Abacavir Mylan 300 mg Film-coated Tablets
4.1 Therapeutic indications
Abacavir Mylan is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults, adolescents and children (see sections 4.4 and 5.1).
The demonstration of the benefit of abacavir is mainly based on results of studies performed with a twice daily regimen, in treatment-naïve adult patients on combination therapy (see section 5.1).
Before initiating treatment with abacavir, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin (see section 4.4). Abacavir should not be used in patients known to carry the HLA-B*5701 allele.
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Drugs appearing in this section are approved by UK Medicines & Healthcare Products Regulatory Agency (MHRA), & the European Medicines Agency (EMA).