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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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1792458
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Name of medicinal product:
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HYDROXYCHLOROQUINE SULFATE ACCORD
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Active substances:
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ATC code:
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P01BA02
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Dosage form:
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film-coated tablet
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Route of administration:
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oral use
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Strengh:
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200mg
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Amount in package:
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90TK
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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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Adults
tablets are recommended for the treatment of rheumatoid arthritis, discoid and systemic lupus erythematosus, and photodermatoses.
This product is also indicated in adults for prevention and treatment of uncomplicated malaria caused by Plasmodium vivax, P. ovale, P. malariae and chloroquine sensitive P. falciparum.
Paediatric population (? 6 years and ? 31 kg)
Treatment of juvenile idiopathic arthritis (in combination with other therapies), discoid and systemic lupus erythematosus.
Also indicated for prevention and treatment of uncomplicated malaria, caused by Plasmodium vivax, P. malariae, P. ovale and chloroquine-sensitive P. falciparum.
Chloroquine-resistant P. falciparum, and increasingly chloroquine-resistant P. vivax, are found in many areas which limits the usefulness of hydroxychloroquine in these areas. Official guidelines and local information on the occurrence of resistance to anti-malaria agents must be observed (e.g. WHO and public health directives).
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Safety features:
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Yes
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Summary of product characteristics (SPC):
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 (last updated June 20, 2023)
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Package information leaflet (PIL):
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EST (last updated June 20, 2023)
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Labelling:
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(last updated May 19, 2020)
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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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Accord Healthcare B.V.
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Marketing authorization number:
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1005920
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Marketing authorization issued on:
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May 19, 2020
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Marketing authorization expires on:
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May 19, 2025
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Marketing authorization procedure type:
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Decentralised
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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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Entry/Changing date:
November 27, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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