Land: Oeganda
Taal: Engels
Bron: National Drug Authority
ARTESUNATE + AMODIAQUINE
GUILIN PHARMACEUTICALS CO.LTD
ARTESUNATE + AMODIAQUINE
100 MG + 270 MG
ORAL SOLID ORDINARY TABLETS
1.0X20.0X3.0 TABLET BLISTER,1.0X20.0X6.0 TABLET BLISTER,1.0X25.0X3.0 TABLET BLISTER,1.0X25.0X6.0 TABLET BLISTER
2011-07-01
ML ASAQ winthrop – August 2010-V1 Page 1 of 11 ARTESUNATE AMODIAQUINE WINTHROP 25 MG/67.5 MG, TABLET ARTESUNATE AMODIAQUINE WINTHROP 50 MG/135 MG, TABLET ARTESUNATE AMODIAQUINE WINTHROP 100 MG/270 MG, TABLET NAME OF THE MEDICINAL PRODUCT _ARTESUNATE AMODIAQUINE WINTHROP_ ® 25MG/67.5MG TABLETS Artesunate, amodiaquine _ARTESUNATE AMODIAQUINE WINTHROP_ ® 50MG/135MG TABLETS Artesunate, amodiaquine _ _ _ARTESUNATE AMODIAQUINE WINTHROP_ ® 100MG/270MG TABLETS Artesunate, amodiaquine QUALITATIVE AND QUANTITATIVE COMPOSITION _ARTESUNATE AMODIAQUINE WINTHROP _ is a fixed dose combination of amodiaquine and artesunate. Each ARTESUNATE AMODIAQUINE WINTHROP 25mg/67.5mg tablet contains 25 milligrams of artesunate 67.5 milligrams of amodiaquine _ (as hydrochloride)_ Each ARTESUNATE AMODIAQUINE WINTHROP 50mg/135mg tablet contains 50 milligrams of artesunate and 135 milligrams of amodiaquine _ (as hydrochloride)_ . Each ARTESUNATE AMODIAQUINE WINTHROP 100mg/270mg tablet contains 100 milligrams of artesunate and 270 milligrams of amodiaquine _ (as hydrochloride)_ . PHARMACEUTICAL FORM Tablets : ARTESUNATE AMODIAQUINE WINTHROP 25mg/67.5mg is a round bilayer tablet : one layer is yellow coloured, the other one is white to slightly yellow, with score line, engraved on one side “AS” and on the other side “25”. ARTESUNATE AMODIAQUINE WINTHROP 50mg/135mg is a round bilayer tablet : one layer is yellow coloured, the other one is white to slightly yellow, with score line, engraved on one side “AS” and on the other side “50”. ARTESUNATE AMODIAQUINE WINTHROP 100mg/270mg is a round bilayer tablet : one layer is yellow coloured, the other one is white to slightly yellow, with score line, engraved on one side “AS” and on the other side “100”. The tablets may be mottled but it does not alter the safety and effectiveness of the product. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. ML ASAQ winthrop – August 2010-V1 Page 2 of 11 CLINICAL PARTICULARS THERAPEUT Lees het volledige document