狄诺塞麦是在什么时候上市的?
It is approved for the prevention of bone-related events in solid tumor bone metastases, but not for the prevention of bone-related events in patients with multiple myeloma. It is approved for use in adults or bone-mature adolescents with giant cell tumors of bone that are unresectable or where surgical resection may cause serious complications. It is approved for use in hypercalcemia of malignant tumors.
So when was denosumab launched?
When denosumab was released:
On May 28, 2010, the European Commission approved denosumab for the treatment of bone loss associated with hormone suppression in postmenopausal women with osteoporosis and prostate cancer. It can also be used in patients who are currently ineffective or intolerant to other treatments to reduce the risk of fractures. Denosumab was approved for the first time in 27 EU member states, as well as Norway, Iceland, and Liechtenstein. In June of the same year, denosumab was approved by the FDA for marketing.
On May 27, 2019, Amgen China announced that Angavir (English trade name:
In addition, the most common adverse reactions of denosumab reported in clinical trials were back pain (34.7%), limb pain (11.7%), musculoskeletal pain (7.6%), hypercholesterolemia (7.2%), and cystitis (5.9%). The most common adverse reactions leading to discontinuation were breast cancer, back pain, and constipation.
Other common adverse reactions include: anemia 3.3%, angina pectoris 2.6%, atrial fibrillation 2.0%, dizziness 5.0%, abdominal pain 3.3%, flatulence 2.2%, gastroesophageal reflux disease 2.1%, peripheral edema 4. 9%, weakness 2.3%, upper respiratory tract infection 4.9%, pneumonia 3.9%, pharyngitis 2.3%, herpes zoster 2.0%, spinal osteoarthritis 2.1%, sciatica 4.6%, insomnia 3.2%, rash 2.5%, and pruritus 2.2%.
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