Lopinavir/Ritonavir Mylan

Lopinavir/Ritonavir Mylan can only be obtained with a prescription and treatment should be started by a doctor who is experienced in managing HIV infection. It is available as tablets (100 mg lopinavir and 25 mg ritonavir; 200 mg lopinavir and 50 mg ritonavir).

In adults and adolescents (aged 12 years and over), the recommended dose of Lopinavir/Ritonavir Mylan is two 200/50-mg tablets twice a day. This dose is also suitable for children (aged between two and 12 years) provided that they weigh more than 40 kg or have a body surface area (calculated using the child’s height and weight) over 1.4 m2. The dose for smaller children depends on the child’s body surface area and the other medicines that the child is taking.

For adults (aged 18 years or over) who are infected with HIV that is likely to respond to medicines in the same class as Lopinavir/Ritonavir Mylan (protease inhibitors) the doctor may prescribe the full daily dose of four 200/50-mg tablets as a single dose. When deciding to use once-daily dosing, the doctor should consider the fact that it might not be as effective as twice-daily dosing at keeping HIV levels low in the long term and may increase the risk of diarrhoea. For more information, see the package leaflet.

The active substances in this medicine, lopinavir and ritonavir, are protease inhibitors: they block an enzyme called protease that is involved in the replication of HIV. When the enzyme is blocked, the virus does not replicate normally, slowing down the spread of infection. In Lopinavir/Ritonavir Mylan, lopinavir provides the activity and ritonavir is used as a ‘booster’ that slows down the rate at which lopinavir is broken down by the liver. This increases the levels of lopinavir in the blood, allowing a lower dose of lopinavir to be used for the same antiviral effect.

Lopinavir/Ritonavir Mylan, taken with other HIV medicines, reduces HIV in the blood and keeps the virus at a low level. It does not cure HIV infection, but it can hold off damage to the immune system and avoid the development of infections and diseases associated with AIDS.

A risk management plan has been developed to ensure that Lopinavir/Ritonavir Mylan is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Lopinavir/Ritonavir Mylan, including the appropriate precautions to be followed by healthcare professionals and patients.

Further information can be found in the Lopinavir/Ritonavir Mylan : EPAR - Risk-management-plan summary.

The European Commission granted a marketing authorisation valid throughout the European Union for Lopinavir/Ritonavir Mylan on 14 January 2016.

For more information about treatment with Lopinavir/Ritonavir Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Because Lopinavir/Ritonavir Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

Lopinavir/Ritonavir Mylan is used in combination with other medicines to treat patients over two years of age who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). Lopinavir/Ritonavir Mylan contains the active substances lopinavir and ritonavir.

Lopinavir/Ritonavir Mylan is a ‘generic medicine’. This means that it is similar to a ‘reference medicine’ already authorised in the European Union (EU), called Kaletra.

Because Lopinavir/Ritonavir Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Kaletra. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Lopinavir/Ritonavir Mylan has been shown to have comparable quality and to be bioequivalent to Kaletra. Therefore, the CHMP’s view was that, as for Kaletra, the benefit outweighs the identified risk. The Committee recommended that Lopinavir/Ritonavir Mylan be approved for use in the EU.

Lopinavir/Ritonavir Viatris can only be obtained with a prescription and treatment should be started by a doctor who is experienced in managing HIV infection. It is available as tablets to be taken by mouth.

For more information about using Lopinavir/Ritonavir Viatris, see the package leaflet or contact your doctor or pharmacist.

The active substances in this medicine, lopinavir and ritonavir, are protease inhibitors: they block an enzyme called protease that is involved in the replication of HIV. When the enzyme is blocked, the virus does not replicate normally, slowing down the spread of infection. In Lopinavir/Ritonavir Viatris, lopinavir provides the activity and ritonavir is used as a ‘booster’ that slows down the rate at which lopinavir is broken down by the liver. This increases the levels of lopinavir in the blood, allowing a lower dose of lopinavir to be used for the same antiviral effect.

Lopinavir/Ritonavir Viatris, taken with other HIV medicines, reduces HIV in the blood and keeps the virus at a low level. It does not cure HIV infection, but it can hold off damage to the immune system and avoid the development of infections and diseases associated with AIDS.

Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Kaletra, and do not need to be repeated for Lopinavir/Ritonavir Viatris.

As for every medicine, the company provided studies on the quality of Lopinavir/Ritonavir Viatris. The company also carried out studies that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

Because Lopinavir/Ritonavir Viatris is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

The European Medicines Agency concluded that, in accordance with EU requirements, Lopinavir/Ritonavir Viatris has been shown to have comparable quality and to be bioequivalent to Kaletra. Therefore, the Agency’s view was that, as for Kaletra, the benefit outweighs the identified risk and it can be approved for use in the EU.

Lopinavir/Ritonavir Mylan received a marketing authorisation valid throughout the EU on 14 January 2016.

The name of the medicine was changed to Lopinavir/Ritonavir Viatris on 13 June 2024.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lopinavir/Ritonavir Viatris have been included in the summary of product characteristics and the package leaflet. Any additional measures in place for Kaletra also apply to Lopinavir/Ritonavir Viatris where appropriate.

As for all medicines, data on the use of Lopinavir/Ritonavir Viatris are continuously monitored. Suspected side effects reported with Lopinavir/Ritonavir Viatris are carefully evaluated and any necessary action taken to protect patients.