Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1792694
Name of medicinal product: ABACAVIR/LAMIVUDINE AUXILIA
Active substances:
Lamivudine+Abacavir
Estonian, English, Latin
ATC code: J05AR02
Dosage form: film-coated tablet
Route of administration: oral use
Strengh: 300mg+600mg
Amount in package: 30TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Abacavir/Lamivudine Auxilia is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults, adolescents and children weighing at least 25 kg (see sections 4.4 and 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.
Safety features: Yes
Summary of product characteristics (SPC):  (last updated September 1, 2020)
Package information leaflet (PIL): EST  (last updated September 1, 2020)
Labelling:  (last updated September 1, 2020)
Last imported to Estonia: June 6, 2022
Marketing authorization holder: Auxilia Pharma OÜ 
Marketing authorization number: 1008720 
Marketing authorization issued on: September 1, 2020 
Marketing authorization expires on: September 1, 2025 
Marketing authorization procedure type: Decentralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Description Additional condition
Hambaarstil on õigus välja kirjutada
Entry/Changing date: March 3, 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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