DOCSLIB.ORG

Mm Mm Mum Um 115:0 11116151113" Lllll ||||| Lllilllll |||||

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Mm Mm Mum Um 115:0 11116151113 mm mm mum um 115:011116151113" lllll ||||| lllilllll ||||| 1|! United States Patent [191 [11] Patent Number: 5,565,443 Lanquetin et al. [45] Date of Patent: Oct. 15, 1996 [54] SUBCUTANEOUS IMPLANTS BASED ON [58] Field of Search ................................... .. 514/169, 170, NORMEGESTROL DERIVATIVES 514/177, 178, 179, 182; 424/422, 423, 424, 425, 426, 484, 485, 486, 487, 488 [75] Inventors: Michel Lanquetin, La Trinite; Jean-Louis Thomas, [56] References Cited Charentron-le-Pont; Jacques Paris, U.S. PATENT DOCUMENTS Nice, all of France; Elsimar Coutinho, Salvador Bahia, Brazil 4,147,783 4/1979 van der Vies ......................... .. 424/243 4,172,132 10/1979 Draper et a1. .... .. 424/243 [73] Assignee: Laboratoire Theramex S.A., Monaco 4,456,601 6/1984 Toth et a1. .... .. 424/241 4,544,555 10/1985 Gastaud ......... .. 260/3974 [21] Appl. No.: 244,098 5,223,492 6/1993 Nasraoui et a1. ..................... .. 514/172 [22] PCT Filed: Sep. 17, 1993 OTHER PUBLICATIONS [86] PCT No.: PCT/FR93/00900 Nash et al “Steroid Release From Silastic Capsules and Rods” Contraception Oct. 1978, vol. 18, No. 4, pp. 367—394. §3‘71 Date: Jul. 6, 1994 Metzker “One Year Contraception with a Single Subdermal Implant Containing Nornegestrol Acetate” Contraception § 102(e) Date: May 17, 1994 vol. 47, pp. 97-105. [87] PCT Pub. No.: W094/06437 Primary Examiner—Nathan M. Nutter PCT Pub. Date: Mar. 31, 1994 Attorney, Agent, or Firm-Biennan and Muserlian [30] Foreign Application Priority Data [57] ABSTRACT Sep. 21, 1992 [FR] France ................................. .. 92 11422 Subcutaneous implant for preventing conception for at least one year in women comprising an amount effect to prevent [51] Int. Cl.6 ................................................... .. A61K 31/56 conception without suppressing intermontly bleeding of a [52] US. Cl. ........................ .. 514/169; 514/170; 514/177; steroid compound of formula I or formula H and a physi 514/178; 514/179; 514/182; 424/422; 424/423; ologically-tolerable pharmaceutical carrier. 424/424; 424/425; 424/426; 424/484; 424/485; 424/486; 424/487; 424/488 12 Claims, 5 Drawing Sheets US. Patent Oct. 15, 1996 Sheet 1 of 5 5,565,443 024 6 8 l0 l2 MONTHS MONTHS F 1 G. | A F I G. | B awmso C: 3%@50 _.EH E m m a mm m H m m H a a WM m WMM WWW’ WM a H H e o 2 4 e 8 IO l2 MONTHS MONTHS F l G. | C F l G. ID US. Patent Sheet 2 of 5 5,565,443 60 50 40? O x 30 20 O / INCLUSION MONTH\\\\\\\\\\\ I2 MEAN=56,26 ES=l,l4 MEAN=57,34 ES=I,I7 FIG. 2A 120* no I00 0, 90 I E 80 E 70 60% 50 \\\\\\\\\\\\‘ SY ST OLIC DIA SYSTOLIC DIASTOLIC INCLUSIO MONTH 12 FIG.2B U.S. Patent Oct. 15, 1996 Sheet 3 of 5 5,565,443 Po M / V ______ /// // 7 30.0 Ew8642O PROGESTERONE (?g/ml) FIG. 3 US. Patent 0a. 15, 1996 Sheét 4 0f 5 5,565,443 q — 9mm N __ w.m - wmm 0mm1 COM 0mm OQN Ovm. ONN OON US. Patent Oct. 15, 1996 Sheet 5 0f 5 5,565,443 wP<JDwnZOZmQ+ wMO_m m><o w 0.9m _ mvm 0mml 0Q 000. LOmN 0mm 0% 8m oow 09m1 5,565,443 1 2 SUBCUTANEOUS [MPLANTS BASED ON Among the implants which utilize hydrophobic materials NORMEGESTROL DERIVATIVES it may be cited: the implants of container type prepared from polydim This invention relates to novel compositions endowed ethyl siloxanes such as for example SILASTIC® with progestative action and the processes for their produc (medical grade of dimethylpolysiloxane made by Dow tion. Corning) produced by the company Dow Coming. This It has more particularly as a subject matter novel com kind of implant is shown in the form of a tube having positions intended to insure protracted contraception. an external diameter comprised between 2 and 4 mm Speci?cally it has as a subject matter, a preparation in the and having a thickness of about 0.4 mm. The portions form of a subcutaneous implant containing an effective of tubing are cut at the selected lengths as a function of amount of a derivative of 3-substituted 6-methyl 17ot-OR1 the amount of nor pregnadiem'c compound which is 20-oxo 19-nor pregna 4,6-dien selected from the group ' desirably incorporated. The ends of these portions of consisting of tube are closed using a glue of medical quality also sold a) 3,20-dioxo 6-methyl l7ot-OR1 l9-nor pregna 4,6-diens by the company Dow Coming and which belongs to the of general formula I group of silicones RTV (Room Temperature Vulcaniz ing). CH3 (1) The amount of nor pregnadienic compound of formulae 1, II or III incorporated in the portion of the tube, ranges from 30 to 80 mg and preferably from 45 to 65 mg. This content of active ingredient is namely determined by the granulo 20 metric properties of the active ingredient which may be micronized or microcristallized and by its physico-chemical characteristics (molecular weight, solubility, diffusibility, partition index). The way of incorporation of the active CH3 ingredient may be done either in the solid state or dispersed wherein R1 is a hydrogen, or the acyl moiety of an organic 25 in a biologically acceptable and inert carrier. aliphatic, aromatic or cyclanic carboxylic acid having from The manner of preparation and isolation of the microc 2 to 16 carbon atoms rystallized forms of the compounds of this invention have b) the substituted 3-OR2 6-methyl l'lot-OR1 20-oxo already been described in the french patent application l9-nor pregna 4,6-diens of general formula II 2.668.945 in the name of the applicant. 30 implants of the container type produced from ethylene/ CH3 (II) vinyl acetate copolymers such as for example the material sold under the Trade Name ELVAX® MD 40 (ethylene-vinyl acetate copolymer) by the company 35 DUPONT de NEMOURS. This kind of implant has already been utilized for the intra uterine device Progestasert® containing an hormonal preparation R20 made by Alza, but contrarily to Progestasert in the case of the implants of this invention, the active ingredient CH3 is introduced in a solid form. wherein R1 has the above-given de?nitions and R2 is a hydrogen, the acyl moiety of carboxylic acid, or an alkyl implants of the matrix type, produced from polydimethyl radical having from 1 to 8 carbon atoms and siloxanes. This kind of implant has already been used in man (Nash, Robertson and cowork—Contraception c) the 6-methyl l7ot-OR1 19-nor pregna 4,6-diens of 18 (1978) p.367). This implant of the matrix type general formula III } 45 namely presents the inconvenient of a high rate of CH; (111) release of the active ingredient. In order to compensate this disadvantage, the implants according to this inven tion have to be produced in introducing one of the derivatives according to the formulae I, II or III sus 50 pended in a hydrophilic liquid in which the active ingredient is insoluble. This suspension is admixed to the poly dimethyl siloxanes then the whole mass is cross-linked before to proceed to the extrusion of the elastomer in the form of a cylindrical thread having the wherein R1 is de?ned as above R3 and R4 together form I choosen measures. This process allows the obtention of either an oximido grouping of formula =N-—~O—R5 kinetics of release of zero order and no longer as a wherein R5 is a hydrogen, a lower alkyl or a carboxyalkyl function of the square root of time such as the matrix group or an alkylenedioxy grouping which may be substi cited by Nash and co-workers. tuted or each are a lower alkoxy radical in admixture or implants of the matrix type produced from ethylene-vinyl conjunction with a carrier and with a biologically acceptable acetate copolymers. In this case the implant is prepared diluent. by casting. Due to its monolithic structure, this implant The implants according to this inventions are made of releases the active ingredient along a kinetic of the type polymeric materials (hydrophobic, hydrophilic or biode square root of the time. The partial coating using a gradable) used as vectors of pharmacologically-active com membran which serves to control the release from the pounds previously included in the formulae I, II or III. matrix, may be realized either with an EVA polymer The implants namely are of the container type or of the having a lower concentration of vinyl acetate or in matrix type. introducing the matrix in a tube of polydimethyl silox 5,565,443 3 4 ane (type SILASTIC) to obtain release curves of zero extend over about 6 months, frequently joined with signi? order. cant side-effects. Among the implants using hydrophilic materials it may be This is the reason why the experimenters have been cited: coming to the implants in biocompatible polymers which are implants of matrix type produced from hydroxyethyl 5 inserted either in the uterine cavity (PROGESTASERT(R)) polymethacrylates such as for example HYDRON® (a or in the subcutaneous tissues (implants). gel based on hydroxyethyl polymethacrylate) manufac It thus has been experienced implants containing numer tured by the company HYDRON HED SCIENCES. ous steroidal active ingredients with progestational activity, This kind of implant is produced by polymeration in such as norgestrienone, norethindrone or levonorgestrol. alcohol followed by a cross-linking by means of eth~ 10 However with these products, it is necessary for obtaining ylene glycol dimethylacrylate.
Load more

Recommended publications
  • Annex 2 Composition of Oral and Injectable Estrogen–Progestogen Contraceptives
    ANNEX 2 COMPOSITION OF ORAL AND INJECTABLE ESTROGEN–PROGESTOGEN CONTRACEPTIVES Annex 2 lists the composition of brands of estrogen–progestogen preparations used in combined injectables (Table 1), combined oral (Table 2) and phasic oral (Table 3) contraceptives. The countries in which these formulations are used are noted. Are listed only those brands for which availability was reported. The source of these tables is the International Planned Parenthood Foundation (IPPF). Data have been taken from the IPPF 2002 website [http://contraceptive.ippf.org] at the time of the monograph meeting (June 2005). This online site is regularly updated. Table 1. Combined injectables Brand name Composition Countries of availability Acefil Dihydroxyprogesterone acetophenide 150 mg Paraguay + estradiol enanthate 10 mg Agurin Dihydroxyprogesterone acetophenide 150 mg Chile + estradiol enanthate 10 mg Anafertin Dihydroxyprogesterone acetophenide 75 mg El Salvador, Mexico + estradiol enanthate 5 mg Ciclofem Medroxyprogesterone acetate 25 mg Guatemala + estradiol cypionate 5 mg Ciclofemina Medroxyprogesterone acetate 25 mg El Salvador + estradiol cypionate 5 mg Ciclomes Dihydroxyprogesterone acetophenide 150 mg Paraguay + estradiol enanthate 10 mg Ciclovular Dihydroxyprogesterone acetophenide 150 mg Brazil + estradiol enanthate 10 mg Clinomin Dihydroxyprogesterone acetophenide 150 mg Paraguay + estradiol enanthate 10 mg Cyclofem Medroxyprogesterone acetate 25 mg Chile, Indonesia, Malaysia, Mexico, + estradiol cypionate 5 mg Panama, Zimbabwe Cyclofemina Medroxyprogesterone
    [Show full text]
  • BMJ Open Is Committed to Open Peer Review. As Part of This Commitment We Make the Peer Review History of Every Article We Publish Publicly Available
    BMJ Open is committed to open peer review. As part of this commitment we make the peer review history of every article we publish publicly available. When an article is published we post the peer reviewers’ comments and the authors’ responses online. We also post the versions of the paper that were used during peer review. These are the versions that the peer review comments apply to. The versions of the paper that follow are the versions that were submitted during the peer review process. They are not the versions of record or the final published versions. They should not be cited or distributed as the published version of this manuscript. BMJ Open is an open access journal and the full, final, typeset and author-corrected version of record of the manuscript is available on our site with no access controls, subscription charges or pay-per-view fees (http://bmjopen.bmj.com). If you have any questions on BMJ Open’s open peer review process please email [email protected] BMJ Open Pediatric drug utilization in the Western Pacific region: Australia, Japan, South Korea, Hong Kong and Taiwan Journal: BMJ Open ManuscriptFor ID peerbmjopen-2019-032426 review only Article Type: Research Date Submitted by the 27-Jun-2019 Author: Complete List of Authors: Brauer, Ruth; University College London, Research Department of Practice and Policy, School of Pharmacy Wong, Ian; University College London, Research Department of Practice and Policy, School of Pharmacy; University of Hong Kong, Centre for Safe Medication Practice and Research, Department
    [Show full text]
  • Literature Review of Organic Chemicals of Emerging Environmental Concern in Use in Auckland December TR 2008/028
    Literature Review of Organic Chemicals of Emerging Environmental Concern in Use in Auckland December TR 2008/028 Auckland Regional Council Technical Report No.028 December 2008 ISSN 1179-0504 (Print) ISSN 1179-0512 (Online) ISBN 978-1-877483-69-1 Technical Report, first edition Reviewed by: Approved for ARC publication by: Name: Judy-Ann Ansen Name: Paul Metcalf Position: Team Leader Position: Group Manager Stormwater Action Team Environmental Programmes Organisation: Auckland Regional Council Organisation: Auckland Regional Council Date: 1 November 2008 Date: 1 October 2009 Recommended Citation: AHERNS, M., 2008. Review of Organic Chemicals of Potential Environmental Concern in Use in Auckland. Prepared by NIWA for Auckland Regional Council. Auckland Regional Council Technical Report 2008/028. © 2008 Auckland Regional Council This publication is provided strictly subject to Auckland Regional Council's (ARC) copyright and other intellectual property rights (if any) in the publication. Users of the publication may only access, reproduce and use the publication, in a secure digital medium or hard copy, for responsible genuine non-commercial purposes relating to personal, public service or educational purposes, provided that the publication is only ever accurately reproduced and proper attribution of its source, publication date and authorship is attached to any use or reproduction. This publication must not be used in any way for any commercial purpose without the prior written consent of ARC. ARC does not give any warranty whatsoever, including without limitation, as to the availability, accuracy, completeness, currency or reliability of the information or data (including third party data) made available via the publication and expressly disclaim (to the maximum extent permitted in law) all liability for any damage or loss resulting from your use of, or reliance on the publication or the information and data provided via the publication.
    [Show full text]
  • Progestagens for Human Use. Exposure and Hazard Assessment for the Aquatic Environment J.P
    Progestagens for human use. Exposure and hazard assessment for the aquatic environment J.P. Besse, J. Garric To cite this version: J.P. Besse, J. Garric. Progestagens for human use. Exposure and hazard assessment for the aquatic environment. Environmental Pollution, Elsevier, 2009, 157 (12), p. 3485 - p. 3494. 10.1016/j.envpol.2009.06.012. hal-00455636 HAL Id: hal-00455636 https://hal.archives-ouvertes.fr/hal-00455636 Submitted on 10 Feb 2010 HAL is a multi-disciplinary open access L’archive ouverte pluridisciplinaire HAL, est archive for the deposit and dissemination of sci- destinée au dépôt et à la diffusion de documents entific research documents, whether they are pub- scientifiques de niveau recherche, publiés ou non, lished or not. The documents may come from émanant des établissements d’enseignement et de teaching and research institutions in France or recherche français ou étrangers, des laboratoires abroad, or from public or private research centers. publics ou privés. Environmental Pollution, vol. 157, n° 12, doi : 10.1016/j.envpol.2009.06.012 1 Progestagens for human use, exposure and hazard assessment for 2 the aquatic environment 3 4 5 6 Reviewed version of manuscript ENVPOL-D-09-00080R1. 7 The abstract of this paper was evaluated and approved by Dr Wiegand. 8 9 10 Authors 11 12 Jean-Philippe BESSE a* 13 Jeanne GARRIC a** 14 15 a Unité Biologie des écosystèmes aquatiques. Laboratoire d’écotoxicologie, 16 Cemagref, 3bis quai Chauveau CP 220 69336 Lyon cedex 09, France 17 Tel.: +33 472208902 18 19 * first author 20 ** corresponding author. E-mail address: [email protected] 21 22 23 Capsule: 24 Gestagens exposure and hazard assessment for the aquatic environment.
    [Show full text]
  • Federal Register / Vol. 60, No. 80 / Wednesday, April 26, 1995 / Notices DIX to the HTSUS—Continued
    20558 Federal Register / Vol. 60, No. 80 / Wednesday, April 26, 1995 / Notices DEPARMENT OF THE TREASURY Services, U.S. Customs Service, 1301 TABLE 1.ÐPHARMACEUTICAL APPEN- Constitution Avenue NW, Washington, DIX TO THE HTSUSÐContinued Customs Service D.C. 20229 at (202) 927±1060. CAS No. Pharmaceutical [T.D. 95±33] Dated: April 14, 1995. 52±78±8 ..................... NORETHANDROLONE. A. W. Tennant, 52±86±8 ..................... HALOPERIDOL. Pharmaceutical Tables 1 and 3 of the Director, Office of Laboratories and Scientific 52±88±0 ..................... ATROPINE METHONITRATE. HTSUS 52±90±4 ..................... CYSTEINE. Services. 53±03±2 ..................... PREDNISONE. 53±06±5 ..................... CORTISONE. AGENCY: Customs Service, Department TABLE 1.ÐPHARMACEUTICAL 53±10±1 ..................... HYDROXYDIONE SODIUM SUCCI- of the Treasury. NATE. APPENDIX TO THE HTSUS 53±16±7 ..................... ESTRONE. ACTION: Listing of the products found in 53±18±9 ..................... BIETASERPINE. Table 1 and Table 3 of the CAS No. Pharmaceutical 53±19±0 ..................... MITOTANE. 53±31±6 ..................... MEDIBAZINE. Pharmaceutical Appendix to the N/A ............................. ACTAGARDIN. 53±33±8 ..................... PARAMETHASONE. Harmonized Tariff Schedule of the N/A ............................. ARDACIN. 53±34±9 ..................... FLUPREDNISOLONE. N/A ............................. BICIROMAB. 53±39±4 ..................... OXANDROLONE. United States of America in Chemical N/A ............................. CELUCLORAL. 53±43±0
    [Show full text]
  • Ep 1462107 A1
    Europäisches Patentamt *EP001462107A1* (19) European Patent Office Office européen des brevets (11) EP 1 462 107 A1 (12) EUROPEAN PATENT APPLICATION (43) Date of publication: (51) Int Cl.7: A61K 31/565, A61K 31/57, 29.09.2004 Bulletin 2004/40 A61P 15/18 (21) Application number: 03075905.4 (22) Date of filing: 28.03.2003 (84) Designated Contracting States: (72) Inventors: AT BE BG CH CY CZ DE DK EE ES FI FR GB GR • Coelingh Bennink, Herman Jan Tijmen HU IE IT LI LU MC NL PT RO SE SI SK TR 3971 BE Driebergen (NL) Designated Extension States: • Visser, Monique AL LT LV MK 3704 BB Zeits (NL) (71) Applicant: Pantarhei Bioscience B.V. (74) Representative: Jorritsma, Ruurd 3701 CH Zeist (NL) Nederlandsch Octrooibureau Postbus 29720 2502 LS Den Haag (NL) (54) Method of female contraception and kit for use in such method (57) The present invention is concerned with a dydrogesterone. method of contraception in a female mammal of child- Another aspect of the invention relates to a kit com- bearing capability, said method comprising orally ad- prising a plurality of oral dosage units, said plurality of ministering to the female a combination of estrogen and daily hormone units containing an estrogen in an progestogen continuously for at least 3 months, wherein amount equivalent to 2.2-5 mg 17β-estradiol and a pro- the estrogen is selected from the group consisting of gestogen in an amount equivalent to 5-50 mg dydroges- 17β-estradiol, precursors of 17β-estradiol and combina- terone, wherein the estrogen is selected from the group tions thereof, said estrogen being administered in an consisting of 17β-estradiol, precursors of 17β-estradiol amount equivalent to a daily oral dosage of 2.2-5 mg and combinations thereof.
    [Show full text]
  • Annex 2. Preparations of Oestrogens, Progestogens and Combinations of Oestrogens and Progestogens That Are Or Have Been Used As
    Annex 2. Preparations of oestrogens, progestogens and combinations of oestrogens and progestogens that are or have been used as hormonal contraceptives and for post-menopausal hormonal therapy, with known trade names Table 1. Some combinations of oestrogens and progestogens used in oral contraceptives, with known trade names Combination Trade names Oestrogen Dose Progestogen Dose (μg) (mg) Ethinyloestradiol Biphasic 50 Chlormadinone acetate 1/2 Neo-Eunomin Monophasic 35 Cyproterone acetate 2 Diane, Diane-35, Diane-Mite, Diane Nova, Dianette, Gynofen 35 Monophasic 20 Desogestrel 0.15 Cycléane-20, Lovelle, Marvelon 20, Mercilon, Microdosis, Myralon, Securgin, Segurin ANNEX 2 Monophasic 30 Desogestrel 0.15 Cycléane-30, Desogen, Desolett, Frilavon, Marvelon, Marvelon 30, Marviol, Microdiol, Novelon, Ortho-Cept, Planum, Practil, Prevenon, Varnoline Biphasic 40/30 Desogestrel 0.025/0.125 Gracial Biphasic 50 Desogestrel 0/0.125 Ovidol, Oviol Triphasic 35/30 Desogestrel 0.05/0.1/0.15 Trimiron Monophasic 30 Dienogest 2 Valette Monophasic 20 Gestodene 0.075 Harmonet, Meliane Monophasic 30 Gestodene 0.075 Ciclomex, Evacin, Femodeen, Femoden, Femodene, Femovan, Ginera, Ginoden, Gynera, Gynovin, Minulet, Minulette, Moneva, Myvlar Triphasic 30/40/30 Gestodene 0.05/0.07/0.1 Milvane, Phaeva, Triadene, Tricilomex, Tri- Femoden, Trigynera, Tri-Gynera, Trigynovin, Triminulet, Triodeen, Trioden, Triodena, Triodene Monophasic 20 Levonorgestrel 0.1 Miranova Minisiston, Monostep Monophasic 30 Levonorgestrel 0.125 615 616 Table 1 (contd) Combination Trade names
    [Show full text]
  • Controlled Release Systems and Low
    E-™ llll INI II llll III III I II II II I II � European Patent Office Office europeen des brevets (1 1 ) EP0 591 311 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) |nt. CI.6: A61 K 9/16, A61 K 31/57 of the grant of the patent: 17.12.1997 Bulletin 1997/51 (86) International application number: PCT/CA92/00275 (21) Application number: 92912973.2 (87) International publication number: (22) Date of filing: 26.06.1992 WO 93/00070 (07.01.1993 Gazette 1 993/02) (54) CONTROLLED RELEASE SYSTEMS AND LOW DOSE ANDROGENS SYSTEME MIT GESTEUERTER FREIGABE UND NIEDRIGDOSIERTE ANDROGENE ANDROGENES DE FAIBLE DOSAGE ET SYSTEMES A LIBERATION REGULEE (84) Designated Contracting States: (74) Representative: AT BE CH DE DK ES FR GB GR IT LI LU MC NL Ablewhite, Alan James et al SE MARKS & CLERK, 57/60 Lincoln's Inn Fields (30) Priority: 28.06.1991 US 724532 London WC2A 3LS (GB) 24.06.1992 US 900817 (56) References cited: (43) Date of publication of application: EP-A- 0 058 481 WO-A-89/03678 13.04.1994 Bulletin 1994/15 WO-A-90/1 0462 DE-A-4 036 425 (73) Proprietor: ENDORECHERCHE INC. • CHEMICAL ABSTRACTS, vol. 97, no. 4, 26 July Quebec, Quebec G1 W 2 J6 (CA) 1 982, Columbus, Ohio, US; abstract • no. 28542e, LU, BIN 'studies on the injection of (72) Inventors: microencapsulated compound megestrol • LABRIE, Fernand acetate' page 306 jcolumn 2 ; Quebec, Quebec G1 W 2J6 (CA) . 'the merck index' 1989 j MERCK & CO., INC , • LEPAGE, Martin RAHWAY, N.J.
    [Show full text]
  • Supplement Template Portrait Using Blank Overlay Word 2010
    PASS information Title Drug utilization study of cyproterone/ethinylestradiol (Diane®- 35 and generics) in the Netherlands, UK and Italy Protocol version identifier Version 4.0 Date of last version of protocol 5 September 2014 EU PAS register number Study not yet registered Active substance Cyproterone/ethinylestradiol (CPA/EE), ATC code G03HB01, anti-androgens and oestrogens Medicinal product Diane®-35 and its generics Product reference Reference number(s) of centrally authorised products and/or, if possible, of nationally authorised products subject to the study Procedure number Referral: EMEA/H/A-107i/1357 Marketing authorization holder(s) Bayer Pharma AG on behalf of a group of MAHs Joint PASS Yes The study objectives are to characterize new users of CPA/EE in Research question and objectives 2011/2012 and in 2014 according to demographics, treatment characteristics, previous diagnosis of acne, hirsutism or other hyperandrogenic conditions, previous acne treatment and (concomitant) use of hormonal contraceptives. A secondary objective is to compare patient and treatment characteristics between January 1, 2011 and December 31, 2012 and January 1, 2014 and December 31, 2014. Country(-ies) of study The Netherlands, United Kingdom, Italy Irene Bezemer, PhD, International Research Program Manager Author Eline Houben, MSc, Researcher Fernie Penning – van Beest, PhD, Senior Research Quality Manager PHARMO Institute for Drug Outcomes Research Van Deventerlaan 30-40 3528 AE Utrecht, the Netherlands +31 (0)30 7440 800 [email protected] Page 1 of 51 Marketing authorization holder Marketing authorization holder(s) Bayer Pharma AG MAH contact person Mary Elizabeth Murphy Global Regulatory Affairs Bayer Pharma AG Müllerstrasse 178, 13353 Berlin, Germany The study will be conducted in compliance with the protocol and any applicable regulatory requirements.
    [Show full text]
  • Stembook 2018.Pdf
    The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances FORMER DOCUMENT NUMBER: WHO/PHARM S/NOM 15 WHO/EMP/RHT/TSN/2018.1 © World Health Organization 2018 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation. The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances. Geneva: World Health Organization; 2018 (WHO/EMP/RHT/TSN/2018.1). Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data.
    [Show full text]
  • Oral Contraceptives for Pain Associated with Endometriosis (Review)
    Cochrane Database of Systematic Reviews Oral contraceptives for pain associated with endometriosis (Review) Brown J, Crawford TJ, Datta S, Prentice A Brown J, Crawford TJ, Datta S, Prentice A. Oral contraceptives for pain associated with endometriosis. Cochrane Database of Systematic Reviews 2018, Issue 5. Art. No.: CD001019. DOI: 10.1002/14651858.CD001019.pub3. www.cochranelibrary.com Oral contraceptives for pain associated with endometriosis (Review) Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. TABLE OF CONTENTS HEADER....................................... 1 ABSTRACT ...................................... 1 PLAINLANGUAGESUMMARY . 2 SUMMARY OF FINDINGS FOR THE MAIN COMPARISON . ..... 4 BACKGROUND .................................... 6 OBJECTIVES ..................................... 6 METHODS ...................................... 6 RESULTS....................................... 9 Figure1. ..................................... 10 Figure2. ..................................... 12 Figure3. ..................................... 13 Figure4. ..................................... 15 Figure5. ..................................... 17 Figure6. ..................................... 18 Figure7. ..................................... 19 ADDITIONALSUMMARYOFFINDINGS . 20 DISCUSSION ..................................... 23 AUTHORS’CONCLUSIONS . 24 ACKNOWLEDGEMENTS . 24 REFERENCES ..................................... 24 CHARACTERISTICSOFSTUDIES . 27 DATAANDANALYSES. 38 Analysis 1.1. Comparison 1 Combined oral contractive
    [Show full text]
  • Customs Tariff - Schedule
    CUSTOMS TARIFF - SCHEDULE 99 - i Chapter 99 SPECIAL CLASSIFICATION PROVISIONS - COMMERCIAL Notes. 1. The provisions of this Chapter are not subject to the rule of specificity in General Interpretative Rule 3 (a). 2. Goods which may be classified under the provisions of Chapter 99, if also eligible for classification under the provisions of Chapter 98, shall be classified in Chapter 98. 3. Goods may be classified under a tariff item in this Chapter and be entitled to the Most-Favoured-Nation Tariff or a preferential tariff rate of customs duty under this Chapter that applies to those goods according to the tariff treatment applicable to their country of origin only after classification under a tariff item in Chapters 1 to 97 has been determined and the conditions of any Chapter 99 provision and any applicable regulations or orders in relation thereto have been met. 4. The words and expressions used in this Chapter have the same meaning as in Chapters 1 to 97. Issued January 1, 2018 99 - 1 CUSTOMS TARIFF - SCHEDULE Tariff Unit of MFN Applicable SS Description of Goods Item Meas. Tariff Preferential Tariffs 9901.00.00 Articles and materials for use in the manufacture or repair of the Free CCCT, LDCT, GPT, UST, following to be employed in commercial fishing or the commercial MT, MUST, CIAT, CT, harvesting of marine plants: CRT, IT, NT, SLT, PT, COLT, JT, PAT, HNT, Artificial bait; KRT, CEUT, UAT, CPTPT: Free Carapace measures; Cordage, fishing lines (including marlines), rope and twine, of a circumference not exceeding 38 mm; Devices for keeping nets open; Fish hooks; Fishing nets and netting; Jiggers; Line floats; Lobster traps; Lures; Marker buoys of any material excluding wood; Net floats; Scallop drag nets; Spat collectors and collector holders; Swivels.
    [Show full text]