ST/ESA/ 322 Department of Economic and Social Affairs Consolidated List of Products Whose Consumption and/or Sale Have Been Banned, Withdrawn, Severely Restricted or not Approved by Governments Fourteenth Issue (New data only) (January 2005 – October 2008) Pharmaceuticals United Nations – New York, 2009 DESA The Department of Economic and Social Affairs of the United Nations Secretariat is a vital interface between global policies in the economic, social and environmental spheres and national action. The Department works in three main interlinked areas: (i) it compiles, generates and analyses a wide range of economic, social and environmental data and information on which Member States of the United Nations draw to review common problems and to take stock of policy options; (ii) it facilitates the negotiations of Member States in many intergovernmental bodies on joint courses of action to address ongoing or emerging global challenges; and (iii) it advises interested Governments on the ways and means of translating policy frameworks developed in United Nations conferences and summits into programmes at the country level and, through technical assistance, helps build national capacities. NOTE Symbols of United Nations documents are composed of the capital letters combined with figures. Mention of such a symbol indicates a reference to a United Nations document. Applications for the right to reproduce this work or parts thereof are welcomed and should be sent to the Secretary, United Nations Publication Board, United Nations Headquarters, New York, N.Y. 10017, United States of America. Governments and governmental institutions may reproduce this work or parts thereof without permission, but are requested to inform the United Nations of such reproduction. ST/ESA/322 UNITED NATIONS PUBLICATION Sales No. E.09.IV... ISBN 92-1-130232- … Copyright ©United Nations 2009 All rights reserved Printed in the United Nations, New York TABLE OF CONTENTS Introduction …………………………………………………………..……………..….. v Alphabetical Listing of products ……..………………………………..….….…...….... vii List of codes for countries, territories and areas ………………………...…….….…… ix PART I. REGULATORY INFORMATION Pharmaceuticals (monocomponent products) …………..……………..…….…...….. 3 Pharmaceuticals (combination and group products) ……………….…...……...........29 PART II. COMMERCIAL INFORMATION Pharmaceuticals (trade names) …………………………………......……...……......39 INDEXES A. Index by Chemical Abstract Service (CAS) Registry numbers ………..…….…43 B. Index to Pharmaceuticals by scientific and common names, and synonyms….. .47 C. Index to Pharmaceuticals by available trade names ….………………..….....….51 ANNEXES I. Relevant resolutions of the General Assembly and Economic and Social Council ……………………………………………………......…….. 55 II. Criteria for the inclusion of pharmaceutical and chemical products in the Consolidated List ……………………………………... ……..…...……75 III. List of references cited in the regulatory text………..…. ……………….……. 77 IV. Questionnaire ……………………………………………………...…….………81 INTRODUCTION As before, the next, fourteenth issue resolution 39/229 called for the List data to of the Consolidated List of Products whose be made available to Governments and other Consumption and/or Sale have been users in such a form as to permit direct Banned, Withdrawn, Severely Restricted or computer access to it, and ECOSOC not Approved by Governments, is published resolution 2001/33, requested the Secretary- in a “short version”, for limited distribution General to look at the possibility of online in printed form, and as usual, it will contain dissemination of the List data. only new data. The updated fourteenth issue of the Consolidated List, containing new as Accordingly, beginning with the well as historical data on pharmaceuticals, is ninth, updated issues of the List are posted now available on the internet at the DESA regularly on the above mentioned website. website www.un.org/esa/coordination under In order to provide complete and up to date publications. coverage of both pharmaceuticals and chemicals, two most recent issues are The short version is continued to be maintained on the web site. It is hoped that printed for the benefit of the List users, this new procedure will help the List to particularly for those in the developing reach a much wider audience in a shorter countries, who may not have easy access to period of time, as mandated in previously the Internet or for those who would like to mentioned and other General Assembly and continue to receive the publication in the ECOSOC resolutions. printed version for reasons of their own. In this regard, it should be understood that to The fourteenth issue of the List obtain complete coverage, the present issue contains data received by WHO from could only be used in conjunction with the national authorities on new regulatory previously printed even numbered issues, decisions and from voluntary withdrawals of focused as well on pharmaceuticals data. products by manufacturers on grounds of safety. It may also include other drug- According to an agreed rotation related information issued by WHO through schedule, the yearly focus of the WHO Rapid Alerts, WHO Pharmaceuticals Consolidated List alternates between Newsletter and the journal WHO Drug pharmaceuticals (even numbered issues) and Information. chemicals (odd numbered issues). The seventh issue of the List, containing This printed version contains chemicals data, was the last issue to be information received from 24 countries, six published in the printed version only. The of them (China, Cameroon, Kenya, Serbia, eighth issue of the List, containing data on Timor-Leste and Ukraine) reporting for the pharmaceuticals, became the first issue to be very first time on pharmaceuticals. It printed as well as posted on the United includes data on 66 new products, together Nations Economic and Social Council with updated and/or new information on 22 (ECOSOC) website in September 2003, in existing products. No new data was accordance with the General Assembly and collected on commercial information ECOSOC resolutions (see annex I). regarding available proprietary trade/brand More specifically the General Assembly names of new pharmaceutical products included in this issue. v ALPHABETICAL LISTING OF PRODUCTS Product name Page ACE inhibitors and Angiotensin II receptor antagonists .…………………………………………………………….…..…… 29 Acetylsalicylic acid (paediatric) ….………………………………………………………………………………………..….…... 3 Alefacept ……………………………………………………………………………………………………………….…………... 3 Alendronic acid and other bisphosphonates …………………………………………………………………………………….. 29 Alimemazine - Paracetamol teething mixture ……………………………………………………………………………...…..… 29 Amlodipine …………………………………………………………………………………………………………………....…… 3 Antidepressants …………………………………………………………………………………………………………….…….. 29 Antiretroviral agents ……………………………………………………………………………………………………….…….. 30 Aprotinin ……………………………………………………………………………………………………………………..…… 3 Astemizole …………...……………………………………………………………………………………………..……….…….. 4 Atazanavir-Ritonavir …………………………………………………………………………………………………………….. 30 Attention-Deficit/Hyperactivity Disorder (ADHD) drugs …………………………………………………………………..…. 30 Betamethasone and other potent corticosteroids for topical use ………………………………………………………………. 31 Black Cohosh (Cimicifugae racemosae)-containing products ………………………………………………………….……… 31 Buflomedil ……………………………………………………………………………………………………………………..…. 4 Cabergoline …………..…………………………………………………………………………………………………………... 4 Carbamazepine …………………………………………………………………………………………………………………... 5 Ceftriaxone …………………………………………………………………………………………………………………… …. 5 Chelidonium extract ………………………………………………………………………………………………………………. 31 Chlorproguanil and Dapsone …………………………………………………………………………………………………….. 32 Cinacalcet ……………………………………………………………………………………………………………………...….. 5 Cisapride ……………………………………………………………………………………………………………………..…… 6 Clobutinol …………………………………………………………………………………………………………………………. 6 Clobutinol-containing cough preparations ……………………………………………………………………………………… 32 Codeine …………………………………………………………………………………………………………………………….. 6 Cyclo-oxygenase-2 (COX-2) Inhibitors …………………………………………………………………………………..……… 32 Cyproterone acetate and ethinylestradiol ……………………………………………………………………………………….. 33 Desmopressin nasal spray …………………………………………………………………………………………………..…….. 7 Dextropropoxyphene-paracetamol …………………………………………………………………………………….………… 33 Dolasetron …………………………………………………………………………………………………………………………. 7 Drug-eluting stents ………………………………………………………………………………………………………..….…… 34 Ephedrine and pseudoephedrine containing OTC products ………………………………………………………………….. 34 Ephedrine ………………………………………………………………………………………………………………………….. 7 Ergometrine ………………………………………………………………………………………………………………………. 8 Estradiol-testosterone injection …………………………………………………………………………………………………. 34 Gatifloxacin ……………………………………………………………………………………………………………….…..…... 8 Glucosamine ………………………………………………………………………………………………………………..…….. 8 Hydromorphone hydrochloride …………………………………………………………………………………………………. 8 Ingalipt (Combination aerosol) …………………………………………………………………………………………….……. 35 Interferon-gamma-1 b ……………………………………………………………………………………………………….…... 9 Isotretinoin …………………………………………………………………………………………………………………..……. 9 Ketamine ……………………………………………………………………………………………………………………...…... 10 Ketoconazole ……………………………………………………………………………………………………………………….. 10 Lamotrigine ………………………………………………………………………………………………………………………... 10 L-arginine (1-arginine) ……………………………………………………………………………………………………………. 11 Lidocaine …………………………………………………………………………………………………………………………... 11 Lindane …………………………………………………………………………………………………………………………….