In the treatment of anaemia in patients with myelodysplastic syndromes , Aranesp was expected to work in the same way as it does in its existing indications.
Stacy Wiegman, PharmD.
On occasion, your healthcare provider may recommend Aranesp for treating something other than anemia caused by chronic kidney failure or by chemotherapy. The first study compared Aranesp with placebo (a dummy treatment) over 24 weeks. Aranesp [package insert]. It contains the active substance darbepoetin alfa. Pharmacy. Kristi Monson, PharmD; Arthur Schoenstadt, MD, Transitional Cell Carcinoma (of the Ureter and Renal Pelvis), Morphine Sulfate/Naltrexone Hydrochloride.
Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Aranesp could not have been approved for the treatment of anaemia in adult patients with myelodysplastic syndromes. is available. How Does Aranesp Work? Some people are able to be more active. But darbepoetin alfa only corrects anemia. withdrawal letter
How does darbepoetin alfa (Aranesp) work? The company informed the Agency that there are no Amgen-sponsored ongoing clinical trials with Aranesp. Committee for Medicinal Products for Human Use, Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 March 2018, Date of issue of market authorisation valid throughout the European Union (if applicable), International non-proprietary name (INN) or common name. Darbepoetin alfa is in the class of drugs known as the erythropoiesis-stimulating agents (ESAs).
Aranesp is approved to treat anemia related to chronic kidney failure in children as young as one year of age. Drug Type: Darbepoetin alfa is a biologic response modifier. On 21 February 2018, Amgen Europe B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application to add treatment of anaemia in adult patients with myelodysplastic syndromes to the existing marketing authorisation.
In some cases, health care professionals may use the trade name aranesp when referring to the generic drug name darbepoetin alfa. Could I have an allergic reaction to albumin? It is not approved to treat anemia caused by chemotherapy in children. What does "staging" of my head and neck cancer mean? The company had not yet responded to the questions at the time of the withdrawal. The United Kingdom (UK) withdrew from the European Union (EU) on 31 January 2020 and is no longer an EU Member State.
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