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Search results for m root_notes_note in Note (approximate match)
Status:
Possibly Marketed Outside US
Source:
BLA125737
(2021)
Source URL:
First approved in 2021
Source:
BLA125737
Source URL:
Class:
PROTEIN
Status:
Other
Class:
POLYMER
Status:
Possibly Marketed Outside US
Source:
M020
(2020)
Source URL:
First approved in 2009
Source:
21 CFR 352
Source URL:
Class:
POLYMER
Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2001)
Source URL:
First approved in 2001
Source:
21 CFR 352
Source URL:
Class:
POLYMER
Status:
Other
Class:
STRUCTURALLY DIVERSE
Status:
Possibly Marketed Outside US
Source:
BLA103189
(2009)
Source URL:
First approved in 2009
Source:
BLA103189
Source URL:
Class:
STRUCTURALLY DIVERSE
Status:
Other
Class:
G1 SPECIFIED SUBSTANCE
Status:
US Approved Rx
(2020)
Source:
NDA213036
(2020)
Source URL:
First approved in 2020
Source:
NDA213036
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Artenimol (dihydroartemisinin) is a derivate of antimalarial compound artemisinin. Artenimol (dihydroartemisinin) is able to reach high concentrations within the parasitized erythrocytes. Its endoperoxide bridge is thought to be essential for its antimalarial activity, causing free-radical damage to parasite membrane systems including:
• Inhibition of falciparum sarcoplasmic-endoplasmic reticulum calcium ATPase, • Interference with mitochondrial electron transport • Interference with parasite transport proteins • Disruption of parasite mitochondrial function. Dihydroartemisinin in combination with piperaquine tetraphosphate (Eurartesim, EMA-approved in 2011) is indicated for the treatment of uncomplicated Plasmodium falciparum malaria. The formulation meets WHO recommendations, which advise combination treatment for Plasmodium falciparum malaria to reduce the risk of resistance development, with artemisinin-based preparations regarded as the ‘policy standard’. However, experimental testing demonstrates that, due to its intrinsic chemical instability, dihydroartemisinin is not suitable to be used in pharmaceutical formulations. In addition, data show that the currently available dihydroartemisinin preparations fail to meet the internationally accepted stability requirements.
