Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1707117
Name of medicinal product: ABACAVIR/LAMIVUDINE MYLAN PHARMA
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 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 March 31, 2022)
Package information leaflet (PIL): EST  (last updated May 12, 2022)
Labelling:  (last updated May 17, 2019)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Mylan Ireland Limited 
Marketing authorization number: 974818 
Marketing authorization issued on: December 5, 2018 
Marketing authorization expires on: December 5, 2023 
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: May 12, 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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