Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: ABACAVIR/LAMIVUDINE SANDOZ
Active substances:
Estonian, English, Latin
ATC code: J05AR02
Dosage form: film-coated tablet
Strength: 300mg+600mg
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):  (last updated March 31, 2022)
Package information leaflet (PIL): EST  (last updated March 31, 2022)
Labelling:  (last updated March 31, 2022)
Indication: {[Nationally completed name]} 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
Marketing authorization holder: Sandoz Pharmaceuticals d.d. 
Marketing authorization number: 920616 
Marketing authorization issued on: October 11, 2016 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Decentralised 
Assessment report:   
Description Additional condition
Hambaarstil on õigus välja kirjutada
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported Additional information
1672477  ABACAVIR/LAMIVUDINE SANDOZ  film-coated tablet  300mg +600mg 30TK  Prescription         
1672488  ABACAVIR/LAMIVUDINE SANDOZ  film-coated tablet  300mg +600mg 60TK  Prescription         
1672499  ABACAVIR/LAMIVUDINE SANDOZ  film-coated tablet  300mg +600mg 90TK  Prescription         
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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