Register of Medicinal Products

ABACAVIR/LAMIVUDINE ACCORD

Product class:	Authorized package
Medicinal product class:	For human use
Package code:	1682995
Name of medicinal product:	ABACAVIR/LAMIVUDINE ACCORD
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:	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-B5701 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-B5701 allele.
Safety features:	Yes
Summary of product characteristics (SPC):	(last updated September 15, 2021)
Package information leaflet (PIL):	EST (last updated June 19, 2019)
Labelling:	(last updated June 19, 2019)
Last imported to Estonia:	June 9, 2023

Marketing authorization

Marketing authorization holder:	Accord Healthcare B.V.
Marketing authorization number:	908616
Marketing authorization issued on:	May 10, 2016
Marketing authorization expires on:	Unlimited
Marketing authorization procedure type:	Decentralised

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: September 14, 2023

Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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