Product class:
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Authorized package
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Medicinal product class:
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For human use
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Package code:
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1423820
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Name of medicinal product:
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APTIVUS
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Active substances:
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ATC code:
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J05AE09
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Dosage form:
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oral solution
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Route of administration:
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oral use
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Strengh:
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100mg 1ml
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Amount in package:
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95ml 1TK
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Legal status for supply*:
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Subject to medicinal prescription
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Class of active substance:
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Additional information:
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Indication:
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Aptivus, co-administered with low dose ritonavir, is indicated for combination antiretroviral treatment
of HIV-1 infection in highly pre-treated children from 2 to 12 years of age with virus resistant to
multiple protease inhibitors. Aptivus should only be used as part of an active combination
antiretroviral regimen in patients with no other therapeutic options (see sections 4.4 and 5.1).
In deciding to initiate treatment with Aptivus, co-administered with low dose ritonavir, careful
consideration should be given to the treatment history of the individual patient and the patterns of
mutations associated with different agents. Genotypic or phenotypic testing (when available) and
treatment history should guide the use of Aptivus. Initiation of treatment should take into account the
combinations of mutations which may negatively impact the virological response to Aptivus, coadministered
with low dose ritonavir (see section 5.1).
|
Safety features:
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Yes
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Summary of product characteristics (SPC):
|
|
Package information leaflet (PIL):
|
EST
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Labelling:
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Last imported to Estonia:
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Never imported to Estonia
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Marketing authorization holder:
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Boehringer Ingelheim International GmbH
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Marketing authorization number:
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EU/1/05/315
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Marketing authorization issued on:
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June 23, 2009
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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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Centralised
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Reference price:
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|
Under reference price:
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Reference price of daily dose:
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Description
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Additional condition
|
Hambaarstil on õigus välja kirjutada
|
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Entry/Changing date:
August 4, 2015
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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