Components:

Ataluren

Medically reviewed by Kovalenko Svetlana Olegovna, PharmD. Last updated on 26.06.2023

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Translarna Ataluren

Name of the medicinal product

Ataluren

Qualitative and quantitative composition

Ataluren is a novel, orally administered drug that targets nonsense mutations. It is used as a treatment for Duchenne muscular dystrophy (DMD) and cystic fibrosis (CF), and has the potential to treat a number of other genetic disorders caused by nonsense mutations. On 23 May 2014 Ataluren received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). Translarna was first available in Germany, the first EU country to launch the new medicine. In August 2014, Ataluren received market authorization from the European Commission to treat patients with nonsense mutation Duchenne muscular dystrophy. A confirmatory phase III clinical trial is ongoing. The drug does not yet have approval by the US Food and Drug Administration.

Therapeutic indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.

For the treatment of cystic fibrosis and muscular dystrophy.

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