Product class:
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Medicinal product with marketing authorization
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Medicinal product class:
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Human medicine
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Name of medicinal product:
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MALARONE PAEDIATRIC
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Active substances:
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|
ATC code:
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P01BB51
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Dosage form:
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film-coated tablet
|
Strength:
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25mg+62,5mg
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Legal status for supply*:
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Subject to medicinal prescription
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Summary of product characteristics (SPC):
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(last updated February 15, 2021)
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Package information leaflet (PIL):
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EST (last updated February 15, 2021)
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Labelling:
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(last updated December 21, 2018)
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Indication:
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Prophylaxis of Plasmodium falciparum malaria in individuals weighing 11-40 kg.
Note: For treatment of acute, uncomplicated Plasmodium falciparum malaria in individuals weighing 11-40 kg please refer to the Summary of Product Characteristics for MALARONE 250/100 mg tablets.
MALARONE may be active against Plasmodium falciparum that are resistant to one or more other antimalarial agents. Therefore, MALARONE may be particularly suitable for prophylaxis against Plasmodium falciparum infections in areas where this species is known to be commonly resistant to one or more other antimalarial agents
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.
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Safety features:
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Yes
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Marketing authorization holder:
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GlaxoSmithKline (Ireland) Limited
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Marketing authorization number:
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425603
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Marketing authorization issued on:
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December 5, 2003
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Marketing authorization expires on:
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Unlimited
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Marketing authorization procedure type:
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National
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Assessment report:
|
|
Package code
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Name of medicinal product
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Dosage form
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Package
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Legal status
|
Reimbursements
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Reference price
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Last imported
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PƤritolumaa
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Additional information
|
1129968
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MALARONE PAEDIATRIC
|
film-coated tablet
|
25mg +62,5mg 12TK
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Prescription
|
|
|
09.04.2020
|
|
|
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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