BfArM - Federal Institute for Drugs and Medical Devices

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92 results

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Azido impurity in losartan Date: 12. July 2022 Topics: Pharmakovigilanz Type: Risk information

Active substance: losartan

Azido impurity in losartan

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.

EU regulators request nitrosamine testing of metformin medicines (CHMP meeting highlights 12-15 October 2020) Date: 16. October 2020 Topics: Pharmakovigilanz Type: Risk information

Active substance: metformin

EU regulators request nitrosamine testing of metformin medicines

Remdesivir (Veklury®): PRAC checks signal for kidney damage Date: 06. October 2020 Topics: Pharmakovigilanz Type: Risk information

Active substance: remdesivir

PRAC has begun reviewing a safety signal for acute renal damage in some COVID-19 patients treated with Veklury® (Remdesivir).

Hydroxychloroquine: Renewed warning of risks when used to treat COVID-19 Date: 02. June 2020 Topics: Pharmakovigilanz Type: Risk information

Active substance: hydroxychloroquine, chloroquine

The European Medicines Agency (EMA) again warns about the risks of using hydroxychloroquine (and chloroquine) to treat COVID-19.

Hormone replacement therapy: PRAC completes review of new information on known breast cancer risk Date: 15. May 2020 Topics: Pharmakovigilanz Type: Risk information

Active substance: substances for hormone replacement therapy

The Committee for Pharmacovigilance Risk Assessment (PRAC) of the EMA recommends updating the current safety information of medicinal products for HRT, in relation to the known increased risk of breast cancer.

Hydroxychloroquine: Risk of serious side effects when used to treat COVID-19 Date: 29. April 2020 Topics: Pharmakovigilanz Type: Risk information

Active substance: hydroxychloroquine, chloroquine

The BfArM informs about the risk of serious side effects when using hydroxychloroquine for the treatment of COVID-19.

Increased ring fractures with vaginal rings Date: 01. April 2020 Topics: Pharmakovigilanz Type: Risk information

Active substance: ethinylestradiol, etonogestrel

The BfArM has received a large number of reports of breaks in the vaginal rings GinoRing® (Exeltis Germany GmbH), Cyclelle® (Hexal AG), VeriAristo® (Aristo Pharma GmbH) and Setlona® (Mylan Germany GmbH), which are used for hormonal …

COVID-19: Beware of falsified medicines from unregistered websites Date: 26. March 2020 Topics: Licensing Type: Risk information

Active substance: diverse

The BfArM and the EMA advise the public not to purchase medicines from unauthorised websites or other vendors trying to take advantage of the fears and concerns of the public.

Ranitidine: Recall of ranitidine containing drugs Date: 17. September 2019 Topics: Pharmakovigilanz Type: Risk information

Active substance: ranitidine

The Federal Institute for Drugs and Medical Devices (BfArM) informs that in the European Union there is a recall of drugs containing the active substance ranitidine produced by the active substance manufacturer Saraca Laboratories Limited.