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Dear Doctor Letter (Rote-Hand-Brief) on new contraindications of Saccharomyces boulardii (Saccharomyces cerevisiae HANSEN CBS 5926) in seriously ill or immunocompromised patients Date: 22. January 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Saccharomyces boulardii

The marketing authorisation holders of the medicinal products concerned issue information on rare cases of fungemia that led to death in seriously ill patients.

Information Letter on noradrenaline PDF, 3MB, File is accessible Date: 17. January 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: noradrenaline

The company Aguettant issues information on the marketing of a solution for infusion containing noradrenaline in two new ready-for-use strengths.

Information Letter on Haldol® (tablets, oral drops, solution, solution for injection) and Haldol Decanoat Depot®: clarification regarding Janssen-Cilag GmbH's Dear Doctor Letter of 21 December 2017 PDF, 261KB, File is accessible Date: 15. January 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: haloperidol

Due to questions regarding the recently circulated Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing haloperidol, the company Janssen-Cilag GmbH (Haldol®-Janssen) would like to clarify the aspects raised most frequently.

Dear Doctor Letter (Rote-Hand-Brief) on contrast media containing gadolinium: updated recommendations for use PDF, 388KB, File is accessible Date: 10. January 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: gadolinium

The marketing authorisation holders concerned are circulating information on indications confirmed by the European Medicines Agency (EMA) regarding low levels of gadolinium deposition in the brain following administration of contrast media …

Dear Doctor Letter (Rote-Hand-Brief) on Haldol® and Haldol Decanoat Depot® (haloperidol): changes in the indications and posology PDF, 689KB, File is accessible Date: 22. December 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: haloperidol

The company Janssen-Cilag wishes to inform that the European Medicines Agency (EMA) has conducted a procedure to harmonise the SmPCs, labelling and package leaflets of preparations containing haloperidol.

Dear Doctor Letter (Rote-Hand-Brief) on Eligard® (leuprorelin acetate): medication errors due to overtightening of the safety needle PDF, 559KB, File is accessible Date: 14. December 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: leuprorelin acetate

The company Astellas is circulating information on medication errors reported in connection with leakage of the medicinal product from the syringe..

Dear Doctor Letter (Rote-Hand-Brief) on Radium 223 dichloride (Xofigo®): increased risk of death and fractures in a randomised clinical trial with Xofigo® used in combination with abiraterone acetate and prednisolone/prednisone PDF, 36KB, File is accessible Date: 12. December 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: radium 223 dichloride

The company Bayer is circulating information on an increased incidence of deaths and fractures in a randomised clinical trial (15396/ERA-223 study) in patients with chemotherapy-naϊve castration-resistant prostate cancer (CRPC) receiving …

Dear Doctor Letter (Rote-Hand-Brief) on cladribine (Litak®, Leustatin®): changes in the product informations due to the risk of progressive multifocal leukoencephalopathy (PML) PDF, 101KB, File is accessible Date: 04. December 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: cladribine

The companies Lipomed GmbH and Janssen-Cilag GmbH are circulating information on the risk of progressive multifocal leukoencephalopathy (PML) associated with cladribine therapy which can occur up to several years after treatment with cladribine.

Dear Doctor Letter (Rote-Hand-Brief) on misoprostol (Misodel®): reports on excessive uterine tachysystole PDF, 409KB, File is accessible Date: 27. November 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: misoprostol

The company Ferring Arzneimittel GMBH is circulating information on reports of excessive uterine tachysystole that will possibly not subside with the use of tocolysis.

Dear Doctor Letter (Rote-Hand-Brief) on Gilenya®: new contraindications in patients with cardiac disorders PDF, 426KB, File is accessible Date: 07. November 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fingolimod

The company Novartis is circulating information on new contraindications in patients with cardiac disorders.

Dear Doctor Letter (Rote-Hand-Brief) on human Epoetins: new warnings on severe cutaneous adverse reactions PDF, 217KB, File is accessible Date: 04. October 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: epoetins

The marketing authorisation holders of all human epoetins are circulating information on cases of drug-induced Stevens Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), some of which were fatal.

Information letter on Dacogen® (decitabine): changes regarding instructions for reconstitution and dilution of Dacogen® 50 MG, powder for concentrate for solution for infusion PDF, 485KB, File is accessible Date: 08. September 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: decitabin

The company Janssen is circulating information that the reconstituted solution of Dacogen® must be diluted to a final concentration in the range 0.15 to 1.0 MG/ML in order to comply with the updated Chapter 5.1.10 of the European Pharmacopoeia.

Dear Doctor Letter (Rote-Hand-Brief) on Levact® (bendamustine): increased mortality observed in recent clinical studies with bendamustine PDF, 506KB, File is accessible Date: 29. August 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: bendamustine

The company Astellas is circulating information that an increased mortality was observed in recent clinical studies when bendamustine was used in non-approved combination treatments or outside the approved indications. Fatal toxicities were …

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.

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 …

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 …

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 …

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.

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 …

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 …

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.

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.

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 …

Information Letter on Kyprolis® 30 mg vial (carfilzomib): Recall due to possible cracks in the glass of the vials PDF, 29KB, File is accessible Date: 21. December 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: carfilzomib

The company Amgen is circulating information on a voluntary recall of the medicinal product Kyprolis® 30 mg vial.

Information letter on Ammonaps® (sodium phenylbutyrate) tablets and granules: Treatment only if no alternative is available
PDF, 422KB, File is accessible
Date: 13. December 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: sodium phenylbutyrate

In view of failings found in the manufacturing site of Ammonaps® (sodium phenylbutyrate) the company Swedish Orphan Biovitrum International AB (Sobi) is circulating information on temporary precautionary measures regarding treatment with …