| INTERNATIONAL-SEARCH-REPORT | - MARJIE L. HARD ET AL, "Pharmacokinetic Profile of a 2-Month Dose Regimen of Aripiprazole Lauroxil: A Phase I Study and a Population Pharmacokinetic Model", CNS DRUGS, AUCKLAND, NZ, (20170608), vol. 31, no. 7, doi:10.1007/s40263-017-0447-7, ISSN 1172-7047, pages 617 - 624, XP055590498 [Y] 1-15 * abstract * * page 623, column 1, paragraph 1 * | |
| INTERNATIONAL-SEARCH-REPORT | - WANG X ET AL, "P.533 The two-injection start of aripiprazole once-monthly provides rapid attainment of therapeutic concentrations without the need for 14-day oral tablet supplementation", EUROPEAN NEUROPSYCHOPHARMACOLOGY, ELSEVIER SIENCE PUBLISHERS BV , AMSTERDAM, NL, vol. 40, doi:10.1016/J.EURONEURO.2020.09.388, ISSN 0924-977X, (20201101), (20201117), XP086353709 [XP] 1-15 * the whole document * | |
| INTERNATIONAL-SEARCH-REPORT | - MARJIE L. HARD ET AL, "Pharmacokinetic Evaluation of a 1-Day Treatment Initiation Option for Starting Long-Acting Aripiprazole Lauroxil for Schizophrenia :", JOURNAL OF CLINICAL PSYCHOPHARMACOLOGY., US, (20181001), vol. 38, no. 5, doi:10.1097/JCP.0000000000000921, ISSN 0271-0749, pages 435 - 441, XP055590436 [Y] 1-15 * abstract * | |
| INTERNATIONAL-SEARCH-REPORT | - LESLIE CITROME, "Aripiprazole long-acting injectable formulations for schizophrenia: aripiprazole monohydrate and aripiprazole lauroxil", EXPERT REVIEW OF CLINICAL PHARMACOLOGY 20141101 EXPERT REVIEWS LTD. GBR, UK, (20151219), vol. 9, no. 2, doi:10.1586/17512433.2016.1121809, ISSN 1751-2433, pages 169 - 186, XP055398416 [Y] 1-15 * page 169, column 1 * * page 170 * | |
| OPPOSITION | - Ahmad Samir, Roy Archna, Lewis Shaila Angela, "New-Generation Antipsychotics Long-Acting Injectable Formulations and Drug-Delivery Technologies", INTERNATIONAL JOURNAL OF SCIENTIFIC RESEARCH, (20151201), vol. 4, no. 12, ISSN 2277-8179, pages 367 - 372, XP093295437 | - |
| OPPOSITION | - Anonymous, "ABILIFY MAINTENA ® (aripiprazole) for extended-release injectable suspension, for intramuscular use - HIGHLIGHTS OF PRESCRIBING INFORMATION ", FDA, (20170701), FDA, URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202971s010lbl.pdf, XP093295434 | - |
| OPPOSITION | - Anonymous, "ABILIFY MAINTENA ® (aripiprazole) for extended-release injectable suspension, for intramuscular use - HIGHLIGHTS OF PRESCRIBING INFORMATION", FDA, (20200101), FDA, URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202971s013lbl.pdf, XP093295406 | - |
| OPPOSITION | - Anonymous, "ARISTADA® (aripiprazole lauroxil) extended-release injectable suspension, for intramuscular use - HIGHLIGHTS OF PRESCRIBING INFORMATION", FDA, (20170601), XP093295442 | - |
| OPPOSITION | - Anonymous, "ARISTADA ® (aripiprazole lauroxil) extended-release injectable suspension, for intramuscular use - HIGHLIGHTS OF PRESCRIBING INFORMATION ", FDA, (20181101), FDA, URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207533s013lbl.pdf, XP093295407 | - |
| OPPOSITION | - Anonymous, "ARISTADA INITIO™ (aripiprazole lauroxil) extended-release injectable suspension, for intramuscular use - HIGHLIGHTS OF PRESCRIBING INFORMATION ", FDA, (20180601), FDA, URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209830lbl.pdf, XP093295432 | - |
| OPPOSITION | - Anonymous, "Attachment 1: Product information for AusPAR Abilify Maintena Aripiprazole ", Australian Government, (20141125), XP093295404 | - |
| OPPOSITION | - Anonymous, "FDA Approves Deltoid Injection Site for Ability Maintena® (aripiprazole) for extended-release injectable suspension in the Treatment of Schizophrenia ", Press Release, (20150730), Press Release, URL: https://www.otsuka-us.com/discover/fda-approves-deltoid-injection-site-for-abilify-maintena-for-extended-release-injectable-suspension-in-the-treatment-of-schizophrenia#:~:text=%E2%80%93%20JULY%2030%2C%202015%20%E2%80%93%20Otsuka,deltoid%20muscle%20of%20the%20arm., XP093295413 | - |
| OPPOSITION | - Anonymous, "Health Canada Approves Otsuka and Lundbecks ABILIFY MAINTENA® (aripiprazole for prolonged release injectable suspension) Alternative Initiation Regimen", Lundbeck Press Release, (20210303), Lundbeck Press Release, URL: https://www.lundbeck.com/ca/en/media/health-canada-approves-otsuka-and-lundbecks-abilify-maintena-aripiprazole-for-prolonged-release-injectable-suspension-3mar21-english, XP093295433 | - |
| OPPOSITION | - Anonymous, "Injection (medicine) ", Wikipedia, (20200324), Wikipedia, URL: https://en.wikipedia.org/w/index.php?title=Injection_(medicine)&oldid=947168102, XP093295411 | - |
| OPPOSITION | - Anonymous, "Low dead space syringe", Wikipedia, (20190930), Wikipedia, URL: https://en.wikipedia.org/w/index.php?title=Low dead space syringe&oldid=918859393, XP093295428 | - |
| OPPOSITION | - Anonymous, "Population Pharmacokinetics - Guidance for Industry - DRAFT GUIDANCE", FDA, (20190701), XP093295405 | - |
| OPPOSITION | - Anonymous, "PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION - ABILIFY MAINTENA® - Aripiprazole for prolonged release injectable suspension", (20210302), URL: https://pdf.hres.ca/dpd_pm/00060200.PDF, XP093295444 | - |
| OPPOSITION | - D10a - ABILIFY MAINTENA ® : Type II variation assessment report, European Medicines Agency, 17 September 2020 | - |
| OPPOSITION | - D10b - ABILIFY MAINTENA ® : Printout from the Union Register of medicinal products for human use | - |
| OPPOSITION | - D10c - Decision C(2020) 7576 of the European Commission, 27 October 2020 | - |
| OPPOSITION | - D10d - Official Journal of the European Union 63 (2020), C 409 | - |
| OPPOSITION | - D10e - ABILIFY MAINTENA ® : EP AR - Summary for the public, European Medicines Agency, November 2020 | - |
| OPPOSITION | - D10 - European Medicines Agency, Abilify Maintena®, ANNEX 1, Summary of Product Characteristics, pages 1-22, published: 27 August 2018 | - |
| OPPOSITION | - D11 - FDA, Center for Drug Evaluation and Research, Aripiprazole IM Depot Formulation, Appl. No. 202971Orig1s000, Clinical Pharmacology and Biopharmaceutics Review(s), pages 1-75, published: February 28, 2013 | - |
| OPPOSITION | - D17 - Public Assessment Report of the European Medicines Agency for Abilify Maintena EMEA/H/C/002755/0000 | - |
| OPPOSITION | - D48 - Annexes I to III of Decision C(2019) 3387 of the European Commission, 29 April 2019 | - |
| OPPOSITION | - D54 - Excerpt Rote Liste 2019, Entry Number 71 091 | - |
| OPPOSITION | - D55 - Federal Register/ Vol. 84, No. 134/ Friday, July 12, 2019 | - |
| OPPOSITION | - Hopkins Una, Arias Claudia Y, "Large-volume IM injections: A review of best practices", Oncology Nurse Advisor, (20130201), pages 32 - 37, XP093295027 | - |
| OPPOSITION | - Hughes Michelle, " Long-Acting Injectable (LAI) Dosing Chart", PharmD, (20190101), XP093295415 | - |
| OPPOSITION | - Meyer Jonathan M., "Aripiprazole lauroxil nanocrystal suspension", Current Psychiatry, (20181101), vol. 17, no. 1, pages 34 - 40, XP093295016 | - |
| OPPOSITION | - Peter-Strickland Timothy, Arash Raoufinia, Anna-Greta Nylander, Ross A. Baker, Anna Eramo, Na Jin, Robert D. Mcquade, Peter Hertel, Frank Larsen, "W86 Deltoid Injection of Aripiprazole Once-Monthly in the Treatment of Schizophrenia", Abstract Book- Posters for the ASCP Annual Meeting on 22-25 June 2015, (20150622), XP093295412 | - |
| OPPOSITION | - Raedler Lisa A., "Aripiprazole Lauroxil (Aristada): Long- Acting Atypical Antipsychotic Injection Approved for the Treatment of Patients with Schizophrenia", American Health & Drug Benefits, (20160301), vol. 9, pages 40 - 43, XP093295033 | - |
| OPPOSITION | - Samir Mr, Shah J, Shah Paresh B, Patel Mukesh S, Patel Mukesh R, Shah Samir J, Shah Shri B M, "A REVIEW ON EXTENDED RELEASE DRUG DELIVERY SYSTEM AND MULTIPARTICULATE SYSTEM", World Journal of Pharmaceutical Research, (20150801), vol. 4, no. 8, ISSN 2277-7105, pages 724 - 747, XP093295048 | - |
| OPPOSITION | - Wang X., M. Harlin, Y. Wang, F. Larsen, A. Raoufinia, "P.533 The two-injection start of aripiprazole once-monthly provides rapid attainment of therapeutic concentrations without the need for 14-day oral tablet supplementation", European Neuropsychopharmacology, (20201101), vol. 40, no. 1, pages S299 - S300, XP093295061 | - |
| OPPOSITION | - Hard Marjie L.; Wehr Angela Y.; Sadler Brian M.; Mills Richard J.; von Moltke Lisa, "Population Pharmacokinetic Analysis and Model-Based Simulations of Aripiprazole for a 1-Day Initiation Regimen for the Long-Acting Antipsychotic Aripiprazole Lauroxil", EUROPEAN JOURNAL OF DRUG METABOLISM AND PHARMACOKINETICS., EDITIONS MEDECINE ET HYGIENE, CHENE-BOURG, CH, CH , (20180611), vol. 43, no. 4, doi:10.1007/s13318-018-0488-4, ISSN 0378-7966, pages 461 - 469, XP036545314 | |
| OPPOSITION | - Chiara Rapinesi, Georgios D. Kotzalidis, Lorenzo Mazzarini, Roberto Brugnoli, Stefano Ferracuti, Sergio De Filippis, Ilaria Cuomo, Gloria Giordano, Antonio Del Casale, Gloria Angeletti, Gabriele Sani & Paolo Girardi, "Long-Acting Injectable (LAI) Aripiprazole Frmulations in the Treatment of Schizophrenia and Bipolar Disorder:a Systematic Review", Clinical Drug Investigation, ADIS INTERNATIONAL, AUCKLAND., NZ, NZ , (20190531), vol. 39, no. 8, doi:10.1007/s40261-019-00801-9, ISSN 1173-2563, pages 713 - 735, XP009561988 | |
| OPPOSITION | - Marjie L. Hard, Richard J. Mills, Brian M. Sadler, Angela Y. Wehr, Peter J. Weiden, Lisa Von Moltke, "Pharmacokinetic Profile of a 2-Month Dose Regimen of Aripiprazole Lauroxil: A Phase I Study and a Population Pharmacokinetic Model", CNS DRUGS, ADIS INTERNATIONAL, AUCKLAND, NZ, AUCKLAND, NZ , (20170701), vol. 31, no. 7, doi:10.1007/s40263-017-0447-7, ISSN 1172-7047, pages 617 - 624, XP055590281 | |
| OPPOSITION | - Cai Qing; He Luying; Wang Silin; Chu Wei; Zhou Lingli; Pan Wenli; Zhang Lu; Jiang Shan; Ma Dangyang; Liang Xue; Gou Jingxin; Yin Tian; Zhang Yu; Tang Xing; He Haibing, "Process control and in vitro/in vivo evaluation of aripiprazole sustained-release microcrystals for intramuscular injection", European Journal of Pharmaceutical Sciences- Author Manuscript, Elsevier Amsterdam, NL, NL , (20181004), vol. 125, doi:10.1016/j.ejps.2018.09.017, ISSN 0928-0987, pages 193 - 204, XP085511406 | |
| OPPOSITION | - Guo Xueting; Zhang Maolian; Guo Yibin; Liu Hao; Yang Bing; Gou Jingxin; Yin Tian; Zhang Yu; He Haibing; Liu Dongchun; Tang Xing, "Impact of jet pulverization and wet milling techniques on properties of aripiprazole long-acting injection and absorption mechanism research in vivo", International Journal of Pharmaceutics, Elsevier, AMSTERDAM, NL, AMSTERDAM, NL, (20211115), vol. 612, doi:10.1016/j.ijpharm.2021.121300, ISSN 0378-5173, XP086908342 | |
| OPPOSITION | - Jonathan M. Meyer, "Converting Oral to Long-Acting Injectable Antipsychotics: A Guide for the Perplexed", CNC Spectrums, Cambridge University Press, (20171201), vol. 22, no. S1, doi:10.1017/S1092852917000840, ISSN 2165-6509, pages 14 - 28, XP009561986 | |
| OPPOSITION | - Jonathan Meyer, Jain Rakesh, Wehr Angela, Rege Bhaskar, Von Moltke Lisa, Weiden Peter J, "27 A New Method for Initiating Treatment with the Long-acting Antipsychotic Aripiprazole Lauroxil", CNS spectrums, United States, United States , doi:10.1017/S109285291900021X, (20190201), pages 188 - 189, CNS spectrums, URL: https://www.cambridge.org/core/services/aop-cambridge-core/content/view/613944FD56F7F0270930B381980FDD11/S109285291900021Xa.pdf/27_a_new_method_for_initiating_treatment_with_the_longacting_antipsychotic_aripiprazole_lauroxil.pdf, XP055590329 | |
| OPPOSITION | - Jain Rakesh, Meyer Jonathan, Wehr Angela, Rege Bhaskar, Von Moltke Lisa, Weiden Peter J., "Size matters: the importance of particle size in a newly developed injectable formulation for the treatment of schizophrenia", CNS SPECTRUMS, MBL COMMUNICATIONS, NEW YORK, NY, US, US , (20200601), vol. 25, no. 3, doi:10.1017/S1092852919000816, ISSN 1092-8529, pages 323 - 330, XP093039195 | |
| OPPOSITION | - Wang Yanlin, Wang Xiaofeng, Harlin Matt, Larsen Frank, Panni Moeen, Yildirim Murat, Madera Jessica, Arias Liz, Forbes Andy, Mustafa Nihal, Ruiz-White Inez, Raoufinia Arash, "An alternative start regimen with aripiprazole once-monthly in patients with schizophrenia: population pharmacokinetic analysis of a single-day, two-injection start with gluteal and/or deltoid intramuscular injection", Current Medical Research and Opinion, HANTS, GB, GB , (20211101), vol. 37, no. 11, doi:10.1080/03007995.2021.1965974, ISSN 0300-7995, pages 1961 - 1972, XP093295021 | |
| OPPOSITION | - Hebbrecht Kaat, Morrens Manuel, Neels Hugo, Roosens Laurence, Sabbe Bernard, "Pharmacokinetic evaluation of the aripiprazole (once-monthly) injection for the treatment of bipolar disorder", Expert Opinion on Drug Metabolism & Toxicology, Ashley Productions London, GB, GB , (20181001), vol. 14, no. 10, doi:10.1080/17425255.2018.1515911, ISSN 1742-5255, pages 999 - 1005, XP093295059 | |
| OPPOSITION | - Raoufinia Arash, Peters-Strickland Timothy, Nylander Anna-Greta, Baker Ross A., Eramo Anna, Jin Na, Bricmont Patricia, Repella Jennifer, Mcquade Robert D., Hertel Peter, Larsen Frank, "Aripiprazole Once-Monthly 400 mg: Comparison of Pharmacokinetics, Tolerability, and Safety of Deltoid Versus Gluteal Administration", INTERNATIONAL JOURNAL OF NEUROPSYCHOPHARMACOLOGY, Cambridge Univ. Press, Cambridge, Cambridge , (20170401), vol. 20, no. 4, doi:10.1093/ijnp/pyw116, ISSN 1461-1457, pages 295 - 304, XP093295037 | |
| OPPOSITION | - Marjie L. Hard, Angela Y. Wehr, Yangchun Du, Peter J. Weiden, David Walling, Lisa Von Moltke, "Pharmacokinetic Evaluation of a 1-Day Treatment Initiation Option for Starting Long-Acting Aripiprazole Lauroxil for Schizophrenia :", Relmada Therapeutics, (20181001), vol. 38, no. 5, doi:10.1097/JCP.0000000000000921, pages 435 - 441, XP055590436 | |
| OPPOSITION | - Jung‐Ryul Kim; Hyo‐Bum Seo; Joo‐Youn Cho; Do‐Hyung Kang; Yong Ku Kim; Won‐Myong Bahk; Kyung‐Sang Yu; Sang‐Goo Shin; Jun Soo Kwon; In‐Jin Jang, "Population pharmacokinetic modelling of aripiprazole and its active metabolite, dehydroaripiprazole, in psychiatric patients", British journal of clinical pharmacology, BLACKWELL SCIENTIFIC PUBL., GB, GB , (20080521), vol. 66, no. 6, doi:10.1111/j.1365-2125.2008.03223.x, ISSN 0306-5251, pages 802 - 810, XP071600029 | |
| OPPOSITION | - Brissos Sofia, Miguel Ruiz Veguilla, David Taylor, Vicent Balanzá-Martinez, "The role of long-acting injectable antipsychotics in schizophrenia:a critical appraisal", Therapeutic Advances in Psychopharmacology, (20140101), vol. 4, no. 5, doi:10.1177/2045125314540297Therapeutic, pages 198 - 219, XP093295040 | |
| OPPOSITION | - Hard Marjie L., Wehr Angela, Von Moltke Lisa, Du Yangchun, Farwick Sarah, Walling David P., Sonnenberg John, "Pharmacokinetics and safety of deltoid or gluteal injection of aripiprazole lauroxil NanoCrystal® Dispersion used for initiation of the long-acting antipsychotic aripiprazole lauroxil", Therapeutic Advances in Psychopharmacology, SAGE Publications, (20190701), vol. 9, doi:10.1177/2045125319859964, ISSN 2045-1253, page 2045125319859964, XP093295408 | |
| OPPOSITION | - Raoufinia Arash, Baker Ross A., Eramo Anna, Nylander Anna-Greta, Landsberg Wally, Kostic Dusan, Larsen Frank, "Initiation of aripiprazole once-monthly in patients with schizophrenia", Current Medical Research and Opinion, HANTS, GB, GB , (20150304), vol. 31, no. 3, doi:10.1185/03007995.2015.1006356, ISSN 0300-7995, pages 583 - 592, XP055817962 | |
| OPPOSITION | - Chue, Pierre and James Chue, "A review of aripiprazole long-acting injection", Current Medical Research and Opinion, HANTS, GB, GB , (20151229), vol. 32, no. 3, doi:10.1185/03007995.2015.1123145, ISSN 0300-7995, pages 441 - 452, XP009561994 | |
| OPPOSITION | - Nguyen Vy, Darville Nicolas, Vermeulen An, "Pharmacokinetics of Long-Acting Aqueous Nano-/Microsuspensions After Intramuscular Administration in Different Animal Species and Humans—a Review", AAPS JOURNAL, AMERICAN ASSOCIATION OF PHARMACEUTICAL SCIENTISTS, US, US , (20221201), vol. 25, no. 1, doi:10.1208/s12248-022-00771-5, ISSN 1550-7416, page 4, XP093295052 | |
| OPPOSITION | - Koue Toshiko, Kubo Masanori, Funaki Tomoo, Fukuda Tsuyoshi, Azuma Junichi, Takaai Mari, Kayano Yuichiro, Hashimoto Yukiya, "Nonlinear Mixed Effects Model Analysis of the Pharmacokinetics of Aripiprazole in Healthy Japanese Males", Biological & pharmaceutical bulletin, PHARMACEUTICAL SOCIETY OF JAPAN, TOKYO., JP, JP , (20071101), vol. 30, no. 11, doi:10.1248/bpb.30.2154, ISSN 0918-6158, pages 2154 - 2158, XP093295064 | |
| OPPOSITION | - Hiraoka Shogo, Uchida Shinya, Namiki Noriyuki, "Preparation and Characterization of High-Content Aripiprazole-Loaded Core-Shell Structure Microsphere for Long-Release Injectable Formulation", Chemical and Pharmaceutical Bulletin, Pharmaceutical Society of Japan, JP, JP , (20140101), vol. 62, no. 7, doi:10.1248/cpb.c14-00110, ISSN 0009-2363, pages 654 - 660, XP093295439 | |
| OPPOSITION | - Leslie Citrome, "Aripiprazole long-acting injectable formulations for schizophrenia: aripiprazole monohydrate and aripiprazole lauroxil", Expert Review of Clinical Pharmacology 20141101 Expert Reviews Ltd. gbr, Taylor & Francis, UK, UK , (20160229), vol. 9, no. 2, doi:10.1586/17512433.2016.1121809, ISSN 1751-2433, pages 169 - 186, XP055398416 | |
| OPPOSITION | - Salzman Phyllis, Raoufinia Arash, Legacy Susan, Such Pedro, Eramo Anna, "Plasma concentrations and dosing of 2 long-acting injectable formulations of aripiprazole", Neuropsychiatric Disease and Treatment, Dove Medical Press Limited, (20170101), vol. 13, doi:10.2147/NDT.S133433, ISSN 1178-2021, pages 1125 - 1129, XP093295410 | |
| OPPOSITION | - Megan J. Ehret, Davis Erica, Luttrell Sarah E., Clark Caroline, "Aripiprazole Lauroxil NanoCrystal ® Dispersion Technology (Aristada Initio ® )", CLINICAL SCHIZOPHRENIA & RELATED PSYCHOSES, Walsh Medical Media, LLC, US, US , (20180601), vol. 12, no. 2, doi:10.3371/CSRP.EHDA071918, ISSN 1935-1232, pages 92 - 96, XP055590482 | |
| OPPOSITION | - Rahnfeld Lisa, Luciani Paola, "Injectable Lipid-Based Depot Formulations: Where Do We Stand?", Pharmaceutics, MDPI AG, Switzerland, Switzerland, vol. 12, no. 6, doi:10.3390/pharmaceutics12060567, ISSN 1999-4923, page 567, XP093226370 | |
| OPPOSITION | - Bartova Lucie, Dold Markus, Praschak-Rieder Nicole, Naderi-Heiden Angela, Kasper Siegfried, "Ultra-High-Dose Long-Acting Injectable Aripiprazole in Chronic Refractory Schizophrenia: A Case Report", (20151028), vol. 5, no. 5, doi:10.4172/2161-0495.1000270, ISSN 2161-0495, XP093295430 | |
