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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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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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Strength:
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200mg
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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 20 June 2023)
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Package information leaflet (PIL):
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EST (last updated 20 June 2023)
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Labelling:
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(last updated 19 May 2020)
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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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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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19 May 2020
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Marketing authorization expires on:
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19 May 2025
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Marketing authorization procedure type:
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Decentralised
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Assessment report:
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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
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Reimbursements
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Reference price
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Last imported
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PƤritolumaa
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Additional information
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1792414
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HYDROXYCHLOROQUINE SULFATE ACCORD
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film-coated tablet
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200mg 20TK
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Prescription
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1792425
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HYDROXYCHLOROQUINE SULFATE ACCORD
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film-coated tablet
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200mg 30TK
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Prescription
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1792436
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HYDROXYCHLOROQUINE SULFATE ACCORD
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film-coated tablet
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200mg 50TK
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Prescription
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1792447
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HYDROXYCHLOROQUINE SULFATE ACCORD
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film-coated tablet
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200mg 60TK
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Prescription
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1792458
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HYDROXYCHLOROQUINE SULFATE ACCORD
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film-coated tablet
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200mg 90TK
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Prescription
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1792469
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HYDROXYCHLOROQUINE SULFATE ACCORD
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film-coated tablet
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200mg 100TK
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Prescription
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Legal status for supply – medicinal product on medical prescription or not subject to medical prescription