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Direct Healthcare Professional Communication (DHPC) on Nulojix® (belatacept): Risk of medication errors due to change in maintenance dose from 5 mg/kg to 6 mg/kg PDF, 217KB, File does not meet accessibility standards Date: 04. October 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Belatacept

Bristol Myers Squibb in agreement with the European Medicines Agency and the Federal Institute for Drugs and Medical Devices (BfArM) would like to inform you that With the implementation of a new manufacturing process, the maintenance dose for …

Direct Healthcare Professional Communication (DHPC) on Rubraca®▼(rucaparib-camsylate): restriction of indication PDF, 270KB, File is accessible Date: 08. August 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: rucaparib-camsylate

The company Clovis Oncology Ireland Ltd--Limited informs about a limitation of the indication with regard to monotherapy in adult patients.

Direct Healthcare Professional Communication (DHPC) on Hydroxyethyl starch (HES) solutions for infusion: suspension of marketing authorisations due to continued use in contraindicated patient populations with increased risk of serious harm PDF, 269KB, File is accessible Date: 01. July 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Hydroxyethyl starch, HES

Based on the results of the latest application study, the provisional suspension of marketing authorizations for HES-containing infusion solutions in the EU has been ordered. Germany will implement the suspension order as of November 24, 2023.

Direct Healthcare Professional Communication (DHPC) on dexmedetomidine: risk of increased mortality in intensive care patients ≤ 65 years of age PDF, 262KB, File does not meet accessibility standards Date: 15. June 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dexmedetomidine

Marketing authorization holders of dexmedetomidine-containing drugs provide information on results from the SPICE III study, in which the use of dexmedetomidine was associated with a higher risk of mortality compared with other sedatives in the age …

Direct Healthcare Professional Communication (DHPC) on Defitelio® (defibrotide): Do not use for prophylaxis of veno-occlusive disease (VOD) after post-hematopoietic stem-cell transplantation (HSCT) PDF, 158KB, File is accessible Date: 13. June 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: defibrotide

Gentium S.r.l would like to inform you that the Study 15-007 was stopped due to futility. Defitelio® is not to be used as prophylaxis for veno-occlusive disease.

Direct Healthcare Professional Communication (DHPC) on Ocaliva®▼ (obeticholic acid): New contraindication for treatment of primary biliary cholangitis (PBC) in decompensated cirrhosis or history of hepatic decompensation. PDF, 249KB, File is accessible Date: 09. June 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: obeticholic acid

The company Intercept Pharma International Ltd. informs about a new contraindication for the treatment of primary biliary cholangitis (PBC).

Direct Healthcare Professional Communication (DHPC) on Fosfuro® 3000 mg granules for oral solution (fosfomycin trometamol): Deletion of the indication perioperative antibiotic prophylaxis for transrectal prostate biopsy in adult men PDF, 1MB, File is accessible Date: 20. May 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fosfomycin trometamol

Apogepha Arzneimittel GmbH as the marketing authorisation holder of Fosfuro® 3000 mg informs that Fosfuro® 3000 mg (fosfomycin trometamol) is not authorised in the indication perioperative antibiotic prophylaxis in transrectal prostate biopsy in …

Direct Healthcare Professional Communication (Rote-Hand-Brief) on Natpar 100 micrograms/dose powder and solvent for solution for injection of the company Takeda: Expected supply shortage from July 1st, 2022 PDF, 212KB, File is accessible Date: 09. May 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Parathyroid hormone

Takeda informs of an expected supply shortage for the medicinal product Natpar 100 micrograms/dose strength due to manufacturing challenges.

Direct Healthcare Professional Communication (DHPC) on Rubraca®▼(rucaparib-camsylate): interim data from Study CO-338-043 (ARIEL4) show a decrease in overall survival compared to standard of care PDF, 261KB, File is accessible Date: 06. May 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: rucaparib-camsylate

The interim data from Study CO-338-043 (ARIEL4) show a decrease in overall survival compared to standard of care.

Direct Healthcare Professional Communication (Rote-Hand-Brief) on Accupro of the company Pfizer: Recall due to nitrosamine contamination PDF, 70KB, File is accessible Date: 28. April 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Quinapril hydrochloride

Pfizer informs about a precautionary recall of all strengths and pack sizes of the medicinal product Accupro at pharmacy level, as investigations have identified nitrosamine contamination.