Herceptin - European Medicines Agency - Divorce
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Herceptin
What is Herceptin used for? Herceptin is used to treat the following types of cancer: • early breast cancer (when the cancer has spread within the breast or to the glands under the arm but not to other parts of the body) after surgery chemotherapy (medicines to treat cancer) and radiotherapy (treatment with radiation) if applicable |
Does Herceptin need a marketing authorisation?
The CHMP decided that Herceptin’s benefits are greater than its risks and recommended that it be given marketing authorisation. The European Commission granted a marketing authorisation valid throughout the European Union for Herceptin on 28 August 2000.
How is Herceptin used to treat breast cancer?
Herceptin is licensed to treat early HER2-positive breast cancer, following surgery, chemotherapy and radiotherapy (if applicable). Herceptin may also be given at the same time as the chemotherapy medicines docetaxel and carboplatin.
Where can I find the epar for Herceptin?
The European Commission granted a marketing authorisation valid throughout the European Union for Herceptin on 28 August 2000. The full EPAR for Herceptin can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Who will be given Herceptin?
People who have already had at least two courses of chemotherapy will be given Herceptin on its own. Postmenopausal women with hormone sensitive cancer will be given Herceptin with an aromatase inhibitor such as anastrazole. Stomach cancer that has large amounts of HER2 on its cells is known as HER2-positive stomach cancer.
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High-cost cancer drugs likely to be approved by the Food. 107 and Drug Administration (FDA) and EMEA 2007-2010. Table 8-1. Population coverage |
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