BfArM - Federal Institute for Drugs and Medical Devices

Navigation and service

Search i

Search help

  • Enter one or more search terms in the search field. Upper and lower case are not relevant.
  • As soon as you have entered three letters in the search field, various search words will be suggested from which you can choose one.
  • If you are searching for a certain group of words, put these words in double quotes. The hits will then contain the words in the order you entered, e.g. "medicines for children".
  • Multiple search terms can also be combined with the Boolean operators AND and OR. When using the operator AND, the results contain the intersection of all search terms. When using the operator OR, the hits contain one of the search terms or only individual search terms. The result set is therefore significantly larger. Please note that these operators must be written in capital letters.
  • If you receive a (too) large number of hits as a result of your search, you can narrow it down by using filters. These filter options appear to the left of the search results and are subdivided into:

    • category (e.g. safety of medicinal products, medical devices, code systems)
    • format (e.g. download, risk information, DHPCs)
    • time interval (e.g. last 30 days, older than ...)
  • Selected filters can be removed individually or all at once ("Show all results").
  • By default, search results are sorted by relevance, but they can also be sorted chronologically ("Latest entries first" or "Oldest entries first").

Enter search term

442 results

Results per page: 10 20 30

Dear Doctor Letter (Rote-Hand-Brief) on Revlimid® (lenalidomide): New important information on reactivation of virus infections PDF, 335KB, File is accessible Date: 08. November 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: lenalidomide

The company Celgene GmbH is circulating information that cases of virus reactivation after treatment with lenalidomide have been reported.

Information Letter on acitretin and teratogenicity: Extension of the contraception period and the prohibition of blood donation after end of therapy PDF, 98KB, File is accessible Date: 08. November 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: acitretin

In an Information Letter, the companies Dermapharm and Puren Pharma point out the extension of the contraception period and the prohibition of blood donation up to three years after discontinuation of therapy with acitretin.

Information letter on emergency hormonal contraceptives (e.g. Postinor®): New recommendations for women taking CYP3A4 inducers PDF, 93KB, File does not meet accessibility standards Date: 26. September 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: levonorgestrel

The company Gedeon Richter Pharma GmbH is circulating new recommendations for women taking liver enzyme inducers. Active substances that trigger such an induction include e.g. preparations containing St. John's wort, rifampicin, certain HIV

Dear Doctor Letter (Rote-Hand-Brief) on GlucaGen® HypoKit (glucagon hydrochloride): Batch recall due to quality defect Date: 07. September 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: glucagon hydrochloride

The company Novo Nordisk Pharma GmbH is circulating information that 3 batches of the GlucaGen® HypoKit are being recalled in Germany.

Renewed information on Erwinase® 10,000 IU/vial (crisantaspase): Shortage and instructions for use for further batches 174aG116 and 177aG116 PDF, 303KB, File is accessible Date: 26. August 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: crisantaspase

In connection with the import of Erwinase® from The United Kingdom, the company Jazz Pharmaceuticals Germany GmbH is circulating information on the fact that a 5 μm filter needle is to be used when administering batches 174aG116 and 177aG116.

Dear Doctor Letter (Rote-Hand-Brief) on Zydelig® (Idelalisib): Updated recommendations following conclusion of the safety data evaluation PDF, 600KB, File is accessible Date: 23. August 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: idelalisib

The company Gilead Sciences GmbH is circulating information on the updated indication of idelalisib as first-line treatment of patients with chronic lymphocytic leukaemia (CLL) and on risk minimisation measures for prevention of infections.

Arcoxia® (etoricoxib): Altered dosage recommendations for patients with rheumatoid arthritis and ankylosing spondylitis (Bekhterev's disease) PDF, 902KB, File is accessible Date: 19. July 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: etoricoxib

The company MSD is circulating information on altered dosage recommendations for the medicinal product Arcoxia®.

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.

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.

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.

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.

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

.

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.

Information Letter on SGLT2 inhibitors: Updated information on the risk of diabetic ketoacidosis PDF, 192KB, File is accessible Date: 14. March 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: canagliflozin, dapagliflozin, empagliflozin

After completion of the European safety review by the CHMP, the pharmaceutical entrepreneurs concerned are circulating information on the recommendation to minimise the risk of diabetic ketoacidosis.

Dear Doctor Letter (Rote-Hand-Brief) on Myfortic® (mycophenolate): Serious risk of teratogenicity – reinforced advice on pregnancy prevention for women and men PDF, 180KB, File is accessible Date: 01. March 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: mycophenolate sodium

The company Novartis Pharma AG is circulating information in a Dear Doctor Letter that the advice regarding pregnancy prevention when using Myfortic® has been reinforced considerably.

Dear Doctor Letter (Rote-Hand-Brief) on Fingolimod (Gilenya®): Risks related to the effects on the immune system PDF, 1MB, File is accessible Date: 20. January 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fingolimod

The company Novartis Pharma GmbH is circulating information on recent product information changes in relation to immunosuppressive effects.

Dear Doctor Letter (Rote-Hand-Brief) on Tarceva® (erlotinib): Restriction of indication PDF, 85KB, File is accessible Date: 14. January 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: erlotinib

The company Roche Pharma AG is circulating a Dear Doctor Letter with information on restrictions regarding the indications of Tarceva®.

Dear Doctor Letter (Rote-Hand-Brief) on Ampicillin+Sulbactam-ratiopharm® 1000/500 mg p.i. vials and Ampicillin+Sulbactam-ratiopharm® 2000/1000 mg p.i. vials: New information for use PDF, 133KB, File is accessible Date: 08. January 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ampicillin, sulbactam

The company Ratiopharm GmbH is circulating information that as a precautionary measure it is currently absolutely necessary to use a particle filter when administering the product.

Dear Doctor Letter (Rote-Hand-Brief) on Viekirax® (ombitasvir, paritaprevir, ritonavir) with or without Exviera® (dasabuvir): Important new safety information regarding liver function PDF, 444KB, File is accessible Date: 04. January 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ombitasvir, paritaprevir, ritonavir, dasabuvir

The company AbbVie Deutschland GmbH is circulating information on measures to reduce the risk of liver damage.

Information letters on Insuman® Basal and Insuman® Comb 25 - suspension for injection in 3-ml cartridges and Solo-Star® in pre-filled pens: Shortage Date: 01. December 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: insulin human

The company Sanofi-Aventis Deutschland GmbH is sending out letters with the information that as of December 2015 the medicinal products Insuman® Basal and Insuman® Comb 25 will not be available at all or only limitedly due to capacity issues …

Dear Doctor Letter (Rote-Hand-Brief) on Tecfidera® (dimethyl fumarate): New measures to reduce the risk of progressive multifocal leukoencephalopathy PML - enhanced monitoring and stopping rules PDF, 715KB, File is accessible Date: 24. November 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dimethyl fumarate

The company Biogen Idec GmbH is circulating information on important new measures to minimise the risk of progressive multifocal leukoencephalopathy (PML) during treatment with Tecfidera®.

Dear Doctor Letter (Rote-Hand-Brief) on Fumaderm® initial / Fumaderm® (fumaric acid ester): Measures to reduce the risk of progressive multifocal leukoencephalopathy (PML)
PDF, 713KB, File is accessible
Date: 24. November 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fumaric acid ester

After a hearing under the graduated plan procedure ("Stufenplanverfahren"), stage II and conclusion of the variation worksharing procedure, the company Biogen Idec GmbH is circulating information on measures to reduce the risk of progressive …

Dear Doctor Letter (Rote-Hand-Brief) on Thalidomide Celgene® (Thalidomide): Reduction of starting dose when combined with melphalan in patients over 75 years of age PDF, 422KB, File is accessible Date: 10. November 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Thalidomid

The company Celgene GmbH is circulating information that the starting dose of Thalidomide Celgene should be reduced when combined with melphalan and prednisone (MPT) in patients over 75 years of age with untreated multiple myeloma.

Dear Doctor Letter (Rote-Hand-Brief) on CellCept®: Serious risk of teratogenicity – strengthened advice on pregnancy prevention for women and men Date: 10. November 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: mycophenolate mofetil

The company Roche Pharma is circulating information that the advice regarding pregnancy prevention when using CellCept® has been strengthened considerably.