What is Atazanavir Mylan and what is it used for?
Atazanavir Mylan is an HIV medicine used to treat patients with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). It is used together with low dose ritonavir and other antiviral medicines to treat patients from six years of age.
Atazanavir Mylan should only be prescribed by your doctor after you have considered the medicines taken by the patient and have carried out tests to determine the probability that the virus reacts to Atazanavir Mylan. It is not expected that the medicine will have effect in patients who do not have many medicines belonging to the same class as Atazanavir Mylan (protease inhibitors).
Atazanavir Mylan contains the active substance atazanavir.
Atazanavir Mylan is a "generic medicine". This means that Atazanavir Mylan is similar to a 'reference medicine' already authorized in the European Union (EU) called Reyataz. For more information on generic medicines, see the questions and answers by clicking here.
How is Atazanavir Mylan used?
Atazanavir Mylan is available as capsules (150 mg, 200 mg and 300 mg). The medicine can only be obtained with a prescription and treatment should be started by a doctor experienced in treating HIV infection.
For adults, the recommended dose is 300 mg once a day. In younger patients the dosage of Atazanavir Mylan depends on body weight. Each dose should be taken with food.
Atazanavir Mylan is usually given with ritonavir to enhance its effect. However, in certain situations the doctor may consider interrupting ritonavir administration in adults.
How does Atazanavir Mylan work?
The active substance in Atazanavir Mylan, atazanavir, is a protease inhibitor. It blocks an enzyme called protease, which the virus needs to reproduce. Blocking the enzyme prevents the virus from reproducing and the spread of infection slows down. Usually, a small dose of another medicine, ritonavir, is given to boost its effect. Its action consists in slowing down the assimilation of atazanavir, thus increasing its concentration in the blood. This allows a lower dosage of atazanavir to be used with the same antiviral effect. Taken in combination with other antiviral medicines, Atazanavir Mylan reduces the amount of HIV in the blood and keeps it at a low level. Atazanavir Mylan does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
What benefit has Atazanavir Mylan shown during the studies?
Because Atazanavir Mylan is a generic medicine, studies in patients have been limited to tests to determine its bioequivalence to the reference medicine, Reyataz. Two medicines are bioequivalent when they produce the same levels of active ingredient in the body.
Because Atazanavir Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are considered to be the same as those of the reference medicine.
What are the risks associated with Atazanavir Mylan?
Because Atazanavir Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are considered to be the same as those of the reference medicine.
Why has Atazanavir Mylan been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Atazanavir Mylan has been shown to have comparable quality and to be bioequivalent to Reyataz. Therefore, the CHMP considered that, as in the case of Reyataz, the benefits outweigh the identified risks and recommended to approve the use of Atazanavir Mylan in the EU.
What measures are being taken to ensure the safe and effective use of Atazanavir Mylan?
Recommendations and precautions to be followed by healthcare professionals and patients for Atazanavir Mylan to be used safely and effectively have been included in the summary of product characteristics and the package leaflet
More information on Atazanavir Mylan
In summer 2016, the European Commission issued a marketing authorization for Atazanavir Mylan, valid throughout the European Union.
For the full EPAR version of Atazanavir Mylan, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Atazanavir Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. The full EPAR of the reference medicine is also available on the Agency's website.
