ABACAVIR/LAMIVUDINE SANDOZ
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1672488
Name of medicinal product:
ABACAVIR/LAMIVUDINE SANDOZ
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:
60TK
Legal status for supply*:
Subject to medicinal prescription
Class of active substance:
Additional information:
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
Summary of product characteristics (SPC):
(last updated 31 March 2022)
Package information leaflet (PIL):
EST
(last updated 31 March 2022)
Labelling:
(last updated 31 March 2022)
Last imported to Estonia:
Never imported to Estonia
Marketing authorization
Marketing authorization holder:
Sandoz Pharmaceuticals d.d.
Marketing authorization number:
920616
Marketing authorization issued on:
11 October 2016
Marketing authorization expires on:
Unlimited
Marketing authorization procedure type:
Decentralised
Prices
Reference price:
Under reference price:
Reference price of daily dose:
Perscription conditions and restrictions
Description
Additional condition
Hambaarstil on õigus välja kirjutada
Entry/Changing date: 28 November 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription