WHO Drug Information Vol. 17, No. 3, 2003
(2003; 85 pages) Ver el documento en el formato PDF
Índice de contenido
Abrir esta carpeta y ver su contenidoRational Use of Drugs
Abrir esta carpeta y ver su contenidoSafety and Efficacy Issues
Abrir esta carpeta y ver su contenidoIndividual Drugs
Cerrar esta carpetaAspects of Quality Assurance
Ver el documentoPre-qualification of HIV drugs
Ver el documentoAccess to generic antiretrovirals
Ver el documentoList of pre-qualified products: 20 August 2003
Abrir esta carpeta y ver su contenidoConsultation Document
Abrir esta carpeta y ver su contenidoRegulatory and Safety Action
Abrir esta carpeta y ver su contenidoRegulatory Challenges
Abrir esta carpeta y ver su contenidoATC/DDD Classification
Ver el documentoProposed International Nonproprietary Names: List 89
Ver el documentoAnnex 1 - Procedure for the selection of recommended international nonproprietary names for pharmaceutical substances*
Ver el documentoAnnex 2 - General principles for guidance in devising international nonproprietary names for pharmaceutical substances*
Ver el documentoAnnexe 1 - Procédure a suivre en vue du choix de dénominations communes internationales recommandées pour les substances pharmaceutiques
Ver el documentoAnnexe 2 - Directives générales pour la formation de dénominations communes internationales applicables aux substances pharmaceutiques*
Ver el documentoAnexo 1 - Procedimiento de selección de denominaciones comunes internacionales recomendadas para las sustancias farmacéuticas
Ver el documentoAnexo 2 - Principios generales de orientación para formar denominaciones comunes internacionales para sustancias farmacéuticas*
 

List of pre-qualified products: 20 August 2003

INN

strength

dosage form

supplier

site

packaging

abacavir

300 mg

tablet

GlaxoSmithKline

UK

blister

abacavir

20 mg/ml

oral solution

GlaxoSmithKline

UK

HDPE (bottle)

abacavir

800 mg

dispersable tablet

Cipla

India

blister

abacavir

5%

cream

Cipla

India

Al tube

abacavir

200 mg

tablet

Ranbaxy

India

blister

abacavir

400 mg

tablet

Ranbaxy

India

blister

aciclovir

800 mg

tablet

Ranbaxy

India

blister

amprenavir

15 mg/ml

oral solution

GlaxoSmithKline

UK

HDPE (bottle)

amprenavir

50 mg
150 mg

capsule

GlaxoSmithKline

France

HDPE (bottle)

ceftriazone

500 mg

inj. subst.

Roche

Switzerland

glass vials

ceftriazone

250 mg

Inj. subst.

Roche

Switzerland

glass vials

ciprofloxacin

750 mg

tablet

Lab. Cinfa

Spain

blister

ciprofloxacin

500 mg

tablet

Lab.Cinfa

Spain

blister

ciprofloxacin

250 mg

tablet

Lab.Cinfa

Spain

blister

ciprofloxacin

100 mg

tablet

Cipla

India

blister

ciprofloxacin

250 mg

tablet

Cipla

India

blister

ciprofloxacin

500 mg

tablet

Cipla

India

blister

ciprofloxacin

750 mg

tablet

Cipla

India

blister

ciprofloxacin

250 mg

tablet

Ranbaxy

India

blister (PVC/Al)

ciprofloxacin

500 mg

tablet

Ranbaxy

India

blister (PVC/Al)

ciprofloxacin

750 mg

tablet

Ranbaxy

India

blister (PVC/Al)

clarithromycin

250 mg

tablet

Ranbaxy

India

blister (PVC/PVDC/Al)

clarithromycin

500 mg

tablet

Ranbaxy

India

blister (PVC/PVDC/Al)

cotrimoxazole

200 + 40 mg syrup

 

Roche

Switzerland

amber glass bottle

cotrimoxazole

800 +160 mg tablet

 

Roche

Switzerland

blister (PVC/Al)

cotrimoxazole

400 + 80 mg tablet

 

Roche

Switzerland

blister

didanosine

25 mg

tablet

Bristol Myers Squibb

France

HDPE (bottle)

didanosine

50 mg

tablet

Bristol Myers Squibb

France

HDPE (bottle)

didanosine

100 mg

tablet

Bristol Myers Squibb

France

HDPE (bottle)

didanosine

150 mg

tablet

Bristol Myers Squibb

France

HDPE (bottle)

didanosine

200 mg

chew. or dispersable tablet

Bristol Myers Squibb

France

HDPE (bottle)

fluconazole

50 mg

capsule

Ranbaxy

India

blister

fluconazole

100 mg

capsule

Ranbaxy

India

blister

fluconazole

150 mg

capsule

Ranbaxy

India

blister

fluconazole

200 mg

capsule

Ranbaxy

India

blister

ganciclovir

500 mg

Inj. Subst.

Roche

Switzerland

glass vials

indinavir

400 mg

capsule

Hetero Drugs

India

strip (Al), HDPE bottle

lamivudine

150 mg

tablet

Hetero Drugs

India

strip (Al), HDPE bottle

lamivudine

150 mg

tablet

Ranbaxy

India

blister

lamivudine

150 mg

tablet

Cipla

India

blister

lamivudine

50 mg/5ml

solution

Cipla

India

PET (bottle)

lamivudine

150 mg

tablet

GlaxoSmithKline

UK

HDPE (bottle)

lamivudine

10 mg/ml

oral solution

GlaxoSmithKline

UK

HDPE (bottle)

lamivudine+ zidovudine

150/300 mg

tablet

Ranbaxy

India

blister

lamivudine+ zidovudine

150/300 mg

tablet

Cipla

India

blister

lamivudine+ zidovudine

150 mg +
300 mg

tablet

GlaxoSmithKline

UK

blister
HDPE (bottle)

lamivudine+
zidovudine+
abacavir

150 mg+
300 mg+
300 mg

tablet

GlaxoSmithKline

UK

blister
HDPE (bottle)

nelfinavir

250 mg

film

Roche

Spain,

plastic container

mesylate

 

coated tablet

 

Switzerland

 

nelfinavir

0.50 mg

oral

Roche

Switzerland

HDPE (bottle)

mesylate

/ml

suspension

     

nevirapine

200 mg

tablet

Ranbaxy

India

blister

nevirapine

200 mg

tablet

Cipla

India

blister

nevirapine

200 mg

tablet

Boehringer Ingelheim

Germany

blister

nevirapine

50 mg /5ml

oral suspension

Boehringer Ingelheim

USA

HDPE (bottle) + syringe

nevirapine

200 mg

tablet

Hetero Drugs

India

strip (Al)
HDPE (bottle)

ritonavir

100 mg

capsule

Abbott Laboratories

USA
France

HDPE (bottle)

ritonavir

80 mg/ml

oral solution

Abbott Laboratories

UK

PET (bottle)

ritonavir+
lopinavir

33,3 mg +
133,3

capsule

Abbott Laboratories

USA

HDPE (bottle)

ritonavir+
lopinavir

20 mg +
80 mg/ml

oral solution

Abbott Laboratories

UK

PET (bottle)

saquinavir

200 mg

soft capsule

Roche

Germany

glass bottle

saquinavir

200 mg

capsule

Roche

Switzerland

glass bottle

stavudine

15 mg

capsule

Bristol Myers Squibb

France

blister
HDPE (bottle)

stavudine

20 mg

capsule

Bristol Myers Squibb

France

blister
HDPE (bottle)

stavudine

30 mg

capsule

Bristol Myers Squibb

France

blister
HDPE (bottle)

stavudine

40 mg

capsule

Bristol Myers Squibb

France

blister
HDPE (bottle)

sulfadiazine

500 mg

tablet

Doms Recordati

France

blister

vinblastine sulfate

10 mg /10 ml

injection

Cipla

India

vial

vincristine sulfate

1 mg/ml

injection

Cipla

India

vial

zalcitabine

0.375 mg

tablet

Roche

USA
Switzerland

blister (Al)
glass bottle

zalcitabine

0.75 mg

tablet

Roche

USA

blister (Al)
glass bottle

zidovudine

100 mg

capsule

Combino

Spain

strip (Al)

zidovudine

250 mg

capsule

Combino

Spain

blister PVC/AI

zidovudine

300 mg

capsule

Combino

Spain

blister PVC/AI

zidovudine

300 mg

tablet

Ranbaxy

India

blister

zidovudine

300 mg

tablet

Cipla

India

blister

zidovudine

100 mg

capsule

Cipla

India

HDPE (bottle)

zidovudine

50 mg/5ml

solution

Cipla

India

PET (bottle)

zidovudine

100 mg

capsule

GlaxoSmithKline

UK

blister
amber glass bottle

zidovudine

250 mg

capsule

GlaxoSmithKline

UK

blister

zidovudine

10 mg/ml

infusion

GlaxoSmithKline

USA

amber glass vial

zidovudine

50 mg/5 ml

oral solution

GlaxoSmithKline

UK

amber glass bottle

zidovudine

300 mg

tablet

GlaxoSmithKline

UK

blister (PVC/Al)
amber glass bottle

zidovudine

300 mg

tablet

Hetero Drugs

India

strip (Al)
HDPE bottle

Al:

aluminium

HDPE:

high density polyethylene

PET:

polyethylene terphthalate

PVC:

polyvinyl chloride

PVDC:

polyvinylidene chloride

* More information on pre-qualification/assessment of manufacturing sites is available on the project website at http://www.who.int/medicines

List of generic antiretroviral products and manufacturers

INN

strength

dosage form

supplier

country of origin

indinavir

400 mg

capsule

Hetero Drugs

India

lamivudine

150 mg

tablet

Hetero Drugs

India

lamivudine

150 mg

tablet

Ranbaxy

India

lamivudine

150 mg

tablet

Cipla

India

lamivudine

50 mg/5 ml

solution

Cipla

India

lamivudine + zidovudine

150/300 mg

tablet

Ranbaxy

India

lamivudine + zidovudine

150/300 mg

tablet

Cipla

India

nevirapine

200 mg

tablet

Ranbaxy

India

nevirapine

200 mg

tablet

Cipla

India

nevirapine

200 mg

tablet

Hetero Drugs

India

zidovudine

100 mg

capsule

Combino

Spain

zidovudine

250 mg

capsule

Combino

Spain

zidovudine

300 mg

capsule

Combino

Spain

zidovudine

300 mg

tablet

Ranbaxy

India

zidovudine

300 mg

tablet

Cipla

India

zidovudine

100 mg

capsule

Cipla

India

zidovudine

50 mg/5 ml

solution

Cipla

India

zidovudine

300 mg

tablet

Hetero Drugs

India

 

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Última actualización: le 3 mayo 2013