"Rote-Hand-Briefe" (equivalent to Dear Doctor Letters) and Information Letters from the year 2009
Here you will find Information Letters and so-called "Rote-Hand-Briefe" sent out by pharmaceutical companies informing healthcare experts about newly identified major drug-associated risks and measures to reduce them.
The information published here only applies to drugs which are in the BfArM's responsibility.
For "Rote-Hand-Briefe" and Information Letters published by the Paul-Ehrlich-Institute for vaccines and biomedical products please click here.
The documents listed below are available in German only.
| Title | Date | Download |
|---|---|---|
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Rote-Hand-Brief on Fluorescein Alcon®10% Active substance: fluoresceine sodium Alcon Pharma GmbH recalls batches 160621F to 165639F in Germany. A Rote-Hand-Brief with attachment will be circulated |
2009.12.15 |  download (file size: 2 MB) |
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Rote-Hand-Brief on Fluorescein Alcon®10% Active substance: fluoresceine sodium The Institute for Drugs and Medical Devices (BfArM) advises the strict observance of the updated warnings and precautions in the expert information (SPC) on Fluorescein Alcon® 10%. A Rote-Hand-Brief (Dear Doctor Letter) concerning the changes will be circulated.
|
2009.11.02 | download (file size: 1 MB) |
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Rote-Hand-Brief on Intelence® Active substance: etravirine The Institute for Drugs and Medical Devices (BfArM) advises the urgent observance of updated warnings and precautions in expert information (SPC). A Rote-Hand-Brief (Dear Doctor Letter) dealing with the changes will be circulated. |
2009.10.19 | download (file size: 143 KB) |
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Information Letter on Tasigna® Active substance: nilotinib The Federal Institute for Drugs and Medical Devices (BfArM) requests consideration of the Information letter concerning the medicinal product Tasigna® (active substance: nilotinib) |
2009.09.15 | download (file size: 915 KB) |