthcare Professional Communication (DHPC) on Irenate (sodium perchlorate) drops from Austria: Risk of incorrect dosing due to a different dosage (number of drops per millilitre) PDF, 274KB, File does not meet accessibility standards Date: 08. May 2024 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: sodium perchlorate

Irenate (sodium perchlorate) drops from Austria: Risk of incorrect dosing due to a different dosage a different dosage (number of drops per millilitre).

Direct Healthcare Professional Communication (DHPC) on oral retinoids (acitretin, alitretinoin and lsotretinoin): Reminder of existing restrictions to prevent exposure during pregnancy PDF, 383KB, File is accessible Date: 02. May 2024 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: acitretin, alitretinoin, isotretinoin

The marketing authorisation holders of acitretin-, alitretinoin- and isotretinoin-containing medicinal products remind you of the pregnancy prevention program for oral retinoids.

Information Letter on Aptivus 250 mg soft capsules: Missing or barely readable capsule imprint PDF, 112KB, File does not meet accessibility standards Date: 19. April 2024 Topics: Pharmakovigilanz Type: Risk information

Active substance: tipranavir

The company Boehringer Ingelheim Pharma GmbH & Co. KG informs that batch 308715 of the medicinal product Aptivus 250 mg soft capsules (120 capsules per bottle) may contain capsules with only a faint imprint “TPV 250” or without this imprint at …

Pseudoephedrine: risks of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) Date: 04. April 2024 Topics: Pharmakovigilanz Type: Risk information

Active substance: pseudoephedrine

With the publication of the European Commission's decision, the risk assessment procedure according to Article 31 of Directive 2001/83/EC on medicinal products containing pseudoephedrine has been completed.

Start of a review concerning the conduct of studies at Synapse Labs Pvt. Ltd., India Date: 25. March 2024 Topics: Pharmakovigilanz Type: Risk information

Active substance: various

On 21 March 2024, EMA’s human medicines committee (CHMP) confirmed its recommendation to suspend or not grant the marketing authorisations of a number of generic medicines tested by Synapse Labs Pvt. Ltd., a contract research organisation (CRO) …

Direct Healthcare Professional Communication (DHPC) on Paxlovid (nirmatrelvir, ritonavir): drug interactions with certain immunosuppressants, including tacrolimus PDF, 371KB, File is accessible Date: 21. March 2024 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: nirmatrelvir, ritonavir

Pfizer reminds of already known drug interactions of paxlovid with certain immunosuppressants, including tacrolimus, with potentially life-threatening and fatal consequences.

Information Letter on Spiolto Respimat: Possibly defective dose indicator PDF, 105KB, File does not meet accessibility standards Date: 01. March 2024 Topics: Pharmakovigilanz Type: Risk information

Active substance: tiotropium bromide/olodaterol hydrochloride

The company Boehringer Ingelheim Pharma GmbH & Co. KG informs about possibly defective dose indicators in two batches of the medicinal product Spiolto Respimat 2.5 micrograms/2.5 micrograms.

Direct Healthcare Professional Communication (DHPC) on combined hormonal contraceptives with chlormadinone acetate/ethinyl estradiol: Slightly increased risk of venous thromboembolism PDF, 401KB, File is accessible Date: 23. February 2024 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: chlormadinone acetate, ethinyl estradiol

The marketing authorization holders of combined hormonal contraceptives containing chlormadinone acetate and ethinyl estradiol provide information about a slightly increased risk of venous thromboembolism.

Direct Healthcare Professional Communication (DHPC) on valproate-containing medicines: potential risk of neurodevelopmental disorders in children of fathers treated with valproate PDF, 955KB, File is accessible Date: 19. February 2024 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: valproate

The marketing authorisation holders of valproate-containing medicinal products would like to inform you about new measures regarding an increased risk of neurodevelopmental disorders in children born to men treated with valproate.

Contrast agents containing gadolinium: deposits in the brain and other tissues Date: 16. February 2024 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: gadolinium

For contrast agents containing gadolinium, the suspension of marketing authorisations has been extended until 28 February 2026.

Direct Healthcare Professional Communication (DHPC) on pseudoephedrine: risks of posterior reversible encephalopathy syndrome and reversible cerebral vasoconstriction syndrome Date: 15. February 2024 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pseudoephedrine

Few cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported with the use of pseudoephedrine-containing medicinal products.

Valproate: Potential risk of neurodevelopmental disorders in children born to men treated with valproate medicines Date: 26. January 2024 Topics: Pharmakovigilanz Type: Risk information

Active substance: valproate

The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) endorsed precautionary measures recommended by EMA’s safety committee (PRAC) for the treatment of male patients with valproate medicines.

Valproate: Potential risk of neurodevelopmental disorders in children born to men treated with valproate medicines Date: 12. January 2024 Topics: Pharmakovigilanz Type: Risk information

Active substance: valproate

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recommends precautionary measures for the treatment of male patients with valproate-containing medicinal products.

Valproate: risk of congenital malformations and developmental problems associated with use during pregnancy Date: 12. January 2024 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: valproate

Educational material on medicinal products containing valproate

Information Letter on Leqvio 284 mg solution for injection in a pre-filled syringe: Important information regarding instructions for use before injection PDF, 1MB, File is accessible Date: 21. December 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Inclisiran

The company Novartis informs about difficulties in moving the syringe plunger resulting in the inability to inject Leqvio.

Direct Healthcare Professional Communication (DHPC) on miltefosine (Impavido 10 mg/50 mg capsules): Updated warning on ocular changes, including keratitis PDF, 325KB, File is accessible Date: 14. December 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: miltefosine

The company Paesel und Lorei GmbH & Co. KG informs about an updated warning regarding ocular changes.

Direct Healthcare Professional Communication (DHPC) on etoposide (not etoposide phosphate): hypersensitivity reactions with the use of inline filters PDF, 237KB, File is accessible Date: 14. December 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: etoposide

The marketing authorization holders of medicinal products containing etoposide (not etoposide phosphate) inform that there is an increased risk of infusion-related hypersensitivity reactions when using inline filters.

Direct Healthcare Professional Communication (DHPC) on Furosemid-hameln 10 mg/ml (250 mg in 25 ml; 10 x 25 ml ampoules; PZN 16833989): visible particles PDF, 155KB, File is accessible Date: 12. December 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: furosemide

Furosemide-hameln ampoules may contain isolated visible particles. The batches mentioned should be checked visually before use.

Hydroxyethyl-starch containing Medicines: introduction of new measures to protect patients Date: 24. November 2023 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: hydroxyethyl starch | HES

The Federal Institute for Drugs and Medical Devices (BfArM) publishes updated information on marketability.

Direct Healthcare Professional Communication (DHPC) on hydroxyethyl starch (HES) solutions for infusion: measures to minimise risks associated with off-label use PDF, 187KB, File is accessible Date: 21. November 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: hydroxyethyl starch

The Federal Institute for Drugs and Medical Devices (BfArM) has decided that the conditions for lifting the suspension are meanwhile fulfilled. Infusion solutions containing HES may only be used in the approved indications.

DHPC (Rote-Hand-Brief) on Profact Depot 9.45 mg 3-month implant: Risk of premature implant dissolution/future adjustment of the storage temperature PDF, 142KB, File is accessible Date: 17. November 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Buserelin

The company Cheplapharm Arzneimittel GmbH informs about an insufficient release of the active substance in the last time fraction (day 78 - 91) of the in vitro dissolution test.

Direct Healthcare Professional Communication (DHPC) on omega-3 fatty acid-containing drugs: dose-dependent increased risk of atrial fibrillation in patients with established cardiovascular disease or cardiovascular risk factors PDF, 251KB, File is accessible Date: 16. November 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: omega-3 fatty acid

The marketing authorisation holders of medicines containing omega-3 fatty acids inform that systematic reviews and meta-analyses of randomised controlled trials show a dose-dependent increased risk of atrial fibrillation.

Azithromycin: re-evaluation of the benefits and risks Date: 10. November 2023 Topics: Pharmakovigilanz Type: Risk information

Active substance: azithromycin

EMA’s human medicines committee (CHMP) has started a review of systemic medicines.

Direct Healthcare Professional Communication (DHPC) on topiramate: New restrictions to prevent exposure during pregnancy PDF, 206KB, File is accessible Date: 02. November 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: topiramate

The marketing authorisation holders of medicinal products containing topiramate provide information on the implementation of a pregnancy prevention programme for topiramate.

Ocaliva: review started Date: 13. October 2023 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: obeticholic acid

EMA’s human medicines committee (CHMP) has started a review of the medicine Ocaliva (obeticholic acid), used to treat adults with primary biliary cholangitis (PBC).

Direct Healthcare Professional Communication (DHPC) on InfectoCillin powder for oral solution: Defective sealing insert in the cap PDF, 152KB, File does not meet accessibility standards Date: 28. September 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Phenoxymethylpenicillin potassium

The company InfectoPharm Arzneimittel und Consilium GmbH informs about a quality defect of the medicinal products InfectoCillin 400 powder for oral solution, 100 ml and InfectoCillin 500 powder for oral solution, 100 ml due to a defect of the cap.