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Within what period of time must a registration or de-registration take place? Date: 04. August 2022 Topics: Pharmakovigilanz Type: FAQ

According to legislation, a notification must be made to the competent authority prior to the appointment of the graduated plan officer. In the event of an unforeseen change of the graduated plan officer, the notification must be made without delay. …

Is it possible to make modifications on my notification? Date: 04. August 2022 Topics: Pharmakovigilanz Type: FAQ

The pharmaceutical entrepreneur or the appointed service provider can initially save the notification and then continue to edit it. If the notification has been sent and has the status "completed", changes can only be made via a change notification.

Will I be informed about the status of a notification? Do I receive an acknowledgement of receipt? Date: 04. August 2022 Topics: Pharmakovigilanz Type: FAQ

The system automatically sends confirmations of receipt and information on the status of a notification by e-mail. If a graduated plan officer has been de-registered and a new one has not yet been notified, the system sends reminder e-mails.

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

Active substance: losartan

Azido impurity in losartan

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.