P R 0 P 0 S E D INN L I S T 95
`INTERNATIONAL NONPROPRIETARY NAMES
`FOR PHARMACEUTICAL SVBSTANCES
`
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`WHO Drug Information Vol 20, No. 2, 2006
`
`World Health Organization
`
`WHO Drug Information
`
`Regulatory Issues
`Drug Regulation in 2006: vision
`and challenges
`International Conference of Drug
`Regulatory Authorities (ICDRA):
`recommendations
`
`Contents
`Fluoxetine approved for children and
`adolescents
`Withdrawal of marketing application for
`Surfaxin®
`Resumed marketing of natalizumab
`EU Regulation on compulsory licensing
`published
`
`61
`
`61
`
`89
`
`89
`90
`
`90
`
`91
`
`97
`100
`
`Emerging Diseases
`Tissue infectivity and transmissible
`spongiform encephalopathies
`
`ATC/DDD Classification
`ATC/DDD Classification (temporary)
`ATC/DDD Classification (final)
`
`Safety and Efficacy Issues
`Tenofovir and nonsteroidal anti-
`inflammatories: acute renal failure
`Update on status of contraceptive
`skin patch
`SSRI antidepressants linked to lung
`disorder in newborns
`ACE inhibitors and birth defects
`ACE inhibitors and pregnancy
`Gadolinium-containing contrast agents
`and néphrogenic systemic fibrosis
`Gatifloxacin and blood glucose
`disturbances
`
`69
`
`69
`
`70
`70
`71
`
`71
`
`72
`
`Essential Medicines
`WHO Model List of Essential Medicines
`and developed countries: a comparison
`with the Lothian Joint Formulary
`73
`Adherence to WHO's Model List of
`Essential Medicines in two European
`countries
`
`78
`
`Regulatory Action and News
`Transgenic antithrombin alfa approved
`86
`EMEA Management Board moves for
`greater transparency
`Bupropion approved for seasonal
`depression
`Decitabine approved for myelodysplastic
`syndromes
`Medical device innovation initiative
`Topotecan/cisplatin for late-stage cervical
`cancer
`Rapid approval of vaccine for prevention
`of cervical cancer
`Rasagiline approved for Parkinson
`disease
`
`86
`
`86
`
`87
`88
`
`88
`
`89
`
`89
`
`Recent Publications,
`Information and Events
`Interagency Emergency Health Kit 2006 103
`Therapeutic guidelines for rheumatology 103
`Specifications for pharmaceutical
`preparations
`New guidance for pharmacists on
`counterfeit medicines
`Marketed unapproved drugs -
`guide
`WHO guidelines on avian influenza
`WHO analgesic ladder
`Resources for paediatric formulations
`
`103
`
`104
`
`104
`104
`105
`104
`
`policy
`
`Consultation Document
`International Pharmacopoeia: revision
`of monographs for antimalarials and
`draft proposals for antiretrovirals
`Artesunate
`Artesunate tablets
`Lamivudine oral solution
`Lamivudine tablets
`Zidovudine and lamivudine tablets
`
`Proposed International
`Nonproprietary Names:
`List 95
`
`106
`107
`107
`109
`112
`
`115
`
`59
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`WHO Drug Information Vol 20, No. 2, 2006
`
`Regulatory Issues
`
`Drug regulation in 2006: vision and challenges
`
`The Twelfth International Conference of Drug Regulatory Authorities (ICDRA) held in Seoul,
`Republic of Korea, from 3 to 6 April 2006 has once again provided drug regulators with a
`unique opportunity to meet and discuss the particular challenges of medicines regulation. The
`continuing need to harmonize and strengthen collaboration is underscored by the increasing
`complexity of the medicines market and technical skills needed to regulate innovative prod-
`ucts. The latest ICDRA was hosted by the Korea Food and Drug Administration in collabora-
`tion with the World Health Organization. The event was highly appreciated by developed and
`developing countries for its continuing role in fostering a regulatory forum where matters of
`urgency and international relevance can be openly debated. On this occasion, the event led to
`adoption of the following recommendations which regulators consider important in assuring
`the quality, safety and efficacy of medical products.
`
`International Conference of Drug Regulatory
`Authorities (ICDRA): recommendations
`
`Access to medicines: new regulatory
`pathways for public health needs
`
`medicines of quality which address public
`health needs.
`
`1. In the assessment of products, particularly
`those developed for public health needs,
`countries should make use of new regulatory
`pathways provided by highly-evolved regula-
`tory agencies in order to avoid duplication of
`effort. This would enable optimal use of limited
`resources.
`
`2. In cooperation with well resourced regula-
`tory agencies, WHO is urged to assist Mem-
`ber States to provide training on the best use
`of regulatory information on product approvals
`available in the public domain.
`
`3. WHO should continue its efforts to
`prequalify active pharmaceutical ingredients
`for medicines for priority diseases, including
`HIV/AIDS, malaria and tuberculosis. Informa-
`tion concerning prequalified products and
`approved sites should continue to be made
`public in the form of WHO public inspection
`reports.
`
`4. WHO should assist national regulatory
`agencies to develop innovative approaches to
`improve access to safe and effective essential
`
`Emerging diseases and crises
`management: regulatory challenges
`
`1. The fight against emerging diseases
`requires global collaboration and multi-
`disciplinary effort. Member states should
`ensure their national regulatory agencies are
`closely involved in national strategic decision
`making processes and are engaged as key
`stakeholders in national contingency planning.
`In this context, national regulatory agencies
`should develop business continuity plans and
`may also have a role in facilitating vaccine
`and pharmaceutical research and develop-
`ment, and development of blood screening
`tests.
`
`2. WHO should take a leading role in the
`global preparedness for pandemic infections.
`Central to its role as the global leading health
`agency, WHO should cooperate with Member
`States to ensure transparency of epidemio-
`logical information, co-ordinate information
`and technology transfer on clinical trials and
`research and assist Member States through
`developing WHO standards for pre-marketing
`
`61
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`World Health Organization
`
`WHO Drug Information Vol 20, No. 2, 2006
`
`WHO Drug Information
`
`e-mail table of contents
`
`and subscriptions
`
`available at:
`
`http://www.who.int/druginformation
`
`60
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`Proposed INN: List 95
`
`WHO Drug Information, Vol.20, No. 2,2006
`
`4.(1-{4-[2-(dimethylamino)ethoxy]phenyl}-2.phenylbut-1-enyl)phenol
`antiesttogen
`
`4[I-(4.[2.(diméthylamino)ethoxy)phnylJ-2-phenyIbut-1-ényI]phènol
`antioestrogene
`
`4-(1-(4-(2-(dimetilamino)etoxi]fenil]-2-fenhlbut-1-enhl]fenol
`antiestrOgeno
`
`CHNO2
`
`68392-35-8
`
`and Zusomer
`et risomere z
`yellsómeroZ
`
`OH
`
`des-432-lysine-(human vascular endothelial growth factor receptor
`1-(103-204).peptide (containing 19-like C2-type 2 domain) fusion
`protein with human vascular endothelial growth factor receptor
`2.(206-308)-peptide (containing Ig-like C2-type 3 domain fragment)
`fusion protein with human immunoglobulin G1-(227 C-terminal
`residues)-peptide (Fc fragment)], (211-211':214-214')-bisdisulflde
`dimer
`angiogenesis inhibitor
`
`(211-211':214-214')-blsdisulfure du dimère de la dès-432-Iysine-
`(récepteur I humain du facteur de croissance endothélial vasculaire-
`(103.204)-peptide (contenant le domaine Ig-like C2-type 2) protelne
`de fusion avec le recepteur 2 humain du facteur de croissance
`endothélial vascu?aire.(206.308).peptide (contenant un fragment du
`domaine Ig-tike C2-type 3) protélne de fusion avec
`limmunoglobuline Gi humaine-(227 résidus C-terminaux)-peptide
`(fragment Fc)]
`inhibileurde I'angiogbnêse
`
`(211-211':214-214')-blsdisulfuro del dimero de la des-432-lisina-
`(receptor 1 humano del factor de crecimiento endotellal vascular-
`(103-204)-peptido (que contiene el dominio Ig-like C2-tlpo 2)
`protelna de fuslbn con el receptor 2 humano del factor de
`crecimlento endotellal vascular-(206-308)-péptldo (que conhiene un
`fragmento del dominio 19-like C2-tipo 3) protelna de fusion con Ia
`Inmunoglobulina GI humana.(227 restos C-terminales)-péptldo
`(fragmento Fc)]
`inhibidor de la angiogenesis
`
`atimoxifenum
`afimoxifene
`
`afimoxiféne
`
`atimoxifeno
`
`afllberceptum*
`aflibercept
`
`aflibercept
`
`aflibercept
`
`118
`
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`WHO Drug Information, Vol.20, No. 2, 2006
`
`Proposed CNN; List 95
`
`C43I8HOOON11MOIOOS32
`
`845771-78-0
`
`Monomer I Monomre I Mondmcro
`SDTGRPFV4 YSE1PE11014 TCGRELVIPC RV'rspNrrv-r LKIcFPLDTLI 30
`PDGKRhIt4DS RKGFIISNAT YKEIGL1TCE ATVNGHLYKI' NYLTIIRQTNT 100
`IIDVVLSPSH GIELSVGEKL VLNCTAP.10L NVGIDFOIWEY PSSXIIQIIKKL ISO
`V00RDLKrOSG SES4KKFLSTL Tlroevrp.SDO GLYTCM,SSG LSOTKK305TSV 200
`RVIOEKDIVS'HT CPPCPAPELL GGPSVFLFPP KPKDTLHISR TPCVTCVVVD 250
`VSHEDPEVKF NWYVDGVEVH NAKTKPREEO YNSTYRWSV LTVLIOODWLK 300
`GKEYKCKVSN KALPAPIEK'I ISKAKGQPRE PQVYTLPPSR DLTKNOVSL 310
`TCLVKGFYPS DIAVEWESHG OPENNYKTTP PVLOSDGSFF LYSKLT'IDKS 400
`01000GNVFSC SVMHEAL000 YTQKSLSLSP G
`431
`
`Disulfide bodges locotzonl Position des poets disulfurc/ Posicottcs do los puastes disulfuro
`30.70
`30.70 524.113 I24.II$ 211.211
`214.214' 240.306 240.306 332-410 332.417
`
`(2S)-2-methoxy-3-{4-(2-(5.methyl.2-phenyl-1,3-oxazol-4.yl)ethoxyj-
`1-benzothiophen.7-yl}propanoic acid
`anfidiabetic
`
`acide (2S)-2-méthoxy-3-[4-[2-(5-méthyl-2-phényl.1,3.oxazol-4.yl)=
`ethoxyl.1-benzothiophen-7-yl]propanoTque
`anhidiabétique
`
`bcido (2S)-3-{4-12-(2-fenil-1,3-oxazol-5-metil-4-ll)etoxl]-
`l-benzotiofen-7.il}.2.meto)ipropanoico
`hipoglucemiante
`
`C24HNO5S
`
`475479-34-6
`
`aleglitazarum
`ateglitazar
`
`aléglitazar
`
`aleglitazar
`
`alferminogenuin tadenovecum*
`alferminogene tadenovec
`
`atferminogene tadénovec
`
`alferminogén tadenovec
`
`Recombinant human adenovirus 5 (replication-deficient, El-deleted)
`containing a human fibroblast growth factor-4 cDNA sequence driven
`by a cytomegatovirus promoter
`gene therapy product- stimulates angiogenesis
`
`adénovirus 5 humain recombinant (répticallon-déficlent,
`region El-suppnmée) contenant la sequence ADN-copie du
`facteur4 de croissance du fibroblaste humain sous contrOte dun
`promoteur de cytomégalovirus
`produit de therapie genique stimulateur de l'angiogenOse
`
`adenovirus 5 humano recombinante (repilcacion-deficlente, con
`delecclón El) que contiene la secuencia DNA-copia del factor-4 de
`crecimiento de fibroblastos humanos controlado por un promotor de
`citomegalovirus
`producto para genoterapia,estimulante de la angiogOnesis
`
`473553-86-5
`
`119
`
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