BfArM - Federal Institute for Drugs and Medical Devices

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819 results

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Medicines containing nomegestrol or chlormadinone: risk of meningioma Date: 24. November 2022 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: nomegestrol- and chlormadinone-containing medicines

The Federal Institute for Drugs and Medical Devices (BfArM) implements the decision of the European Commission C(2022) 7954 (final) of 28.10.2022 with a notice in the national graduated plan procedure, dated 22 November 2022.

Direct Healthcare Professional Communication (DHPC) on Xalkori® (Crizotinib): Visual disturbances, including risk of vision loss, need for monitoring in pediatric patients PDF, 212KB, File does not meet accessibility standards Date: 11. November 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Crizotinib

Pfizer informs that pediatric patients should be screened for visual impairment.

Direct Healthcare Professional Communication (DHPC) on chlormadinone acetate and nomegestrol acetate: Measures to minimise the risk of meningioma PDF, 412KB, File is accessible Date: 09. November 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: chlormadinone, nomegestrol

The marketing authorisation holders of chlormadinone- and nomegestrol- containing medicines would like to inform you that medicinal products containing chlormadinone acetate or nomegestrol acetate are only indicated when other interventions are …

Direct Healthcare Professional Communication (DHPC) on Imbruvica® (ibrutinib): New risk minimisation measures, including dose modification recommendations, due to the increased risk for serious cardiac events PDF, 167KB, File does not meet accessibility standards Date: 03. November 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ibrutinib

Janssen-Cilag International NV in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) would like to inform you that Ibrutinib increases the risk of fatal and serious cardiac arrhythmias …

Direct Healthcare Professional Communication (DHPC) on Custodiol® cardioplegic solution/ organ preservation solution, 500 ml and 1000 ml bottles: risk of visible particles in the solution, use of a filter PDF, 307KB, File does not meet accessibility standards Date: 07. October 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance:

Direct Healthcare Professional Communication (DHPC) on Custodiol® cardioplegic solution/ organ preservation solution, 500 ml and 1000 ml bottles: risk of visible particles in the solution, use of a filter

Direct Healthcare Professional Communication (DHPC) on Natpar 100 microgram/dose powder and solvent for solution for injection of the company Takeda: Discontinuation of manufacturing at the end of 2024 and update on shortage of 100 microgram/dose PDF, 302KB, File is accessible Date: 07. October 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 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 …

Rubraca® (rucaparib camsylate): cancer drug review based on preliminary study results Date: 30. September 2022 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: rucaparib camsylate

With the publication of the European Commission Decision on 21 September 2022, the Risk Assessment Procedure under Article 20 of Regulation (EC) No 726/2004 concerning "Rubraca - Rucaparib" was finalised.

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.

Is there a "refresh button"? Date: 05. August 2022 Topics: Pharmakovigilanz Type: FAQ

No, there is no "refresh button". However, you can refresh the site through the browser.

Does a notification via this portal replace the information on the graduated plan officer ("Stufenplanbeauftragter") in the marketing authorisation documents or the notification of corresponding changes? Date: 05. August 2022 Topics: Pharmakovigilanz Type: FAQ

No, according to section 22 (2) No. 5 AMG, the applicant must already provide proof at the time of the marketing authorisation application that he has a qualified person according to § 63a AMG and the contact details of this person must be provided. …

What happens if a marketing authorisation holder does not appoint a graduated plan officer ("Stufenplanbeauftragter")? Date: 05. August 2022 Topics: Pharmakovigilanz Type: FAQ

According to section 63a (1) AMG, there is a legal obligation to appoint a graduated plan officer. According to section 63a (3) AMG this person must be notified to the competent local authority and the competent higher federal authority. If this …

Does a marketing authorisation holder, who only holds central marketing authorisations, need to designate and notify a national graduated plan officer ("Stufenplanbeauftragter") in addition to the EU-QPPV? Date: 05. August 2022 Topics: Pharmakovigilanz Type: FAQ

A pharmaceutical entrepreneur, who only holds central marketing authorisations, does not need a graduated plan officer. In this case, the EU-QPPV is sufficient, who assumes the tasks of the graduated plan officer to the extent of the obligations …

Is the notification of the graduated plan officer (“Stufenplanbeauftragter”) subject to a fee? Date: 05. August 2022 Topics: Pharmakovigilanz Type: FAQ

Yes, the notification is subject to a fee according to the “Besondere Gebührenverordnung BMG” (special fee ordinance; BMGBGebV) (see section 3, fee item 16). To avoid delays, the official billing e-mail address of the party liable to pay the fee must …

Does the notification always apply to all products of a pharmaceutical entrepreneur? Date: 05. August 2022 Topics: Pharmakovigilanz Type: FAQ

If nothing else is specified, the reported graduated plan officer (deputy) is responsible for all products of the pharmaceutical entrepreneur. If there are restrictions in the responsibility, this must be indicated in the comment field. It should be …

What is the meaning of "pharmaceutical" and "medical" in the context of responsibility for different graduated plan officers ("Stufenplanbeauftragter")? Date: 05. August 2022 Topics: Pharmakovigilanz Type: FAQ

The tasks of the "medical" graduated plan officer include the tasks specified for the EU-QPPV according to Art. 104 (3) of Directive 2001/83/EC and for the graduated plan officer in section 63a (1) AMG.
For the "pharmaceutical” graduated plan …

Graduated plan officer Date: 05. August 2022 Topics: Pharmakovigilanz Type: Article

The Federal Institute for Drugs and Medical Devices (BfArM) publishes guidance on the new procedure for notifying the graduated plan officer via the PharmNet.Bund portal.

Does the notification also have to be sent separately to the local competent authority (“Länderbehörde”)? Date: 04. August 2022 Topics: Pharmakovigilanz Type: FAQ

According to § 63a (3) AMG, notifications must always be sent to both the competent higher federal authority (BfArM and/or PEI) and the competent local authority. The notification to the local authority are currently not possible via the …

Why can't I change the contact details of the pharmaceutical entrepreneur myself? Date: 04. August 2022 Topics: Pharmakovigilanz Type: FAQ

These data can only be changed by the employees of the higher federal authorities, as they belong to the master data of the database "Partnerinformationen" (partner information). If you wish to make any changes, please contact:

What should be indicated in the comment field? Date: 04. August 2022 Topics: Pharmakovigilanz Type: FAQ

In the comment field, assignments for different graduated plan officers of a marketing authorisation holder can be explained (e.g. for different pharmacovigilance systems).

If several graduated plan officers are reported for a pharmaceutical …

Does the notification have to be made by the pharmaceutical entrepreneur or can this also be sent by a service provider appointed by him? Date: 04. August 2022 Topics: Pharmakovigilanz Type: FAQ

Registration or de-registration can only be performed by the pharmaceutical entrepreneur himself or by a person appointed by him. If a service provider is supposed to be responsible for the pharmacovigilance system of a pharmaceutical entrepreneur, …

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 …