Register of Medicinal Products

ABACAVIR/LAMIVUDINE MYLAN

Product class:	Authorized package
Medicinal product class:	For human use
Package code:	1733543
Name of medicinal product:	ABACAVIR/LAMIVUDINE MYLAN
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 December 5, 2022)
Package information leaflet (PIL):	EST (last updated February 23, 2022)
Labelling:	(last updated September 28, 2021)
Last imported to Estonia:	July 2, 2019

Marketing authorization

Marketing authorization holder:	Mylan Pharmaceuticals Limited
Marketing authorization number:	962918
Marketing authorization issued on:	April 3, 2018
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: December 5, 2022

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

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