Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: HYDROXYCHLOROQUINE SULFATE ACCORD
Active substances:
Hydroxychloroquine
Estonian, English, Latin
ATC code: P01BA02
Dosage form: film-coated tablet
Strength: 200mg
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):  (last updated May 19, 2020)
Package information leaflet (PIL): EST  (last updated May 19, 2020)
Labelling:  (last updated May 19, 2020)
Indication: 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).
Safety features: Yes
Marketing authorization holder: Accord Healthcare B.V. 
Marketing authorization number: 1005920 
Marketing authorization issued on: May 19, 2020 
Marketing authorization expires on: May 19, 2025 
Marketing authorization procedure type: Decentralised 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported Additional information
1792414  HYDROXYCHLOROQUINE SULFATE ACCORD  film-coated tablet  200mg 20TK  Prescription         
1792425  HYDROXYCHLOROQUINE SULFATE ACCORD  film-coated tablet  200mg 30TK  Prescription         
1792436  HYDROXYCHLOROQUINE SULFATE ACCORD  film-coated tablet  200mg 50TK  Prescription         
1792447  HYDROXYCHLOROQUINE SULFATE ACCORD  film-coated tablet  200mg 60TK  Prescription         
1792458  HYDROXYCHLOROQUINE SULFATE ACCORD  film-coated tablet  200mg 90TK  Prescription         
1792469  HYDROXYCHLOROQUINE SULFATE ACCORD  film-coated tablet  200mg 100TK  Prescription         
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

You can download Acrobat Reader fromhere