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MALARONE
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1129979
Name of medicinal product:
MALARONE
Active substances:
Proguanil+Atovaquone
Estonian
,
English
,
Latin
ATC code:
P01BB51
Dosage form:
film-coated tablet
Route of administration:
oral use
Strengh:
100mg+250mg
Amount in package:
12TK
Legal status for supply*:
Subject to medicinal prescription
Class of active substance:
Additional information:
Indication:
Prophylaxis of Plasmodium falciparum malaria in adults. Treatment of acute, uncomplicated Plasmodium falciparum malaria in adults and children weighing more than 11 kg. Note: Because Malarone is effective against drug sensitive and drug resistant P. falciparum it is especially recommended for prophylaxis and treatment of P. falciparum malaria where the pathogen may be resistant to other antimalarials. Official guidelines and local information on the prevalence of resistance to antimalarial drugs should be taken into consideration. Official guidelines will normally include WHO and public health authorities guidelines.
Safety features:
Yes
Summary of product characteristics (SPC):
(last updated February 15, 2021)
Package information leaflet (PIL):
EST
(last updated February 22, 2023)
Labelling:
(last updated December 21, 2018)
Last imported to Estonia:
November 9, 2023
Marketing authorization
Marketing authorization holder:
GlaxoSmithKline (Ireland) Limited
Marketing authorization number:
425503
Marketing authorization issued on:
December 5, 2003
Marketing authorization expires on:
Unlimited
Marketing authorization procedure type:
National
Prices
Reference price:
Under reference price:
Reference price of daily dose:
Entry/Changing date: February 22, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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