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.