BfArM - Federal Institute for Drugs and Medical Devices

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442 results

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Information Letter on Fiasp® (insulin aspart): new colour scheme for cartridges and pre-filled pens PDF, 291KB, File is accessible Date: 06. July 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: insulin aspart

The company Novo Nordisk Pharma GmbH is circulating information on the fact that a new colour scheme will be introduced for Fiasp® products as of July 2018 in order to improve their discernibility from Tresiba®.

Dear Doctor Letter (Rote-Hand-Brief) on finasteride: risk of sexual dysfunction and psychiatric symptoms PDF, 2MB, File is accessible Date: 05. July 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: finasterid

Marketing Authorization Holders are circulating information on the risk of developing sexual dysfunctions and psychiatric symptoms under treatment with finasteride.

Dear Doctor Letter (Rote-Hand-Brief) on darunavir/cobicistat: increased risk of therapeutic failure and mother-to-child transmission of HIV PDF, 588KB, File is accessible Date: 25. June 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: darunavir, cobicistat

The company Janssen-Cilag GmbH is circulating information on the fact that treatment with darunavir/cobicistat should not be initiated during pregnancy.

Dear Doctor Letter (Rote-Hand-Brief) on filgrastim, pegfilgrastim, lipegfilgrastim and lenograstim: new warnings regarding aortitis associated with the use of granulocyte colony-stimulating factors (G-CSF) PDF, 444KB, File is accessible Date: 25. June 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: filgrastim, pegfilgrastim, lipegfilgrastim, lenograstim

In agreement with the Federal Institute for Drugs and Medical Devices (BFARM), the marketing authorisation holders are circulating information on the risk of aortitis associated with the administration of granulocyte colony-stimulating factors …

Information Letter on Actilyse® powder and solvent for solution for injection and infusion (alteplase) for acute ischaemic stroke: important extension of indication to include adolescents under 16 years of age PDF, 330KB, File is accessible Date: 22. June 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: alteplase

Actilyse® has been licensed for treatment of acute ischaemic stroke in adolescent patients under 16 years of age.

Dear Doctor Letter (Rote-Hand-Brief) on Maxipime® (cefepime): risk of serious neurologic adverse events in patients with renal impairment PDF, 178KB, File is accessible Date: 18. June 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: cefepime

Information is circulated on the risk of serious adverse events, including encephalopathy, in patients with renal impairment who received doses that exceeded the recommendations.

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.