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WHO Public Assessment Reports (WHOPARs) Medicines

Each WHO Public Assessment Report is listed by WHO reference number and therapeutic area. Each listing also provides the relevant International Nonproprietary Name (INN), the dosage formulation and dosage strength, and the name of the supplier.

The summary of product characteristics/patient information leaflet included in these WHOPARs focus on uses of the medicines covered by WHO Prequalification Team - Medicines. The recommendations for use are based on WHO guidelines and on information from stringent regulatory authorities (term to be revised). The medicine may be authorised for additional or different uses by national medicines regulatory authorities.

Refer to the Contents and structure of a WHOPAR section for information about the value of WHOPARS and the information they contain.

M
BT-CV001
Tocilizumab
20mg/mL (Each vial contains 80mg of tocilizumab in 4mL) - Concentrate for solution for infusion
Roche Registration GmbH
Germany
M
BT-CV002
Tocilizumab
20mg/mL (Each vial contains 200mg of tocilizumab in 10mL) - Concentrate for solution for infusion
Roche Registration GmbH
Germany
M
BT-CV003
Tocilizumab
20mg/ml (Each vial contains 400mg of tocilizumab in 20mL) - Concentrate for solution for infusion
Roche Registration GmbH
Germany
M
BT-DM001
Insulin Human
100 IU/mL - Solution for injection
Novo Nordisk AS
Denmark
M
BT-DM002
Insulin Human
100 IU/mL - Solution for injection
Novo Nordisk AS
Denmark
M
BT-DM003
Insulin Human
100 IU/mL - Suspension for injection
Novo Nordisk AS
Denmark
M
BT-DM004
Insulin Human
100 IU/mL - Suspension for injection
Novo Nordisk AS
Denmark
M
BT-DM005
Insulin Glargine
100 U/mL - Solution for injection
Sanofi-Aventis Deutschland GmbH
Germany
M
BT-DM006
Insulin Glargine
100 U/mL - Solution for injection
Sanofi-Aventis Deutschland GmbH
Germany
M
BT-EB001
Atoltivimab/Maftivimab/Odesivimab
16.67 mg/mL/16.67 mg/mL/16.67 mg/mL - Solution for infusion
Regeneron Pharmaceuticals Inc.
United States of America
M
BT-EB002
Atoltivimab/Maftivimab/Odesivimab
33.33mg/mL/33.33mg/mL/33.33mg/mL - Solution for infusion
Regeneron Pharmaceuticals Inc.
United States of America
M
BT-ON001
Trastuzumab
150mg - Powder for concentrate for solution for infusion
Samsung Bioepis NL B.V
Netherlands (Kingdom of the)
M
BT-ON002
Trastuzumab
150mg - Powder for concentrate for solution for infusion
Celltrion Inc
Republic of Korea
M
BT-ON003
Trastuzumab
420mg - Powder for concentrate for solution for infusion
Celltrion Inc
Republic of Korea
M
BT-ON004
Rituximab
100mg - Concentrate for solution for infusion
Celltrion Inc
Republic of Korea
M
BT-ON005
Rituximab
500mg - Concentrate for solution for infusion
Celltrion Inc
Republic of Korea
M
BT-ON006
Rituximab
100mg - Concentrate for solution for infusion
Sandoz GmbH
Austria
M
BT-ON007
Rituximab
500mg - Concentrate for solution for infusion
Sandoz GmbH
Austria
M
BT-ON008
Trastuzumab
150mg - Powder for concentrate for solution for infusion
Mylan Pharmaceuticals Pvt Ltd
India
M
BT-ON009
Trastuzumab
150mg - Powder for concentrate for solution for infusion
Roche Products Ltd
United Kingdom of Great Britain and Northern Ireland
M
BT-ON010
Trastuzumab + Water for Injection
440mg + 1.1% benzyl alcohol - Powder for concentrate for solution for infusion
Roche Products Ltd
United Kingdom of Great Britain and Northern Ireland
M
BT-ON011
Rituximab
100mg/10mL - Concentrate for solution for infusion
Roche Products Ltd
United Kingdom of Great Britain and Northern Ireland
M
BT-ON012
Rituximab
500mg/50mL - Concentrate for solution for infusion
Roche Products Ltd
United Kingdom of Great Britain and Northern Ireland
M
BT-ON013
Trastuzumab
150mg - Powder for concentrate for solution for infusion
Biocon Biologics Limited
United Kingdom of Great Britain and Northern Ireland
M
BT-ON014
Trastuzumab + Water for Injection
420mg + 20ml - Powder for concentrate for solution for infusion
Biocon Biologics Limited
United Kingdom of Great Britain and Northern Ireland
M
BT-ON016
Trastuzumab
420mg - Powder for concentrate for solution for infusion
Mylan Pharmaceuticals Private Limited
India
M
BT-ON017
Benzyl alcohol/Water for Injection + Trastuzumab
1.1%/20mL + 440mg - Powder for concentrate for solution for infusion
Mylan Pharmaceuticals Private Limited
India
M
CV004
Dexamethasone (sodium phosphate)
4mg/ml - Solution for injection
Farmak JSC
Ukraine
M
CV005
Dexamethasone (sodium phosphate)
3.3mg/ml (1ml) - Solution for injection
Noridem Enterprises Ltd
Cyprus
M
CV006
Dexamethasone (sodium phosphate)
4mg/ml (2ml) - Solution for injection
Demo SA
Greece
M
CV007
Nirmatrelvir + Ritonavir
150mg + 100mg - Film-coated tablet
Pfizer Limited
United Kingdom of Great Britain and Northern Ireland
M
CV008
Molnupiravir
200mg - Hard capsules
Hetero Labs Ltd
India
M
CV009
Molnupiravir
200mg - Hard capsules
Dr Reddy's Laboratories Limited
India
M
CV010
Molnupiravir
200mg - Capsules, hard
Emcure Pharmaceuticals Ltd
India
M
CV011
Remdesivir
100mg - Powder for concentrate for solution for infusion
Gilead Sciences Ireland UC
Ireland
M
CV012
Nirmatrelvir + Ritonavir
150mg + 100mg - Tablet, Film-coated
Hetero Labs Ltd
India
M
CV014
Molnupiravir
200mg - Capsules, hard
Aurobindo Pharma Ltd
India
M
CV016
Nirmatrelvir + Ritonavir
150mg + 100mg - Tablet, Film-coated + Tablet, Film-coated
Zhejiang Huahai Pharmaceutical Co. Ltd
China
M
CV017
Nirmatrelvir + Ritonavir
150mg + 100mg - Tablet, Film-coated + Tablet, Film-coated
Celltrion Inc.
Republic of Korea
M
CV018
Nirmatrelvir + Ritonavir
150mg + 100mg - Tablet, Film-coated + Tablet, Film-coated
Zhejiang Apeloa Kangyu Pharmaceutical Co. Ltd
China
M
CV019
Molnupiravir
200mg - Capsules, hard
Shanghai Desano Bio-Pharmaceutical Co. Ltd
China
M
CV020
Nirmatrelvir + Ritonavir
150mg + 100mg - Tablet, Film-coated + Tablet, Film-coated
Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd
China
M
CV021
Molnupiravir
200mg - Capsules, hard
Cipla Ltd
India
M
CV022
Molnupiravir
200mg - Capsules, hard
Mylan Laboratories Limited
India
M
CV023
Molnupiravir
200mg - Capsules, hard
Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd
China
M
DI002
Zinc (as sulfate monohydrate)
20mg - Dispersible tablets
Laboratoires Pharmaceutiques Rodael
France
M
DI005
Zinc sulfate
20mg - Dispersible tablet
Macleods Pharmaceuticals Ltd
India
M
DI009
Zinc (sulfate)
20mg - Tablet, Dispersible
PharmEvo (Pvt) Ltd
Pakistan
M
DI010
Zinc (sulfate)
10mg/5ml - Syrup
PharmEvo (Pvt) Ltd
Pakistan
M
DI011
Zinc (sulfate)
20mg - Dispersible tablet
Ipca Laboratories Ltd
India
M
DI013
Zinc (sulfate)
20mg - Dispersible Tablet
The ACME Laboratories Ltd
Bangladesh
M
DI014
Zinc (sulfate)
20mg - Tablet, Dispersible
Swiss Pharma Nigeria Ltd
Nigeria
M
HA060
Lamivudine/Zidovudine
150mg/300mg - Film-coated tablets
Cipla Ltd
India
M
HA096
Ritonavir
80mg/mL - Oral solution
Abbott Laboratories Ltd
United Kingdom of Great Britain and Northern Ireland
M
HA098
Lopinavir/Ritonavir
80mg/mL/20mg/mL - Oral solution
AbbVie Ltd
United Kingdom of Great Britain and Northern Ireland
M
HA106
Abacavir (sulfate)
300mg - Film-coated tablet
ViiV Healthcare
United Kingdom of Great Britain and Northern Ireland
M
HA107
Abacavir (sulfate)
20mg/mL - Oral solution
ViiV Healthcare
United Kingdom of Great Britain and Northern Ireland
M
HA108
Zidovudine
100mg - Hard capsules
ViiV Healthcare
United Kingdom of Great Britain and Northern Ireland
M
HA109
Zidovudine
250mg - Hard capsules
ViiV Healthcare UK Limited
United Kingdom of Great Britain and Northern Ireland
M
HA110
Lamivudine/Zidovudine
150mg/300mg - Film-coated tablets
ViiV Healthcare
United Kingdom of Great Britain and Northern Ireland
M
HA114
Zidovudine
10mg/mL - Solution for injection
ViiV Healthcare
United Kingdom of Great Britain and Northern Ireland
M
HA115
Zidovudine
50mg/5mL - Oral solution
ViiV Healthcare UK Limited
United Kingdom of Great Britain and Northern Ireland
M
HA117
Lamivudine
150mg - Film-coated tablet
ViiV Healthcare
United Kingdom of Great Britain and Northern Ireland
M
HA128
Lamivudine
10mg/mL - Oral solution
ViiV Healthcare UK Limited
United Kingdom of Great Britain and Northern Ireland
M
HA200
Nevirapine
50mg/5ml - Oral suspension
Cipla Ltd
India
M
HA286
Lamivudine/Zidovudine
150mg/300mg Tablets
Sun Pharmaceutical Industries Limited
India
M
HA291
Lamivudine/Zidovudine
150mg/300mg Tablets
Strides Pharma Science Limited
India
M
HA306
Efavirenz
600mg Tablets
Sun Pharmaceutical Industries Limited
India
M
HA338
Efavirenz
30mg/ml Oral solution
Merck Sharp & Dohme
Netherlands (Kingdom of the)
M
HA352
Efavirenz
600mg - Tablets
Cipla Ltd
India
M
HA353
Lamivudine
150mg - Tablets
Cipla Ltd
India
M
HA354
Lamivudine
300mg - Film-coated tablets
Cipla Ltd
India
M
HA371
Abacavir (as sulfate)
300mg Film-coated tablets
Cipla Ltd
India
M
HA381
Lopinavir/Ritonavir
200mg/50mg Film-coated tablets
AbbVie Deutschland GmbH Co. KG
Germany
M
HA389
Efavirenz
200mg - Tablets
Strides Pharma Science Ltd
India
M
HA390
Efavirenz
600mg - Tablets
Strides Pharma Science Ltd
India
M
HA392
Lamivudine/Zidovudine
150mg/300mg Tablets
Mylan Laboratories Ltd
India
M
HA403
Efavirenz
600mg - Tablets
Mylan Laboratories Ltd
India
M
HA410
Tenofovir Disoproxil Fumarate
300mg - Tablets
Mylan Laboratories Ltd
India
M
HA414
Lamivudine/Tenofovir disoproxil fumarate
300mg/300mg - Tablets
Mylan Laboratories Ltd
India
M
HA417
Emtricitabine/Tenofovir disoproxil fumarate
200mg/300mg - Tablets
Mylan Laboratories Ltd
India
M
HA421
Atazanavir
150mg Capsules
Bristol-Myers Squibb
United States of America
M
HA424
Lamivudine
150mg - Tablets
Macleods Pharmaceuticals Ltd
India
M
HA426
Lamivudine/Nevirapine/Zidovudine
150mg/200mg/300mg - Tablets
Mylan Laboratories Ltd
India
M
HA433
Lamivudine/Nevirapine/Zidovudine
30mg/50mg/60mg - Dispersible tablets
Mylan Laboratories Ltd
India
M
HA439
Emtricitabine/Tenofovir disoproxil fumarate
200mg/300mg - Tablets
Cipla Ltd
India
M
HA444
Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate
600mg/200mg/300mg - Tablets
Mylan Laboratories Ltd
India
M
HA448
Lamivudine/Tenofovir disoproxil fumarate
300mg/300mg - Tablets
Hetero Labs Limited
India
M
HA459
Lamivudine/Zidovudine
150mg/300mg - Tablets
Macleods Pharmaceuticals Ltd
India
M
HA466
Efavirenz/Lamivudine/Tenofovir disoproxil fumarate
600mg/300mg/300mg - Tablets
Mylan Laboratories Ltd
India
M
HA467
Ritonavir
100mg - Tablets
Mylan Laboratories Ltd
India
M
HA479
Ceftriaxone (as sodium)
1g - Powder for injection
Egyptian International Pharmaceutical Industries Co (EIPICO)
Egypt
M
HA480
Ceftriaxone (as sodium)
0.5g - Powder for injection
Egyptian International Pharmaceutical Industries Co (EIPICO)
Egypt
M
HA483
Zidovudine
300mg - Film-coated tablets
Micro Labs Ltd
India
M
HA485
Lamivudine/Zidovudine
150mg/300mg - Tablets
Micro Labs Ltd
India
M
HA486
Zidovudine
50mg/5ml - Oral solution
Hetero Labs Ltd
India
M
HA490
Lamivudine/Zidovudine
150mg/300mg - Tablets
Universal Corporation Ltd
Kenya
M
HA491
Ritonavir
100mg - Film-coated tablet
AbbVie LTD Deutschland GmbH and Com KG
Germany
M
HA492
Lopinavir/Ritonavir
200mg/50mg - Film-coated tablet
Hetero Labs Ltd
India
M
HA494
Abacavir (as sulfate)
300mg - Tablets
Strides Shasun Ltd
India
M
HA498
Emtricitabine/Tenofovir disoproxil (fumarate)
200mg/300mg - Film-coated tablets
Hetero Labs Ltd
India
M
HA500
Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate
600mg/200mg/300mg - Tablets
Cipla Ltd
India
M
HA510
Nevirapine
50mg - Dispersible tablets
Cipla Ltd
India
M
HA514
Lamivudine/Tenofovir disoproxil fumarate
300mg/300mg - Tablets
Macleods Pharmaceuticals Ltd
India
M
HA515
Ganciclovir (sodium)
500mg - Powder for solution for injection
Hainan Poly Pharm Co. Ltd
China
M
HA516
Tenofovir disoproxil fumarate
300mg - Tablets
Macleods Pharmaceuticals Ltd
India
M
HA518
Abacavir (as sulfate)/Lamivudine
60mg/30mg - Dispersible tablets
Cipla Ltd
India
M
HA521
Lamivudine/Zdovudine
Tablets - 150mg/300mg
Hetero Labs Limited
India
M
HA523
Lamivudine
10mg/ml - Oral solution
Macleods Pharmaceuticals Ltd
India
M
HA524
Lamivudine/Nevirapine/Zidovudine
150mg/200mg/300mg - Tablets
Strides Shasun Ltd
India
M
HA525
Lamivudine/Tenofovir disoproxil fumarate
300mg/300mg - Tablets
Sun Pharmaceutical Industries Limited
India
M
HA526
Zidovudine
50mg/5ml - Oral solution
Macleods Pharmaceuticals Ltd
India
M
HA529
Darunavir (as ethanolate)
75mg - Tablets
Janssen-Cilag International NV
Belgium
M
HA530
Darunavir (as ethanolate)
150mg - Tablets
Janssen-Cilag International NV
Belgium
M
HA532
Etravirine
100mg - Tablets
Janssen-Cilag International NV
Belgium
M
HA535
Tenofovir disoproxil fumarate
300mg - Tablets
Strides Shasun Ltd
India
M
HA538
Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate
600mg/200mg/300mg - Film-coated tablets
Hetero Labs Ltd
India
M
HA549
Efavirenz/Lamivudine/Tenofovir disoproxil fumarate
600mg/300mg/300mg - Film-coated tablet
Hetero Labs Ltd
India
M
HA551
Emtricitabine/Tenofovir disoproxil (fumarate)
200mg/300mg - Film-coated tablets
Sun Pharmaceutical Industries Limited
India
M
HA552
Emtricitabine/Tenofovir disoproxil fumarate
200mg/300mg - Tablets
Strides Pharma Science Limited
India
M
HA553
Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate
600mg/200mg/300mg - Film-coated tablets
Strides Shasun Ltd
India
M
HA555
Lamivudine/Zidovudine
30mg/60mg - Tablets
Micro Labs Ltd
India
M
HA557
Lamivudine/Nevirapine/Zidovudine
30mg/50mg/60mg - Dispersible tablets
Strides Pharma Science Limited
India
M
HA561
Emtricitabine/Tenofovir disoproxil (fumarate)
200mg/300mg - Film-coated tablets
Macleods Pharmaceuticals Ltd
India
M
HA562
Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate
600mg/200mg/300mg - Film-coated tablets
Macleods Pharmaceuticals Ltd
India
M
HA565
Ritonavir
100mg - Tablet, Film-coated
Hetero Labs Ltd
India
M
HA570
Nevirapine
200mg - Tablets
Micro Labs Limited
India
M
HA572
Lamivudine/Zidovudine
30mg/60mg - Dispersible tablets
Mylan Laboratories Ltd
India
M
HA573
Lopinavir/Ritonavir
100mg/25mg - Tablets
Macleods Pharmaceuticals Ltd
India
M
HA574
Lopinavir/Ritonavir
200mg/50mg - Tablets
Macleods Pharmaceuticals Ltd
India
M
HA593
Efavirenz/Lamivudine/Tenofovir disoproxil fumarate
600mg/300mg/300mg - Tablets
Cipla Ltd
India
M
HA597
Ondansetron (as hydrochloride dihydrate)
4mg/2ml - Solution for injection
DEMO SA
Greece
M
HA598
Sulfamethoxazole/Trimethoprim
400mg/80mg - Tablets
Micro Labs Ltd
India
M
HA599
Sulfamethoxazole/Trimethoprim
800mg/160mg - Tablets
Micro Labs Ltd
India
M
HA600
Etravirine
25mg - Tablets
Janssen-Cilag International NV
Belgium
M
HA602
Aciclovir
250mg - Lyophilisate for solution for injection
DEMO SA
Greece
M
HA607
Ondansetron (hydrochloride)
8mg/4ml - Solution for injection
DEMO SA
Greece
M
HA611
Efavirenz/Lamivudine/Tenofovir disoproxil fumarate
600mg/300mg/300mg - Tablets
Macleods Pharmaceuticals Ltd
India
M
HA618
Dexamethasone phosphate (as sodium salt)
4mg/ml - Solution for injection
Kern Pharma S. L.
Spain
M
HA620
Lamivudine/Tenofovir disoproxil fumarate
300mg/300mg - Tablets
Micro Labs Limited
India
M
HA621
Ritonavir
25mg - Tablets
Mylan Laboratories Ltd
India
M
HA622
Ceftriaxone (sodium)
1g - Powder for solution for injection
Sinopharm Zhijun Pharmaceutical Co Ltd
China
M
HA627
Darunavir
400mg - Film-coated tablets
Cipla Ltd
India
M
HA628
Darunavir
600mg - Film-coated tablets
Cipla Ltd
India
M
HA629
Lamivudine/Nevirapine/Zidovudine
150mg/200mg/300mg - Film-coated tablet
Micro Labs Ltd
India
M
HA631
Emtricitabine/Tenofovir disoproxil fumarate
200mg/300mg - Film-coated tablets
Micro Labs Ltd
India
M
HA632
Atazanavir (sulfate)/Ritonavir
300mg/100mg - Film-coated tablet
Cipla Ltd
India
M
HA633
Efavirenz
600mg - Film-coated tablet
Micro Labs Ltd
India
M
HA634
Dolutegravir (as sodium salt)
50mg - Film-coated tablets
ViiV Healthcare BV
Netherlands (Kingdom of the)
M
HA635
Abacavir (sulfate)/Lamivudine
600mg/300mg - Film-coated tablets
Mylan Laboratories Ltd
India
M
HA636
Morphine hydrochloride
10mg - Prolonged-release tablets
G.L. Pharma GmbH
Austria
M
HA637
Morphine hydrochloride
30mg - Prolonged-release tablets
G.L. Pharma GmbH
Austria