BfArM - Federal Institute for Drugs and Medical Devices

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818 results

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Information letter on ERWINASE ® 10,000 IU/vial powder for solution for injection: precautionary measures when administering ERWINASE vials from batches 181a* and 182a* Date: 14. August 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: asparaginase

Due to shortage, ERWINASE® 10,000 IU/vial powder for solution for injection is currently only available under consideration of the provisions of Section 73 (3) AMG.

Counterfeits of the medicinal product VELCADE® 3.5 mg powder for solution for injection discovered in Germany Date: 14. August 2017 Topics: Pharmakovigilanz Type: Risk information

Active substance: bortezomib

The Federal Institute for Drugs and Medical Devices (BfArM) is issuing information on counterfeits of the medicinal product VELCADE 3.5 mg powder for solution for injection by Janssen-Cilag International NV, Belgium which were was found in …

Information letter on Trisenox® (arsenic trioxide): import from third country in order to avert shortages Date: 03. August 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: arsenix trioxide

The company Teva GmbH is circulating information on the fact that due to problems in the manufacture of Trisenox there will be a shortage on the European market during mid/late August 2017. However, these manufacturing issues do not affect the …

Counterfeits of the medicinal product Xeplion® 150 mg extended-release suspension for injection (batches GFB4D00_BG-RO and GEB3Z00_BG-RO) have reached the German market (including amendments of 2 August 2017, 28 July 2017 and 26 July 2017) Date: 02. August 2017 Topics: Pharmakovigilanz Type: Risk information

Active substance: paliperidon

The Federal Institute for Drugs and Medical Devices (BfArM) has received new information on a further batch concerned in the case of counterfeits of the medicinal product Xeplion 150 mg extended-release suspension for injection (active …

Omnitrope® 15 mg / 1.5 ml solution for injection (somatropin) Batch EL9738: Counterfeit being offered in German packaging Date: 18. July 2017 Topics: Pharmakovigilanz Type: Risk information

Active substance: somatropin

The Federal Institute for Drugs and Medical Devices (BfArM) refers to counterfeits of the medicinal product Omnitrope® 15 mg / 1.5 ml solution for injection by the company Sandoz reported in France, Denmark and Mexico. The medicinal product …

Arixtra® (fondaparinux sodium): shortage following interrupted production due to a minor defect affecting the needle guard PDF, 248KB, File is accessible Date: 18. July 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fondaparinux sodium

The company Aspen Pharma Trading Limited is circulating information on the fact that a minor defect affecting the needle guard of some Arixtra syringes has led to quarantine of several batches and interrupted production.

Dear Doctor Letter (Rote-Hand-Brief) on Imbruvica® (ibrutinib): risk of hepatitis B re-activation PDF, 490KB, File is accessible Date: 18. July 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ibrutinib

The company Janssen-Cilag GmbH is circulating information on the fact that cases of hepatitis B virus (HBV) re-activation have occurred during treatment with Imbruvica®. Therefore, patients should be examined with regard to HBV infection prior …

Marketing authorisations based on studies conducted by the company Micro Therapeutic Research Labs in India: suspension of marketing authorisations Date: 13. July 2017 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: various

In a notice dated 13 July 2017, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the provisional suspension of generic marketing authorisations based on clinical trials conducted by the company Micro Therapeutic Research …

Introduction of a patient alert card for medicinal products containing valproate and related substances Date: 13. July 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: valproate and related substances

In a notice dated 10 April 2017, the Federal Institute for Drugs and Medical Devices (BfArM) ruled the introduction of a patient alert card for medicinal products containing valproate as a supplementary risk minimisation measure. The companies …

Symbioflor 2: recommendations of the Committee for Medicinal Products for Human Use regarding further use and restrictions of use Date: 04. July 2017 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: escherichia coli

In its review of Symbioflor 2, the European Medicines Agency EMA has concluded that the medicinal product can continue to be used for treatment of irritable bowel syndrome in adults. However, it should no longer be taken to treat so-called …

Dear Doctor Letter (Rote-Hand-Brief) on Uptravi® (selexipag): contraindication for concomitant administration of strong CYP2C8 inhibitors PDF, 804KB, File is accessible Date: 14. June 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: selexipag

The company Actelion Pharmaceuticals Deutschland GMBH is circulating information that a contraindication for concomitant administration of Uptravi® (selexipag) and strong inhibitors of CYP2C8 (e.g. gemfibrozil) has been introduced.

Epclusa® 400 mg/100 mg film-coated tablets (batch 15SFPD119): Counterfeit in German packaging offered to wholesaler Date: 18. May 2017 Topics: Pharmakovigilanz Type: Risk information

Active substance: sofosbuvir, velpatasvir

The Federal Institute for Drugs and Medical Devices (BfArM) reports that a counterfeit of the company Gilead's medicinal product Epclusa® 400 mg/100 mg film-coated tablets was offered to a wholesaler in Germany.

Direct-acting antivirals used for treating Hepatitis C: possible hepatitis B re-activation Date: 05. May 2017 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: daclatasvir | dasabuvir | sofosbuvir/ledipasvir | simeprevir | sofosbuvir | ombitasvir/paritaprevir/ritonavir

The European Medicines Agency (EMA) confirms its recommendation for hepatitis B screening of all patients before starting treatment with direct-acting antiviral drugs for the treatment of hepatitis C

Dear Doctor Letter (Rote-Hand-Brief) on Cotellic® (cobimetinib): risk of haemorrhage and rhabdomyolysis PDF, 230KB, File is accessible Date: 24. April 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: cobimetinib

The company Roche Pharma AG is sending out information on the risk of haemorrhage and rhabdomyolysis as well as new recommendations on dose modifications when taking Cotellic® (cobimetinib). Prior to initiating treatment, serum CPK and …

Information Letter on Trobalt® (retigabine): worldwide withdrawal PDF, 103KB, File is accessible Date: 24. April 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: retigabin

The company GlaxoSmithKline GmbH & CO KG is sending out information that as of the end of June 2017, all strengths of the medicinal product Trobalt® (retigabine) will be discontinued on a worldwide level and will thus cease to be …

Dienogest 2 mg and ethinylestradiol 0.03 mg for treatment of acne: use for treatment of acne possible if other specific treatments are not effective Date: 18. April 2017 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: dienogest, ethinylestradiol

In its notice of 5 April 2017, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the realisation of the corresponding implementing decision of the EU Commission C(2017) 2057 final of 22 March 2017. The European safety …

Medicinal products containing valproate: risks of use during pregnancy Date: 18. April 2017 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: valproate

In view of renewed discussions and assessments on a European level as well as current findings and discussions with scientific societies, the BfArM also considers it necessary to introduce a patient alert card as a further measure in addition …

Information letter on Clexane® (enoxaparin sodium): update of the information on the strength of the medicinal product, as well as on dosage recommendations and recommendations for use PDF, 2MB, File is accessible Date: 13. April 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: enoxaparin sodium

The company Sanofi-Aventis Deutschland GmbH is sending out information that the information on the effective strength of the medicinal product, the dosage recommendation for the treatment of deep vein thrombosis (DVT) and pulmonary embolism …

Dear Doctor Letter (Rote-Hand-Brief) on Fastjekt®/Fastjekt® Junior: recall of individual batches due to possible defects PDF, 297KB, File is accessible Date: 13. April 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Epinephrin

In coordination with the competent supervisory authority, the regional council ("Regierungspräsidium") in Darmstadt, the company Meda Pharma GmbH & Co. KG has initiated a voluntary recall of the listed batches of the adrenaline …

Renewed information on Erwinase® 10,000 IU/vial (crisantaspase): shortage and instructions for use for further batches 179a* and 180a* PDF, 260KB, File is accessible Date: 12. April 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: crisantaspase

The company Jazz Pharmaceuticals Germany GmbH is circulating information on the fact that, due to a temporary shortage, Erwinase® 10.000 I.U./vial powder for solution for injection is currently only available under consideration of the …

Dantrolen i.v.: packages no longer contains water for injection PDF, 220KB, File is accessible Date: 22. March 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dantrolene

The company Norgine GmbH is circulating information that as of April 2017 (the 12 vial pack) or May 2017 (the 36 vial pack), packages of Dantrolen i.v. newly placed on the market no longer contain water for injection. Care must be taken that …

Medicinal products containing valproate: risks of use during pregnancy PDF, 103KB, File is accessible Date: 21. March 2017 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: Valproate

A notice of annulment was sent out for medicinal products for which the marketing authorisation holder had renounced the marketing authorisation.

Dear Doctor Letter (Rote-Hand-Brief) on Viread® 204 mg film-coated tablet: incorrect dosage information in previous Summaries of Product Characteristics PDF, 242KB, File is accessible Date: 15. March 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: tenofovir disoproxil

The company Gilead Sciences GmbH is circulating information on incorrect dosage information in the Summaries of Product Characteristics of Viread 204 mg film-coated tablets.

Medicinal products containing valproate: risks of use during pregnancy Date: 10. March 2017 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: valproate

Introduction of a patient alert card for medicinal products containing valproate

Dear Doctor Letter (Rote-Hand-Brief) on Viridal® 40 µg powder and solvent for injection: recall due to membrane defects PDF, 1MB, File is accessible Date: 06. March 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Alprostadil

The company UCB Pharma GmbH is circulating information on a voluntary recall of the medicinal product Viridal® due to defective membranes of the glass cartridges.

SGLT2 inhibitors (prviously canagliflozin): possibly increased risk of lower-extremity amputations Date: 10. February 2017 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: Canagliflozin | Dapagliflozin | Empagliflozin

The BfArM issues information on the extension of the European safety review regarding canagliflozin to include all SGLT2 inhibitors.

Medicinal products containing colchicine (Colchysat Bürger®) and reports of medication errors: restriction of pack size to 30 ml - hearing within a graduated plan procedure ("Stufenplanverfahren"), stage II Date: 09. February 2017 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: colchicine

The BfArM issues information on the initiation of a graduated plan procedure concerning the medicinal product Colchysat Bürger®.

Information Letter on Erwinase® 10.000 IU/vial, powder for solution for injection: information on temporary shortage PDF, 261KB, File is accessible Date: 31. January 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: crisantaspase

The company Jazz Pharmaceuticals Germany GmbH is circulating information on the fact that, due to a temporary shortage, Erwinase® 10.000 I.U./vial powder for solution for injection is currently only available under consideration of the …

Norditropin® SimpleXx® 15 mg/1,5 ml (Badge DC80754): Counterfeit in the illegal distribution chain Date: 28. December 2016 Topics: Pharmakovigilanz Type: Risk information

Active substance: somatropin

The Federal Institute for Drugs and Medical Devices (BfArM) reports that a counterfeit of the medicinal product Norditropin® SimpleXx® 15 mg/1,5 ml solution for injection by the company Novo Nordisk has been discovered in the illegal …

iCalcium folinate and 5-fluorouracil: incompatibilities between the injectable forms Date: 21. December 2016 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: calcium folinate | 5-fluorouracil

The BfArM has initiated a graduated plan procedure ("Stufenplanverfahren") in order to update the product informations of medicinal products containing calcium folinate for injection.