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{{Short description|Combination drug}} | |||
{{Advert|date=January 2011}} | |||
{{Drugbox | {{Drugbox | ||
| Verifiedfields = changed | |||
⚫ | | verifiedrevid = |
||
| Watchedfields = changed | |||
⚫ | | verifiedrevid = 457619723 | ||
<!--Combo data--> | <!--Combo data--> | ||
| type = combo | | type = combo | ||
| component1 = Artemether | | component1 = Artemether | ||
| class1 = ] | | class1 = ] | ||
| component2 = Lumefantrine | | component2 = Lumefantrine | ||
| class2 = ] | | class2 = ] | ||
<!--Clinical data--> | <!--Clinical data--> | ||
| tradename = | | tradename = Coartem, Riamet, Falcynate-LF | ||
| Drugs.com = {{drugs.com|monograph|artemether-and-lumefantrine}} | |||
| MedlinePlus = a609024 | |||
| |
| MedlinePlus = a609024 | ||
| |
| pregnancy_AU = D | ||
| pregnancy_US = C | |||
| pregnancy_category = |
| pregnancy_category = | ||
| legal_AU = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled--> | |||
| legal_CA = <!-- Schedule I, II, III, IV, V, VI, VII, VIII --> | | legal_AU = S4 | ||
| legal_CA = <!-- Schedule I, II, III, IV, V, VI, VII, VIII --> | |||
| legal_UK = <!-- GSL, P, POM, CD, or Class A, B, C --> | | legal_UK = <!-- GSL, P, POM, CD, or Class A, B, C --> | ||
| legal_US |
| legal_US = Rx-only | ||
| legal_status |
| legal_status = | ||
| routes_of_administration = |
| routes_of_administration = By mouth | ||
<!--Identifiers--> | <!--Identifiers--> | ||
| CAS_number = 141204-94-6 | |||
| ATC_prefix = P01 | | ATC_prefix = P01 | ||
| ATC_suffix = BF01 | | ATC_suffix = BF01 | ||
| ChemSpiderID_Ref = {{chemspidercite|correct|chemspider}} | | ChemSpiderID_Ref = {{chemspidercite|correct|chemspider}} | ||
| ChemSpiderID = 21106282 | | ChemSpiderID = 21106282 | ||
<!--Chemical data--> | <!--Chemical data--> | ||
| smiles = CCCCN(CCCC)CC(O)c4cc(Cl)cc3c4c1ccc(Cl)cc1\C3=C\c2ccc(Cl)cc2.C1CC3C42OO(C)(CC12)O4O(OC)3C | |||
| InChI = 1/C30H32Cl3NO.C16H26O5/c1-3-5-13-34(14-6-4-2)19-29(35)28-18-23(33)17-27-25(15-20-7-9-21(31)10-8-20)26-16-22(32)11-12-24(26)30(27)28;1-9-5-6-12-10(2)13(17-4)18-14-16(12)11(9)7-8-15(3,19-14)20-21-16/h7-12,15-18,29,35H,3-6,13-14,19H2,1-2H3;9-14H,5-8H2,1-4H3/b25-15-;/t;9-,10-,11+,12+,13+,14-,15-,16?/m.1/s1 | |||
| InChIKey = ZVAQGQOEHFIYMQ-NWQBEBBQBG | |||
| StdInChI_Ref = {{stdinchicite|correct|chemspider}} | |||
| StdInChI = 1S/C30H32Cl3NO.C16H26O5/c1-3-5-13-34(14-6-4-2)19-29(35)28-18-23(33)17-27-25(15-20-7-9-21(31)10-8-20)26-16-22(32)11-12-24(26)30(27)28;1-9-5-6-12-10(2)13(17-4)18-14-16(12)11(9)7-8-15(3,19-14)20-21-16/h7-12,15-18,29,35H,3-6,13-14,19H2,1-2H3;9-14H,5-8H2,1-4H3/b25-15-;/t;9-,10-,11+,12+,13+,14-,15-,16?/m.1/s1 | |||
| StdInChIKey_Ref = {{stdinchicite|correct|chemspider}} | |||
| StdInChIKey = ZVAQGQOEHFIYMQ-NWQBEBBQSA-N | |||
}} | }} | ||
<!-- Definition and medical uses --> | |||
'''Artemether/lumefantrine''', sold under the trade name '''Coartem''' among others, is a combination of the two medications ] and ].<ref name=AHFS2015>{{cite web|title=Artemether and Lumefantrine|url=https://www.drugs.com/monograph/artemether-and-lumefantrine.html|publisher=The American Society of Health-System Pharmacists|access-date=Dec 2, 2015|url-status=live|archive-url=https://web.archive.org/web/20151208162852/http://www.drugs.com/monograph/artemether-and-lumefantrine.html|archive-date=2015-12-08}}</ref> It is used to treat ] caused by '']'' that is not treatable with ].<ref name=AHFS2015/> It is not typically used to prevent malaria.<ref name=AHFS2015/> It is taken by mouth.<ref name=AHFS2015/> | |||
<!-- Side effects and mechanism --> | |||
The combination ''']/]''' (trade names '''Coartem''' and '''Riamet''') is an ]-based combination therapy (ACT) indicated for the treatment of acute uncomplicated ] ] ]. Coartem is produced by the Swiss pharmaceutical company, ]. | |||
Common side effects include muscle and joint pains, fever, loss of appetite, and headache.<ref name=AHFS2015/> Serious side effects include ].<ref name=AHFS2015/> While not well studied, it appears to be safe for use in pregnancy.<ref name=AHFS2015/> The dose does not need changing in those with mild or moderate kidney or liver problems.<ref name=AHFS2015/> | |||
<!-- History, society, and culture --> | |||
⚫ | |||
This combination came into medical use in 1992<ref name=Enr2011>{{cite book|last1=Ravina|first1=Enrique|title=The evolution of drug discovery : from traditional medicines to modern drugs|date=2011|publisher=Wiley-VCH|location=Weinheim|isbn=9783527326693|page=139|edition=1. Aufl.|url=https://books.google.com/books?id=iDNy0XxGqT8C&pg=PA139|url-status=live|archive-url=https://web.archive.org/web/20151208072054/https://books.google.ca/books?id=iDNy0XxGqT8C&pg=PA139|archive-date=2015-12-08}}</ref> and was developed in China.<ref name=Enr2011/><ref>{{cite book|last1=Nightingale|first1=Charles H.|title=Antimicrobial pharmacodynamics in theory and clinical practice|date=2007|publisher=Informa Healthcare|location=New York|isbn=9781420017137|page=380|edition=2nd|url=https://books.google.com/books?id=sXf42EROuhEC&pg=PA380|url-status=live|archive-url=https://web.archive.org/web/20151208050646/https://books.google.ca/books?id=sXf42EROuhEC&pg=PA380|archive-date=2015-12-08}}</ref> It is on the ].<ref name="WHO21st">{{cite book | vauthors = ((World Health Organization)) | title = World Health Organization model list of essential medicines: 21st list 2019 | year = 2019 | hdl = 10665/325771 | author-link = World Health Organization | publisher = World Health Organization | location = Geneva | id = WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO | hdl-access=free }}</ref> It is not available as a ].<ref name=Ric2015>{{cite book|last1=Hamilton|first1=Richart|title=Tarascon Pocket Pharmacopoeia 2015 Deluxe Lab-Coat Edition|date=2015|publisher=Jones & Bartlett Learning|isbn=9781284057560|page=45}}</ref> | |||
==Medical uses== | |||
⚫ | In 2001, |
||
⚫ | The combination is an effective and well-tolerated malaria treatment, providing high cure rates even in areas of multi-drug resistance.<ref>{{cite journal |display-authors=6 |vauthors=Makanga M, Premji Z, Falade C, Karbwang J, Mueller EA, Andriano K, Hunt P, De Palacios PI |title=Efficacy and safety of the six-dose regimen of artemether-lumefantrine in pediatrics with uncomplicated Plasmodium falciparum malaria: a pooled analysis of individual patient data |journal=Am. J. Trop. Med. Hyg. |volume=74 |issue=6 |pages=991–8 |date=June 2006 |pmid=16760509 |doi= 10.4269/ajtmh.2006.74.991|doi-access=free }}</ref><ref>{{cite journal |vauthors=Mueller EA, van Vugt M, Kirch W, Andriano K, Hunt P, de Palacios PI |title=Efficacy and safety of the six-dose regimen of artemether-lumefantrine for treatment of uncomplicated Plasmodium falciparum malaria in adolescents and adults: a pooled analysis of individual patient data from randomized clinical trials |journal=Acta Trop. |volume=100 |issue=1–2 |pages=41–53 |date=November 2006 |pmid=17045558 |doi=10.1016/j.actatropica.2006.09.007 }}</ref> | ||
In 2002, artemether/lumefantrine tablets were added to the WHO's Essential Medicines list,<ref name="File, Coartem Product Monograph 2005"/><ref>Essential Medicines: WHO Model List. 14th Edition. March 2005. Available at: http://whqlibdoc.who.int/hq/2005/a87017_eng.pdf. Accessed November 8, 2005 (from Coartem Fact-Sheet)</ref> an index of essential drugs which help guide the purchasing decisions of Member States and UN agencies. | |||
Coartem is approved in over 80 countries worldwide, including various countries in Africa, as well as ], the ] (EMA) and the ] (FDA). | |||
Since 2001, Novartis has supplied 250 million treatments of Coartem without profit for public sector use in Africa, saving an estimated 630,000 lives.{{citation needed|date=January 2011}} | |||
==Side effects== | ==Side effects== | ||
Coartem can cause ]s. The drug frequently causes headache, dizziness and ], although mild forms in most cases. Other fairly common side effects (more than 3% of patients) include sleep disorder, ], ], ], as well as unspecific reactions like ], |
Coartem can cause ]s. The drug frequently causes headache, dizziness and ], although mild forms in most cases. Other fairly common side effects (more than 3% of patients) include sleep disorder, ], ], ], as well as unspecific reactions like ], gastrointestinal disorders, itch and ].<ref name="Drugs.com"> {{webarchive |url=https://web.archive.org/web/20160521122932/http://www.drugs.com/coartem.html |date=May 21, 2016 }}</ref> | ||
==Interactions== | ==Interactions== | ||
Coartem has a potential to ], so combinations with other drugs having that property can cause |
Food, in particular fat, enhances the absorption of both artemether and lumefantrine, and patients are advised to take the tablets with food as soon as a meal can be tolerated. Coartem has a potential to ], so combinations with other drugs having that property can cause irregular heartbeat, potentially leading to lethal ]. The combination with ], another antimalarial, can cause a life-threatening QT prolongation. Drugs and other substances influencing the activity of the liver enzyme ], including grapefruit juice, can either increase or lower blood levels of artemether/lumefantrine, depending on the sort of substance. This can either lead to more severe side effects or to reduced efficiency.<ref name="Drugs.com" /> | ||
==History== | |||
Drugs and other substances influencing the activity of the liver enzyme ], including ], can either increase or lower blood levels of artemether/lumefantrine, depending on the sort of substance. This can either lead to more severe side effects or to reduced efficiency.<ref name="Drugs.com" /> | |||
⚫ | In 2001, the first fixed dose ]-based combination therapy to meet the World Health Organization's (WHO) pre-qualification criteria for efficacy, safety and quality was created.<ref>WHO Prequalification Programme: Priority Essential Medicines. Access to Artemesinin-based antimalarial medicinal products of acceptable quality. Available at http://healthtech.whoz.int/pq/lists/{{dead link|date=October 2016 |bot=InternetArchiveBot |fix-attempted=yes }} mal_suppliers.pdf Accessed May 2008.</ref><ref>WHO Health Systems and Services: Prequalification Programme. Available at {{cite web|url=http://healthtech.who.int/pq/ |title=New Page 1 |access-date=2009-05-20 |url-status=dead |archive-url=https://web.archive.org/web/20090513060741/http://healthtech.who.int/pq/ |archive-date=2009-05-13 }} Accessed May 2008.</ref> It is approved in over 80 countries worldwide, including various countries in Africa, as well as ], the ] (EMA) and the ] (FDA). | ||
== |
==Society and culture== | ||
===Access to treatment=== | |||
Coartem is provided without profit to developing countries using grants from the ], US President’s Malaria Initiative along with other donors. | |||
⚫ | Coartem is provided without profit to developing countries using grants from the ], US ] along with other donors. Novartis has lowered the price of Coartem by 50% since 2001, increasing access to patients around the world. The first significant price reduction occurred in 2006, when the price of Coartem decreased from an average of US$1.57 to US$1.00. In 2006, due to an improved supply situation for the natural ingredient artemisinin, Novartis was able to undertake the pharmaceutical industry's most aggressive manufacturing scale-up of its kind from 4 million treatments in 2004 to 62 million treatments in 2006.{{citation needed|date=March 2016}} Novartis and its partners invested heavily in expanding production capacity at their facilities in China, and Suffern, New York. This increase in production capacity ensured that supplies of Coartem met demand which enabled Novartis to further decrease the price of Coartem. In April 2008, Novartis further reduced the public sector price of Coartem by approximately 20%, to an average of US$0.80 (or US$0.37 for a child's treatment pack). This price reduction was made possible through production efficiency gains. | ||
⚫ | Prior to this program, Novartis was criticised for ] against India, seeking to prohibit the marketing of cheap generic drugs. An Indian court ruled against Novartis, saying that the case was a "threat to people suffering from cancer and other diseases who are too poor to pay for them".<ref> {{webarchive |url=https://web.archive.org/web/20110515184029/http://www.maketradefair.com/en/index.php?file=a2m_main.html |date=May 15, 2011 }}</ref> | ||
⚫ | Novartis has lowered the price of Coartem by 50% since 2001, increasing access to patients around the world. The first significant price reduction occurred in 2006, when the price of Coartem decreased from an average of US |
||
⚫ | ===Approval in the United States=== | ||
In April 2008, Novartis further reduced the public sector price of Coartem by approximately 20%, to an average of US $0.80 (or US $0.37 for a child’s treatment pack). This price reduction was made possible through production efficiency gains. | |||
On April 8, 2009, the U.S. Food and Drug Administration (FDA) announced that Coartem was approved for the treatment of acute, uncomplicated malaria infections in adults and children weighing at least five kilograms (approximately 11 pounds)<ref>{{cite web |url=http://www.fda.gov/bbs/topics/NEWS/2009/NEW01989.html |title=FDA Approves Coartem Tablets to Treat Malaria |website=www.fda.gov |access-date=14 January 2022 |archive-url=https://web.archive.org/web/20090411103034/http://www.fda.gov/bbs/topics/NEWS/2009/NEW01989.html |archive-date=11 April 2009 |url-status=dead}}</ref> becoming the first artemisinin-based combination therapy approved in the United States. | |||
⚫ | ===Dispersible=== | ||
⚫ | Prior to this program, Novartis was criticised for ] against |
||
In January 2009, Novartis and ] (MMV) launched Coartem Dispersible, an ]-based combination therapy developed specifically for children with malaria. Coartem Dispersible contains the same ratio of artemether and lumefantrine as Coartem. It works as well as other formulations.<ref>{{cite journal |vauthors=Abdulla S, Sagara I, Borrmann S, D'Alessandro U, González R, Hamel M, Ogutu B, Mårtensson A, Lyimo J, Maiga H, Sasi P, Nahum A, Bassat Q, Juma E, Otieno L, Björkman A, Beck HP, Andriano K, Cousin M, Lefèvre G, Ubben D, Premji Z |display-authors=6 |title=Efficacy and safety of artemether-lumefantrine dispersible tablets compared with crushed commercial tablets in African infants and children with uncomplicated malaria: a randomised, single-blind, multicentre trial |journal=Lancet |volume=372 |issue=9652 |pages=1819–27 |date=November 2008 |pmid=18926569 |doi=10.1016/S0140-6736(08)61492-0 |s2cid=8207921 }}</ref> The sweet-tasting Coartem Dispersible tablets disperse quickly in small amounts of water, easing administration and ensuring effective dosing. | |||
⚫ | == |
||
In January 2009, Novartis and ] (MMV) launched Coartem Dispersible, the first ]-based combination therapy developed specifically for children suffering from malaria. Coartem Dispersible contains the same amount of artemether and lumefantrine as Coartem. A phase III study published in The Lancet showed that Coartem Dispersible provides a high cure rate of 97.8% for uncomplicated '']'' malaria, which is comparable to that of Coartem (98.5%). Investigators also reported that it had a good safety profile.<ref>{{pmid|18926569}}</ref> | |||
The sweet-tasting Coartem Dispersible tablets disperse quickly in small amounts of water, easing administration and ensuring effective dosing. | |||
Novartis and MMV provide malaria case management educational programs, which include hands-on training for local healthcare workers, customized training manuals, and user-friendly packaging to ensure that Coartem Dispersible is properly used and to improve patient compliance. Like Coartem, Coartem Dispersible is provided to the public sector without profit.{{citation needed|date=March 2011}} | |||
⚫ | ==Approval in the United States== | ||
On April 8, 2009, the U.S. Food and Drug Administration (FDA) announced that Coartem was approved for the treatment of acute, uncomplicated malaria infections in adults and children weighing at least five kilograms (approximately 11 pounds)<ref>http://www.fda.gov/bbs/topics/NEWS/2009/NEW01989.html</ref> becoming the first ACT approved in the United States. Millions of Americans travel to malaria-endemic regions on business or pleasure, and cases of travelers’ malaria continue to be a problem. In addition, many of the ] are stationed in malaria-endemic countries. US patients now have access to ACTs, the standard of care and treatment for malaria. | |||
Coartem is now available in the United States through major wholesalers. This distribution model will allow patients in need to have access to the drug within 24 hours through retail pharmacies across the country. Novartis will sell the entire 24-tablet adult course of Coartem therapy for $69.60, on par with other currently available branded antimalarial treatments. The amount one pays at the pharmacy will depend upon insurance coverage and what the pharmacy charges for the medication. | |||
Coartem was granted priority review by the FDA, a treatment typically granted to address urgent, unmet medical needs. Along with FDA approval, Novartis was awarded a one-time priority review voucher to be used for a future new drug application. | |||
Artemether/lumefantrine tablets are available in Pakistan under trade name '''Artelum''' by W. Woodwards Pakistan. | |||
==References== | ==References== | ||
{{ |
{{reflist}} | ||
{{Antimalarials}} | {{Antimalarials}} | ||
{{Portal bar|Medicine}} | |||
⚫ | {{DEFAULTSORT:Artemether |
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⚫ | {{DEFAULTSORT:Artemether Lumefantrine}} | ||
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Latest revision as of 01:18, 21 April 2024
Combination drug Pharmaceutical compoundCombination of | |
---|---|
Artemether | Antimalarial |
Lumefantrine | Antimalarial |
Clinical data | |
Trade names | Coartem, Riamet, Falcynate-LF |
AHFS/Drugs.com | Monograph |
MedlinePlus | a609024 |
Pregnancy category |
|
Routes of administration | By mouth |
ATC code | |
Legal status | |
Legal status | |
Identifiers | |
CAS Number | |
ChemSpider | |
(what is this?) (verify) |
Artemether/lumefantrine, sold under the trade name Coartem among others, is a combination of the two medications artemether and lumefantrine. It is used to treat malaria caused by Plasmodium falciparum that is not treatable with chloroquine. It is not typically used to prevent malaria. It is taken by mouth.
Common side effects include muscle and joint pains, fever, loss of appetite, and headache. Serious side effects include prolongation of the QT interval. While not well studied, it appears to be safe for use in pregnancy. The dose does not need changing in those with mild or moderate kidney or liver problems.
This combination came into medical use in 1992 and was developed in China. It is on the World Health Organization's List of Essential Medicines. It is not available as a generic medication.
Medical uses
The combination is an effective and well-tolerated malaria treatment, providing high cure rates even in areas of multi-drug resistance.
Side effects
Coartem can cause anaphylactic reactions. The drug frequently causes headache, dizziness and anorexia, although mild forms in most cases. Other fairly common side effects (more than 3% of patients) include sleep disorder, tinnitus, tremor, palpitation, as well as unspecific reactions like vertigo, gastrointestinal disorders, itch and nasopharyngitis.
Interactions
Food, in particular fat, enhances the absorption of both artemether and lumefantrine, and patients are advised to take the tablets with food as soon as a meal can be tolerated. Coartem has a potential to prolong the QT interval, so combinations with other drugs having that property can cause irregular heartbeat, potentially leading to lethal ventricular fibrillation. The combination with halofantrine, another antimalarial, can cause a life-threatening QT prolongation. Drugs and other substances influencing the activity of the liver enzyme CYP3A4, including grapefruit juice, can either increase or lower blood levels of artemether/lumefantrine, depending on the sort of substance. This can either lead to more severe side effects or to reduced efficiency.
History
In 2001, the first fixed dose artemisinin-based combination therapy to meet the World Health Organization's (WHO) pre-qualification criteria for efficacy, safety and quality was created. It is approved in over 80 countries worldwide, including various countries in Africa, as well as Swissmedic, the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).
Society and culture
Access to treatment
Coartem is provided without profit to developing countries using grants from the Global Fund to Fight AIDS, Tuberculosis and Malaria, US President's Malaria Initiative along with other donors. Novartis has lowered the price of Coartem by 50% since 2001, increasing access to patients around the world. The first significant price reduction occurred in 2006, when the price of Coartem decreased from an average of US$1.57 to US$1.00. In 2006, due to an improved supply situation for the natural ingredient artemisinin, Novartis was able to undertake the pharmaceutical industry's most aggressive manufacturing scale-up of its kind from 4 million treatments in 2004 to 62 million treatments in 2006. Novartis and its partners invested heavily in expanding production capacity at their facilities in China, and Suffern, New York. This increase in production capacity ensured that supplies of Coartem met demand which enabled Novartis to further decrease the price of Coartem. In April 2008, Novartis further reduced the public sector price of Coartem by approximately 20%, to an average of US$0.80 (or US$0.37 for a child's treatment pack). This price reduction was made possible through production efficiency gains.
Prior to this program, Novartis was criticised for a court case they launched against India, seeking to prohibit the marketing of cheap generic drugs. An Indian court ruled against Novartis, saying that the case was a "threat to people suffering from cancer and other diseases who are too poor to pay for them".
Approval in the United States
On April 8, 2009, the U.S. Food and Drug Administration (FDA) announced that Coartem was approved for the treatment of acute, uncomplicated malaria infections in adults and children weighing at least five kilograms (approximately 11 pounds) becoming the first artemisinin-based combination therapy approved in the United States.
Dispersible
In January 2009, Novartis and Medicines for Malaria Venture (MMV) launched Coartem Dispersible, an artemisinin-based combination therapy developed specifically for children with malaria. Coartem Dispersible contains the same ratio of artemether and lumefantrine as Coartem. It works as well as other formulations. The sweet-tasting Coartem Dispersible tablets disperse quickly in small amounts of water, easing administration and ensuring effective dosing.
References
- ^ "Artemether and Lumefantrine". The American Society of Health-System Pharmacists. Archived from the original on 2015-12-08. Retrieved Dec 2, 2015.
- ^ Ravina, Enrique (2011). The evolution of drug discovery : from traditional medicines to modern drugs (1. Aufl. ed.). Weinheim: Wiley-VCH. p. 139. ISBN 9783527326693. Archived from the original on 2015-12-08.
- Nightingale, Charles H. (2007). Antimicrobial pharmacodynamics in theory and clinical practice (2nd ed.). New York: Informa Healthcare. p. 380. ISBN 9781420017137. Archived from the original on 2015-12-08.
- World Health Organization (2019). World Health Organization model list of essential medicines: 21st list 2019. Geneva: World Health Organization. hdl:10665/325771. WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO.
- Hamilton, Richart (2015). Tarascon Pocket Pharmacopoeia 2015 Deluxe Lab-Coat Edition. Jones & Bartlett Learning. p. 45. ISBN 9781284057560.
- Makanga M, Premji Z, Falade C, Karbwang J, Mueller EA, Andriano K, et al. (June 2006). "Efficacy and safety of the six-dose regimen of artemether-lumefantrine in pediatrics with uncomplicated Plasmodium falciparum malaria: a pooled analysis of individual patient data". Am. J. Trop. Med. Hyg. 74 (6): 991–8. doi:10.4269/ajtmh.2006.74.991. PMID 16760509.
- Mueller EA, van Vugt M, Kirch W, Andriano K, Hunt P, de Palacios PI (November 2006). "Efficacy and safety of the six-dose regimen of artemether-lumefantrine for treatment of uncomplicated Plasmodium falciparum malaria in adolescents and adults: a pooled analysis of individual patient data from randomized clinical trials". Acta Trop. 100 (1–2): 41–53. doi:10.1016/j.actatropica.2006.09.007. PMID 17045558.
- ^ Drugs.com: Coartem Archived May 21, 2016, at the Wayback Machine
- WHO Prequalification Programme: Priority Essential Medicines. Access to Artemesinin-based antimalarial medicinal products of acceptable quality. Available at http://healthtech.whoz.int/pq/lists/ mal_suppliers.pdf Accessed May 2008.
- WHO Health Systems and Services: Prequalification Programme. Available at "New Page 1". Archived from the original on 2009-05-13. Retrieved 2009-05-20. Accessed May 2008.
- Make Trade Fair: Patients before Profits. Archived May 15, 2011, at the Wayback Machine
- "FDA Approves Coartem Tablets to Treat Malaria". www.fda.gov. Archived from the original on 11 April 2009. Retrieved 14 January 2022.
- Abdulla S, Sagara I, Borrmann S, D'Alessandro U, González R, Hamel M, et al. (November 2008). "Efficacy and safety of artemether-lumefantrine dispersible tablets compared with crushed commercial tablets in African infants and children with uncomplicated malaria: a randomised, single-blind, multicentre trial". Lancet. 372 (9652): 1819–27. doi:10.1016/S0140-6736(08)61492-0. PMID 18926569. S2CID 8207921.
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