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WHO Drug Information

A quarterly journal providing an overview of topics relating to medicines
development and regulation

targeted to a wide audience of health professionals and policy makers

 <http://www.who.int/druginformation> www.who.int/druginformation

WHO Drug Information Digital Library

(Search engine for Volumes 1-21 from 1987 to 2007)




WHO Drug Information, Volume 26 Number 2

The second issue for 2012 features an article on the WHO Prequalification of
Medicines Programme which, since 2009, has been hosting and coordinating a
novel quality risk assessment mechanism on behalf of the Global Fund to
Fight AIDS, Tuberculosis and Malaria. The Expert Review Panel assesses
quality risks of pharmaceutical products which do not yet meet stringent
quality requirements. Based on standardized, transparent criteria, it gives
advice on whether a product is acceptable for procurement for the next 12
months. The process has promoted progression of many medicines to
prequalification: of 115 eligible products assessed by the Expert Review
Panel in 2009 and 2010, 44 went on to become prequalified or approved by a
stringent regulatory authority. Agencies are using the mechanism jointly and
this has resulted in harmonized quality assurance policies, unified quality
standards and efficiency gains.

The section on Safety and Efficacy highlights information on signals and
reports of adverse drug reactions, with other news from around the world,
including labelling changes. This is complemented by the section on
Regulatory Action and News which provides the most recent developments from
regulatory authorities, and particularly those having an impact on
decision-making and risk assessment. 

The final and temporary lists of ATC/DDD Classifications adopted by the WHO
International Working Group for Drug Statistics Methodology are also

The final section, Recent Publications, Information and Events, provides
brief summaries of several recently-published documents and online

The journal concludes with the 107th Proposed List of International
Nonproprietary Names (INN).



WHO Prequalification of Medicines Programme

The Expert Review Panel                                                  97

Safety and Efficacy Issues

Tolvaptan: risk of serious neurological events                  109

Strontium ranelate: new contraindications and revised warnings  109

Fingolimod: new safety advice                                   109

Pioglitazone: bladder cancer                                            110

Benzocaine: new risk statements                                         110

Minocycline: lupus erythematosus and autoimmune hepatitis       110

Domperidone maleate: ventricular arrhythmias and cardiac death  111

Vandetanib: risk of fatal outcome                                       112

Finasteride and dutasteride: prostate cancer                    112

Lenalidomide: increased malignancies                            112

Antithrombotic medicines and bleeding                           113

Belimumab: hypersensitivity and infusion reactions                      113

Escitalopram: abnormal heart rhythm                             113

Empowering patient ADR reporting                                        114

Regulatory Action and News

Commercially confidential information and personal data                 115

Pyronaridine and artesunate: new anti-malarial approved                 115

Aprotinin: suspension lifted                                            116

Pixantrone: conditional approval for non-Hodgkin B-cell lymphoma        116

Levofloxacin approved for plague                                        116

Pazopanib: approved for soft tissue sarcoma                     117

Capsaicin: withdrawal of marketing authorization application    117

Rivastigmine: withdrawal of marketing authorization application         118

Megestrol: withdrawal of marketing authorization application    118

Lapatinib: withdrawal of marketing authorization application    118

ATC/DDD Classification

ATC/DDD Classification (temporary)                                      119

ATC/DDD Classification (final)                                  122

Recent Publications, Information and Events

Evolving threat of antimicrobial resistance                             125

Safety of medicines in sub-Saharan Africa                               125

International meeting of world pharmacopoeias                   126

Interagency emergency health kit 2011                           126

Guide on estimating pain medication requirements                        127

Persisting pain in children: treatment guidelines                       127

Consultation Documents

The International Pharmacopoeia

Levonorgestrel and ethinylestradiol tablets                             128

Mefloquine hydrochloride                                                132

Fluconazole                                                             136

Fluconazole capsules                                            141

Fluconazole injection                                                   144

Sulfamethoxazole and trimethoprim intravenous infusion          147

Sulfamethoxazole and trimethoprim oral suspension               152

International Nonproprietary Names

Proposed List No. 107                                           157



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