Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1792447
Active substances:
Estonian, English, Latin
ATC code: P01BA02
Dosage form: film-coated tablet
Route of administration: oral use
Strengh: 200mg
Amount in package: 60TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
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
Summary of product characteristics (SPC):  (last updated June 20, 2023)
Package information leaflet (PIL): EST  (last updated June 20, 2023)
Labelling:  (last updated May 19, 2020)
Last imported to Estonia: Never imported to Estonia
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 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: November 27, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

You can download Acrobat Reader fromhere