| OPPOSITION | - Anonymous, "ANNEX I - LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, APPLICANT(S) MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES - Daivobet®", EMA, (20110401), XP093262754 | - |
| OPPOSITION | - Anonymous, "Calcipotriene and Betamethasone Dipropionate (ENSTILAR) Foam 0.005% / 0.064%", National Drug Monograph, VA Pharmacy Benefits Management Services, Medical Advisory Panel, and VISN Pharmacist Executives, National Drug Monograph, VA Pharmacy Benefits Management Services, Medical Advisory Panel, and VISN Pharmacist Executives, URL: https://www.pbm.va.gov/clinicalguidance/drugmonographs/Calcipotriene_Betamethasone_Dipropionate_Foam_ENSTILAR_Monograph.pdf, XP093262645 | - |
| OPPOSITION | - Anonymous, "CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 207589Orig1s000 - Enstilar Foam Calcipotriene and betamethasone dipropionate Foam, 0.005%/0.064%", FDA, CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S), (20141201), XP093262639 | - |
| OPPOSITION | - Anonymous, "Clinical trial results: LEO 90100 twice weekly maintenance regimen for psoriasis vulgaris", (8&OLQLFDO7ULDOV5HJLVWHU, (8&OLQLFDO7ULDOV5HJLVWHU, URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-000556-95/results, XP093262588 | - |
| OPPOSITION | - Anonymous, "Enstilar 50 micrograms/g + 0.5 mg/g cutaneous foam - Summary of Product Characteristics", medicines.org.uk, medicines.org.uk, URL: https://www.medicines.org.uk/emc/product/2139/smpc/print, XP093262692 | - |
| OPPOSITION | - Anonymous, "Enstilar - Final Public Assessment Report - Scientific discussion", pages 1 - 18, URL: https://mri.cts-mrp.eu/human/downloads/DK_H_2478_001_PAR.pdf, (20201118), XP055752029 | - |
| OPPOSITION | - Anonymous, "HIGHLIGHTS OF PRESCRIBING INFORMATION - ENSTILAR ® Foam", FDA, FDA, URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207589s000lbl.pdf, XP093262616 | - |
| OPPOSITION | - Anonymous, "LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris - NCT02899962", Clinical Trials, ClinicalTrials.gov, Clinical Trials, URL: https://clinicaltrials.gov/study/NCT02899962?term=NCT02899962&rank=1&tab=history&a=26#version-content-panel, XP093262655 | - |
| OPPOSITION | - Anonymous, "LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris - NCT02899962", Clinical Trials, ClinicalTrials.gov, Clinical Trials, URL: https://clinicaltrials.gov/study/NCT02899962?term=NCT02899962&rank=1&tab=history&a=27#version-content-panel, XP093262654 | - |
| OPPOSITION | - Anonymous, "LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris - NCT02899962", Clinical Trials, ClinicalTrials.gov, Clinical Trials, URL: https://clinicaltrials.gov/study/NCT02899962?term=NCT02899962&rank=1&tab=history&a=35#version-content-panel, XP093262605 | - |
| OPPOSITION | - Anonymous, "Xamiol® - Gebrauchsinformation: Information für den Anwender", LEO Pharma A/S, (20100301), XP093262610 | - |
| OPPOSITION | - Lindstrom Jill A., "Enstilar 207589Orig1s000 SUMMARY REVIEW", Summary Review for Regulatory Action, CENTER FOR DRUG EVALUATION AND RESEARCH, pages 1 - 11, Summary Review for Regulatory Action , URL: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207589Orig1s000SumR.pdf, XP093263642 | - |
| OPPOSITION | - PUBCHEM COMPOUND, (20101222), XP093262675 | - |
| OPPOSITION | - PUBCHEM COMPOUND, (20180117), XP093262683 | - |
| OPPOSITION | - Segaert Siegfried, Shear Neil H., Chiricozzi Andrea, Thaçi Diamant, Carrascosa Jose-Manuel, Young Helen, Descamps Vincent, "Optimizing Anti-Inflammatory and Immunomodulatory Effects of Corticosteroid and Vitamin D Analogue Fixed-Dose Combination Therapy", Dermatology and Therapy, (20170901), vol. 7, no. 3, doi:10.1007/s13555-017-0196-z, ISSN 2193-8210, pages 265 - 279, XP093262619 | |
| OPPOSITION | - Queille-Roussel Catherine, Olesen Martin, Villumsen John, Lacour Jean-Philippe, "Efficacy of an Innovative Aerosol Foam Formulation of Fixed Combination Calcipotriol plus Betamethasone Dipropionate in Patients with Psoriasis Vulgaris", Clinical Drug Investigation, ADIS INTERNATIONAL, AUCKLAND., NZ, NZ , (20150401), vol. 35, no. 4, doi:10.1007/s40261-015-0269-7, ISSN 1173-2563, pages 239 - 245, XP093262632 | |
| OPPOSITION | - Lebwohl Mark; Kircik Leon; Lacour Jean-Philippe; Liljedahl Monika; Lynde Charles; Mørch Marie Holst; Papp Kim A.; Perrot Jean-Luc; Gold Linda Stein; Takhar Amrit; Thaçi Diamant; Warren Richard B.; Wollenberg Andreas, "Twice-weekly topical calcipotriene/betamethasone dipropionate foam as proactive management of plaque psoriasis increases time in remission and is well tolerated over 52 weeks (PSO-LONG trial)", Journal of the American Academy of Dermatology, Mosby, Inc, US, US , (20200918), vol. 84, no. 5, doi:10.1016/j.jaad.2020.09.037, ISSN 0190-9622, pages 1269 - 1277, XP086532821 | |
| OPPOSITION | - Imafuku Shinichi, Zheng Min, Tada Yayoi, Zhang Xibao, Theng Colin, Thevarajah Suganthi, Zhao Yi, Song Hae Jun, "Asian consensus on assessment and management of mild to moderate plaque psoriasis with topical therapy", Journal of dermatology, JAPANESE DERMATOLOGICAL ASSOCIATION, TOKYO., JP, JP , (20180701), vol. 45, no. 7, doi:10.1111/1346-8138.14338, ISSN 0385-2407, pages 805 - 811, XP093262565 | |
| OPPOSITION | - Augustin Matthias, Mrowietz Ulrich, Bonnekoh Bernd, Rosenbach Thomas, Thaçi Diamant, Reusch Michael, Ardabili Michael, Reich Kristian, "Topical long‐term therapy of psoriasis with vitamin D 3 analogues, corticosteroids and their two compound formulations: position paper on evidence and use in daily practice", JDDG. JOURNAL DER DEUTSCHEN DERMATOLOGISCHEN GESELLSCHAFT, BLACKWELL VERLAG, BERLIN, DE, DE , (20140801), vol. 12, no. 8, doi:10.1111/ddg.12396, ISSN 1610-0379, pages 667 - 682, XP093262558 | |
| OPPOSITION | - K. Kragballe; J. Austad; L. Barnes; A. Bibby; M. De La Brassinne; F. Cambazard; C. Fleming; H. Heikkilä; D. Jolliffe; J. Peyri; Å. Svensson; J. Toole; G. Wozel, "A 52‐week randomized safety study of a calcipotriol/betamethasone dipropionate two‐compound product (Dovobet®/Daivobet®/Taclonex®) in the treatment of psoriasis vulgaris", British journal of dermatology (1951), Wiley, (20060324), vol. 154, no. 6, doi:10.1111/j.1365-2133.2006.07236.x, ISSN 0007-0963, pages 1155 - 1160, XP071145655 | |
| OPPOSITION | - Paul C., Stein Gold L., Cambazard F., Kalb R.E., Lowson D., Bang B., Griffiths C.E.M., "Calcipotriol plus betamethasone dipropionate aerosol foam provides superior efficacy vs. gel in patients with psoriasis vulgaris: randomized, controlled PSO‐ABLE study", JEADV , The Journal of the European Academy of Dermatology and Venereology, ELSEVIER SCIENCE PUBLISHERS, AMSTERDAM., NL, NL , (20170101), vol. 31, no. 1, doi:10.1111/jdv.13859, ISSN 0926-9959, pages 119 - 126, XP093262575 | |
| OPPOSITION | - J.-H. Lee, C.-J. Park, T.-Y. Kim, Y.-B. Choe, N.-I. Kim, H.-J. Song, J.-I. Youn, S.-W. Youn, J.-H. Choi, K.-J. Kim, "Optimal maintenance treatment with calcipotriol/betamethasone dipropionate gel in Korean patients with psoriasis vulgaris: a multicentre randomized, controlled clinical trial", JEADV , The Journal of the European Academy of Dermatology and Venereology, ELSEVIER SCIENCE PUBLISHERS, AMSTERDAM., NL, NL , (20170301), vol. 31, no. 3, doi:10.1111/jdv.13865, ISSN 0926-9959, pages 483 - 489, XP055751625 | |
| OPPOSITION | - Luger T.A., Cambazard F., Larsen F.G., Bourcier M., Gupta G., Clonier F., Kidson P., Shear N.H., "A Study of the Safety and Efficacy of Calcipotriol and Betamethasone Dipropionate Scalp Formulation in the Long-Term Management of Scalp Psoriasis", DERMATOLOGY, S. Karger AG, CH, CH , (20080101), vol. 217, no. 4, doi:10.1159/000155642, ISSN 1018-8665, pages 321 - 328, XP009560218 | |
| OPPOSITION | - Liu Xiaofang, Yang Guang, Luo Mengxin, Lan Qi, Shi Xiaoxia, Deng Haoyuan, Wang Ningning, Xu Xuezhu, Zhang Cong, "Serum vitamin E levels and chronic inflammatory skin diseases: A systematic review and meta-analysis", PLOS ONE, Public Library of Science, US, US , vol. 16, no. 12, doi:10.1371/journal.pone.0261259, ISSN 1932-6203, page e0261259, XP093262669 | |
| OPPOSITION | - Zhu Hong, Wu Yan, He Chun-Di, Chen Hong-Duo , "New Treatment Regimen with Calcipotriol/ Betamethasone Ointment on Psoriasis Vulgaris of Stationary Stage", Clin. Pediatr. Dermatol., (20160210), vol. 2, no. 1, doi:10.21767/2472-0143.100011, ISSN 2472-0143, pages 1 - 5, XP093262557 | |
| OPPOSITION | - Girolomoni Giampiero, Calzavara Pinton Piergiacomo, Cristaudo Antonio, Cicchetti Americo, "Back to the future: a new topical approach for mild-to-moderate psoriasis", Italian Journal of Dermatology and Venereology, Edizioni Minerva Medica, Italy, Italy, (20180601), vol. 153, no. 3, doi:10.23736/S0392-0488.16.05516-4, ISSN 2784-8671, pages 375 - 382, XP093262568 | |
| OPPOSITION | - Saraceno Rosita, Camplone Germana, D'agostino Magda, De Simone Clara, Di Cesare Antonella, Filosa Giorgio, Frascione Pasquale, Gabellini Massimo, Lunghi Franco, Mazzotta Annamaria, Peris Ketty, Scotto Di Luzio Genoveffa, Calvieri Stefano, Simonacci Marco, Chimenti Sergio, "Efficacy and maintenance strategies of two-compound formulation calcipotriol and betamethasone dipropionate gel (Xamiol® gel) in the treatment of scalp psoriasis: results from a study in 885 patients", The Journal of Dermatological Treatment, Informa Healthcare, UK, UK , (20130523), vol. 25, no. 1, doi:10.3109/09546634.2013.800182, ISSN 0954-6634, pages 30 - 33, XP009560219 | |
| OPPOSITION | - Koo John, Tyring Stephen, Werschler William P., Bruce Suzanne, Olesen Martin, Villumsen John, Bagel Jerry, "Superior efficacy of calcipotriene and betamethasone dipropionate aerosol foam versus ointment in patients with psoriasis vulgaris - A randomized phase II study", The Journal of Dermatological Treatment, Informa Healthcare, UK, UK , (20160303), vol. 27, no. 2, doi:10.3109/09546634.2015.1083935, ISSN 0954-6634, pages 120 - 127, XP093262570 | |
| OPPOSITION | - Pujari Vijay Kumar, "The Serum Levels of Malondialdehyde, Vitamin E and Erythrocyte Catalase Activity in Psoriasis Patients", JOURNAL OF CLINICAL AND DIAGNOSTIC RESEARCH, doi:10.7860/JCDR/2014/10912.5085, ISSN 2249-782X, XP093262660 | |
