BfArM - Federal Institute for Drugs and Medical Devices

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Dear Doctor Letter (Rote-Hand-Brief) on Noxafil® (posaconazole): Tablets and oral suspension are not interchangeable PDF, 784KB, File is accessible Date: 18. July 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: posaconazole

The company MSD is circulating information on the broad-spectrum antimycotic Noxafil® with regard to the use of different pharmaceutical forms.

Zydelig® for treatment of chronic lymphocytic leukaemia and follicular lymphoma: PRAC recommendation Date: 15. July 2016 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: idelalisib

The BfArM issues information on the recommendations of the Pharmacovigilance Risk Assessment Committee (PRAC) for physicians and patients in order to make use of the medicinal product Zydelig® as safe as possible.

Acitretin and teratogenicity: Extension of the period of pregnancy prevention to 3 years after end of treatment Date: 14. July 2016 Topics: Pharmakovigilanz Type: Risk information

Active substance: Acitretin

The BfArM issues information on the result of the European PSUR worksharing procedure for the active substance acitretin. It was determined that the current 2-year period of pregnancy prevention after end of treatment is not sufficient and …

Information letter on Etopophos® 100-/1000 mg (etoposide): Shortage and procedure for ordering PDF, 146KB, File is accessible Date: 14. July 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: etoposide

The company Bristol-Myers Squibb GmbH & Co. KGaA is circulating information regarding the shortage of Etopophos® 100-/1000 mg.

Dear Doctor Letter (Rote-Hand-Brief) on Adempas® (riociguat): New contraindication for patients with pulmonary hypertension in connection with idiopathic interstitial pneumonia (PH-IIP) PDF, 900KB, File is accessible Date: 05. July 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: riociguat

In coordination with the European Medicines Agency the companies Bayer and MSD are circulating a Dear Doctor Letter on Adempas® with information regarding preliminary results of the RISE-IIP study.

Implanon NXT®: Possible risks and complications associated with insertion, localisation, removal and migration PDF, 1MB, File does not meet accessibility standards Date: 27. June 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: etonogestrel

The company MSD Sharp & Dohme GmbH recommends that only those physicians should insert and remove Implanon NXT® who have completed training for the use of the NXT® applicator and techniques for insertion and removal of the Implanon NXT® …

Dear Doctor Letter (Rote-Hand-Brief) on Thalidomide Celgene®: New important information on virus reactivation and pulmonary hypertension PDF, 504KB, File is accessible Date: 21. June 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: thalidomide

The company Celgene GmbH is circulating information on cases of virus reactivation and pulmonary hypertension under treatment with thalidomide.

Cialis®: Counterfeit medicinal products discovered in Greece Date: 10. June 2016 Topics: Pharmakovigilanz Type: Risk information

Active substance: tadalafil

The Federal Institute for Drugs and Medical Devices (BfArM) calls attention to cases of counterfeits from Greece of Cialis 20 mg film-coated tablets for treatment of erectile dysfunction. This concerns packages with the lot numbers C334146 and …

Renewed Information Letter on Erwinase® 10,000 IU/vial (crisantaspase): Shortage and instructions for use for the additional batch 177G* PDF, 400KB, File does not meet accessibility standards Date: 02. June 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: crisantaspase

The company Jazz Pharmaceuticals Germany GmbH is circulating information on use and handling instructions (visual inspection and filtering) of the Erwinase batch 177G* imported from the United Kingdom.

Information Letter on Erwinase® 10,000 IU/vial (crisantaspase): Instructions for use and shortage PDF, 139KB, File does not meet accessibility standards Date: 02. June 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: crisantaspase

The company Jazz Pharmaceuticals Germany GmbH is circulating information on use and handling instructions (visual inspection and filtering) of the Erwinase batch 174G imported from the United Kingdom.

Carbomedac®: BfArM's recommendation to filter the medicinal product is cancelled Date: 19. May 2016 Topics: Pharmakovigilanz Type: Risk information

Active substance: Carboplatin

The company Medac Gesellschaft für klinische Spezialpräparate mbH has submitted documents to the BfArM proving that filtering the medicinal product Carbomedac® prior to use as recommended until now by the BfArM is no longer necessary.

Fusafungin (Locabiosol®): increasing number of severe hypersensitivity reactions. Date: 09. May 2016 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: Fusafungin

In its notice within the graduated plan procedure the BfArM revoked all marketing authorizations for fusafungin-containing medicinal products in Germany.

Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing fusafungine (Locabiosol®): revocation of marketing authorisation PDF, 262KB, File is accessible Date: 22. April 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fusafungine

By way of a Dear Doctor Letter, the company concerned is informing healthcare professionals of the revocation of the marketing authorisations of medicinal products containing fusafungine (Locabiosol® as mouth and nose spray) within the EU.

Dear Doctor Letter (Rote-Hand-Brief) on BCR-ABL tyrosine kinase inhibitors: Risk of reactivation of hepatitis B PDF, 339KB, File is accessible Date: 08. April 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: imatinib, dasatinib, nilotinib, bosutinib, ponatinib

The pharmaceutical companies concerned are circulating information on the risk of reactivation of hepatitis B after treatment with BCR-ABL tyrosine kinase inhibitors and the necessity of examining patients with regard to hepatitis B viral load …

Dear Doctor Letter (Rote-Hand-Brief) on Zydelig® (idelalisib): Restrictions of use PDF, 319KB, File is accessible Date: 24. March 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: idelalisib

The company Gilead Sciences GmbH is circulating information on interim recommendations on restrictions of use of Zydelig.

EMA recommends new safety measures for Zydelig®: close monitoring and use of antibiotics to prevent pneumonia Date: 21. March 2016 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: Idelalisib

EMA recommends new safety measures for Zydelig®: close monitoring and use of antibiotics to prevent pneumonia.

Inhalative corticosteroids (ICS) and pneumonia: recommendation by the PRAC Date: 21. March 2016 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: corticosteroids | inhalative

The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) has now completed its review of this known risk and has confirmed the increased risk of pneumonia.

Dear Doctor Letter (Rote-Hand-Brief) on Zaltrap® (aflibercept): Risk of osteonecrosis of the jaw PDF, 1MB, File does not meet accessibility standards Date: 17. March 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: aflibercept

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Zydelig® for treatment of chronic lymphocytic leukaemia and follicular lymphoma: initiation of a European safety review Date: 15. March 2016 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: idelalisib

The BfArM issues information on the initiation of a European safety review regarding Zydelig® due to serious adverse events. Zydelig® is authorised in the EU for treatment of two types of rare blood cancers.

Information letter on Xofigo® (Radium-223 dichloride): Change in NIST standard reference material PDF, 167KB, File does not meet accessibility standards Date: 15. March 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: radium-223 dichloride

The company Bayer Vital GmbH is circulating information that the National Institute of Standards and Technology (NIST) has recently revised the primary standardisation for Radium-223.