ATC-Index Mit DDD-Angaben Für Deutschland Im Jahr 2020
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(201 1.01) A61k 31/713
( (51) International Patent Classification: S McAllister Ave., Tempe, Arizona 85281 (US). ZHANG, C12N 15/11 7 (20 10.01) B82Y 5/00 (201 1.01) Fei; 5460 S Scott PI, Chandler, Arizona 85249 (US). A61K 31/713 (2006.01) C12N 15/115 (2010.01) (74) Agent: NORTON, Vicki G.; DUANE MORRIS LLP, 750 A61K 39/39 (2006.01) B Street, Suite 2900, San Diego, California 92101-4681 (21) International Application Number: (US). PCT/U S201 9/013 118 (81) Designated States (unless otherwise indicated, for every (22) International Filing Date: kind of national protection av ailable) . AE, AG, AL, AM, 10 January 2019 (10.01.2019) AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, (25) Filing Language: English DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, (26) Publication Language: English HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, (30) Priority Data: MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, 62/615,806 10 January 2018 (10.01.2018) US OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, (71) Applicant: ARIZONA BOARD OF REGENTS ON BE¬ SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, HALF OF ARIZONA STATE UNIVERSITY [US/US]; TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. 1475 North Scottsdale Road, SkySong - Suite 200, Scotts¬ (84) Designated States (unless otherwise indicated, for every dale, Arizona 85257-3538 (US). -
Antiseptics and Disinfectants for the Treatment Of
Verstraelen et al. BMC Infectious Diseases 2012, 12:148 http://www.biomedcentral.com/1471-2334/12/148 RESEARCH ARTICLE Open Access Antiseptics and disinfectants for the treatment of bacterial vaginosis: A systematic review Hans Verstraelen1*, Rita Verhelst2, Kristien Roelens1 and Marleen Temmerman1,2 Abstract Background: The study objective was to assess the available data on efficacy and tolerability of antiseptics and disinfectants in treating bacterial vaginosis (BV). Methods: A systematic search was conducted by consulting PubMed (1966-2010), CINAHL (1982-2010), IPA (1970- 2010), and the Cochrane CENTRAL databases. Clinical trials were searched for by the generic names of all antiseptics and disinfectants listed in the Anatomical Therapeutic Chemical (ATC) Classification System under the code D08A. Clinical trials were considered eligible if the efficacy of antiseptics and disinfectants in the treatment of BV was assessed in comparison to placebo or standard antibiotic treatment with metronidazole or clindamycin and if diagnosis of BV relied on standard criteria such as Amsel’s and Nugent’s criteria. Results: A total of 262 articles were found, of which 15 reports on clinical trials were assessed. Of these, four randomised controlled trials (RCTs) were withheld from analysis. Reasons for exclusion were primarily the lack of standard criteria to diagnose BV or to assess cure, and control treatment not involving placebo or standard antibiotic treatment. Risk of bias for the included studies was assessed with the Cochrane Collaboration’s tool for assessing risk of bias. Three studies showed non-inferiority of chlorhexidine and polyhexamethylene biguanide compared to metronidazole or clindamycin. One RCT found that a single vaginal douche with hydrogen peroxide was slightly, though significantly less effective than a single oral dose of metronidazole. -
United States Atopic Dermatitis (AD) Market Report 2021
Source: Research and Markets July 28, 2021 04:08 ET United States Atopic Dermatitis (AD) Market Report 2021 Dublin, July 28, 2021 (GLOBE NEWSWIRE) -- The "Atopic Dermatitis (AD) - US Market Insight, Epidemiology and Market Forecast - 2030" report has been added to ResearchAndMarkets.com's offering. This 'Atopic Dermatitis (AD) - Market Insights, Epidemiology and Market Forecast- 2030' report delivers an in- depth understanding of the Atopic Dermatitis (AD), historical and forecasted epidemiology as well as the Atopic Dermatitis (AD) market trends in the United States. Key Findings The total prevalent population of AD in the United States was estimated to be 32,197,083 in 2020. The total diagnosed prevalent population of AD in the United States was estimated to be 25,091,967 in 2020. The prevalent population of AD in the United States is expected to increase at a CAGR of 0.58% during the study period 2018-2030. In the United States, the total number of adult cases of AD comprised of 5,684,566 males and 9,421,907 females in 2020. The total number of cases of mild AD were 9,065,394 in the United States, in 2020, as compared to the cases of moderate and severe AD with 4,365,771 and 1,661,712 cases respectively, in adults. In children, the total number of cases of mild AD were 6,690,281, in 2020, as compared to the cases of moderate and severe AD with 2,596,228 and 698,985 cases respectively, in the United States. Report Highlights In the coming years, Atopic Dermatitis (AD) market is set to change due to the rising awareness of the disease, and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market. -
Scientific Program Saturday, 17. July 2021 Factor VIII, Factor IX and Rare
Scientific programThe XXIX Congress of the International Society on Thrombosis and Haemostasis July 17-21, 2021 Philadelphia, U.S. Saturday, 17. July 2021 SSC Session 08:00 - 10:00 R1 Factor VIII, Factor IX and Rare Coagulation Disorders Introduction 08:00 - 08:02 Speaker: Johnny Mahlangu, ZA Non-Factor Replacement Therapies 08:02 - 08:02 Moderators: Johnny Mahlangu, South Africa, Tarek Owaidah, Saudi Arabia In Patients on Non-Factor Therapies, Exposure to Clotting 08:02 - 08:14 Factor Replacement Should Be Early (Debate) Speaker: Manuel Carcao, CA In Patients on Non-Factor Therapies, Exposure to Clotting 08:14 - 08:26 Factor Replacement Should Be Early (Debate) Speaker: Jayanthi Alamelu, GB Non-Factor Replacement Therapy Versus Factor Replacement 08:26 - 08:38 Therapy Risks -There Is No Free Lunch (Debate) Speaker: Bhavya Doshi, US Non-Factor Replacement Therapy Versus Factor Replacement 08:38 - 08:50 Therapy Risks -There Is No Free Lunch (Debate) Speaker: Gili Kenet, IL Beyond Annualized Bleed Rates What Should Be the Alternative 08:50 - 09:02 Endpoints for Non-Replacement Therapies Speaker: Alok Srivastava, IN Q&A Session 09:02 - 09:06 Gene Therapy 09:06 - 09:06 Moderators: Valder Arruda, United States, Savita Rangarajan, United Kingdom Anti Adeno-Associated Virus Antibodies Antibodies: What Are 09:06 - 09:18 the Standardization Issues? Speaker: David Lillicrap, CA Rationale for Adeno-associated Virus (AAV) Mediated Gene 09:24 - 09:30 Therapy in Patients With Anti Adeno-associated Virus Antibodies Speaker: David Cooper, NL What Should We Be Following-up Post Gene Therapy? 09:30 - 09:42 Speaker: Barbara A. -
Bebulin VH Corifact Factor VII Concentrate
P RODUCTS TO TREAT RARE FACTOR DEFICIENCIES Product Plasma source Fractionation Viral inactivation Vial size Storage Availability USA: volunteer, Vapour heat @ 60°C for 10 hr at Available through Special Bebulin VH remunerated Ion exchange 190 mbar, then 80°C for 1 hr @ 600 IUs 2‐8°C Access Programme. Manufactured by plasmapheresis adsorption 375 mbar Shire donors distributed in all provinces. Comments Factor IX complex containing factors II, VII, IX and X, heparin added. Product Plasma source Fractionation Viral inactivation Vial size Storage Availability Purification steps: 1) Precipitation/adsorption 250 IUs USA: volunteer, (4 mL of diluent) 2) Ion exchange chromatography Corifact remunerated Multiple Licensed by Health Canada. 1,250 IUs 2‐8°C Manufactured by plasmapheresis precipitation 3) Heat‐treatment (+60°C for 10 (20 mL of diluent) Distributed in all provinces. CSL Behring donors hours in an aqueous solution) 4) Virus filtration over two 20 nm Mix2Vial filters in series Comments Indicated for routine prophylaxis and peri‐operative management of surgical bleeding in patients with congenital factor XIII deficiency. Product Plasma source Fractionation Viral inactivation Vial size Storage Availability Factor VII USA: volunteer, Aluminium Vapour heat @ 60°C for 10 hr at Available through Special remunerated concentrate hydroxide 190 mbar, then 80°C for 1 hr @ 600 IUs 2‐8°C Access Programme. Manufactured by plasmapheresis adsorption 375 mbar Distributed in all provinces. Shire donors Comments Used to treat factor VII deficiency. 1 Product Plasma source Fractionation Viral inactivation Vial size Storage Availability Factor XI USA: volunteer, Affinity heparin Available through Special concentrate remunerated sepharose Dry heat @ 80°C, 72 hr 1,000 IUs 2‐8°C Access Programme. -
(CHMP) Agenda for the Meeting on 22-25 February 2021 Chair: Harald Enzmann – Vice-Chair: Bruno Sepodes
22 February 2021 EMA/CHMP/107904/2021 Human Medicines Division Committee for medicinal products for human use (CHMP) Agenda for the meeting on 22-25 February 2021 Chair: Harald Enzmann – Vice-Chair: Bruno Sepodes 22 February 2021, 09:00 – 19:30, room 1C 23 February 2021, 08:30 – 19:30, room 1C 24 February 2021, 08:30 – 19:30, room 1C 25 February 2021, 08:30 – 19:30, room 1C Disclaimers Some of the information contained in this agenda is considered commercially confidential or sensitive and therefore not disclosed. With regard to intended therapeutic indications or procedure scopes listed against products, it must be noted that these may not reflect the full wording proposed by applicants and may also vary during the course of the review. Additional details on some of these procedures will be published in the CHMP meeting highlights once the procedures are finalised and start of referrals will also be available. Of note, this agenda is a working document primarily designed for CHMP members and the work the Committee undertakes. Note on access to documents Some documents mentioned in the agenda cannot be released at present following a request for access to documents within the framework of Regulation (EC) No 1049/2001 as they are subject to on- going procedures for which a final decision has not yet been adopted. They will become public when adopted or considered public according to the principles stated in the Agency policy on access to documents (EMA/127362/2006). Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union © European Medicines Agency, 2021. -
Annex I Summary of Product Characteristics
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT NutropinAq 10 mg/2 ml (30 IU) solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One cartridge contains 10 mg (30 IU) of somatropin* * human growth hormone produced in Escherichia coli cells by recombinant DNA technology. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. NutropinAq is a solution for subcutaneous use. The clear, colourless, sterile solution for multidose use is contained in a glass cartridge, closed with a rubber stopper and a rubber seal. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications - Long-term treatment of children with growth failure due to inadequate endogenous growth hormone secretion. - Long-term treatment of growth failure associated with Turner syndrome. - Treatment of prepubertal children with growth failure associated with chronic renal insufficiency up to the time of renal transplantation. - Replacement of endogenous growth hormone in adults with growth hormone deficiency of either childhood or adult-onset etiology. Growth hormone deficiency should be confirmed appropriately prior to treatment (see section 4.4). 4.2 Posology and method of administration Diagnosis and therapy with somatropin should be initiated and monitored by physicians who are appropriately qualified and experienced in the diagnosis and management of patients with the therapeutic indication of use. The NutropinAq dosage and administration schedule should be individualised for each patient. Dosage Growth failure in children due to inadequate growth hormone secretion: 0.025 - 0.035 mg/kg bodyweight given as a daily subcutaneous injection. Somatropin therapy should be continued in children and adolescents until their epiphysis are closed. -
Suomen Lääketilasto 2019
SUOMEN LÄÄKETILASTO S LT FINNISH STATISTICS ON MEDICINES FSM 2019 Keskeisiä lukuja lääkkeiden myynnistä ja lääkekorvauksista vuonna 2019 Milj. € Muutos vuodesta 2018, % Lääkkeiden kokonaismyynti 3 460 5,2 avohoidon reseptilääkkeiden myynti (verollisin vähittäismyyntihinnoin) 2 284 4,4 avohoidon itsehoitolääkkeiden myynti (verollisin vähittäismyyntihinnoin) 357 0,8 sairaalamyynti (tukkuohjehinnoin) 818 9,9 Lääkkeistä maksetut korvaukset 1 551 6,2 peruskorvaukset 316 3,0 erityiskorvaukset 1 029 5,2 lisäkorvaukset 205 17,7 Key figures for medicine sales and their reimburssement in 2019 € million Change from 2018, % Total sales of pharmaceuticals 3,460 5.2 prescription medicines in outpatient care (at pharmacy prices with VAT) 2,284 4.4 OTC medicines in outpatient care (at pharmacy prices with VAT) 357 0.8 sales to hospitals (at wholesale prices) 818 9.9 Reimbursement of medicine costs 1,551 6.2 Basic Refunds 316 3.0 Special Refunds 1,029 5.2 Additional Refunds 205 17.7 Lähde: Fimean lääkemyyntirekisteri, Kelan sairausvakuutuskorvausten tilastointitiedosto. Source: Finnish Medicines Agency, Drug Sales Register; Register of Statistical Information on National Health Insurance General Benefit Payments. SUOMEN LÄÄKETILASTO FINNISH STATISTICS ON MEDICINES 2019 Lääkealan turvallisuus- ja kehittämiskeskus Fimea ja Kansaneläkelaitos Finnish Medicines Agency Fimea and Social Insurance Institution Helsinki 2020 LÄÄKEALAN TURVALLISUUS- KANSANELÄKELAITOS JA KEHITTÄMISKESKUS FIMEA FINNISH MEDICINES AGENCY FIMEA SOCIAL INSURANCE INSTITUTION Lääketurvallisuus Analytiikka- ja tilastoryhmä Pharmacovigilance Section for Analytics and Statistics Mannerheimintie 166 Nordenskiöldinkatu 12 P.O. Box 55 P.O. Box 450 FI-00034 Fimea FI-00056 Kela Finland Finland [email protected] [email protected] Puh. 029 522 3341 Puh. 020 634 11 Tel. +358 29 522 3341 Tel. -
Kongressjournal Wmw Wiener Medizinische Wochenschrift
W Band 8 / Heft 10 www.springer.at/wmw-skriptum ISSN Print 1613-3803 P. b. b. Verlagspostamt 1201 Wien Plus.Zeitung 07Z037513P SpringerMedizin.at/schwerpunkt/oegari-2011 10/11 skriptum Kongressjournal wmw Wiener Medizinische Wochenschrift 15. bis 17. September 2011, Wien Jahrestagung der Österreichischen Gesellschaft für Anästhesiologie, Reanimation und Intensivmedizin Austrian International Congress 2011 – AIC Wissenschaftliche Leitung: Prim. Univ.-Prof. Dr. Sibylle Kozek-Langenecker inhalt 10/11 Inhalt brief der herausgeberin Jahrestagung der 4 Willkommen in Wien! Österreichischen S. Kozek-Langenecker Gesellschaft für beiträge Anästhesiologie, 6 Sedierung durch Nicht-AnästhesistInnen Reanimation und Robert D. Fitzgerald, Wien Intensivmedizin 7 Gerinnungsmanagement bei traumatisch bedingter (ÖGARI) Massivblutung D. Fries, P. Innerhofer, P. Perger, M. Gütl, S. Heil, N. Hofmann, W. Kneifl, L. 15. bis 17. September Neuner, T. Pernerstorfer, G. Pfanner, H. Schöchl, B. Ziegler, C. Köblinger und 2011, Wien S. Kozek-Langenecker, ARGE für perioperative Gerinnung der ÖGARI 10 Erstversorgung von SHT W. Mauritz und A. Brazinova, Wien 11 Extrakorporaler Gasaustausch W. Oczenski und C. Hörmann, Wien–St. Pölten 16 „Coagulation Day 2010“: Thrombosemanagement beim kritisch Kranken E. Schaden, Wien 19 Koma: Differenzialdiagnose im Notfall Schloss Schönbrunn E. Schmutzhard, Innsbruck 20 Präklinische Intubation A. von Goedecke, Steyr 21 Perioperative Gerinnungsoptimierung P. Innerhofer, D. Fries und M. Mittermayr, Innsbruck 24 Ist Muskelrelaxation noch zeitgemäß? K. Khünl-Brady, Innsbruck 26 Impressum wmw skriptum © Springer-Verlag 10/2011 3 brief der herausgeberin Willkommen in Wien! Sehr geehrte Kolleginnen, sehr geehrte Kollegen! Kurzfristig wurde uns die Möglichkeit eröffnet, Beiträge vom diesjährigen Kongress der Österreichi- schen Gesellschaft für Anästhesiologie, Reanimation und Intensivmedizin (ÖGARI) mit diesem PRIM. -
Keeping up with FDA Drug Approvals: 60 New Drugs in 60 Minutes Elizabeth A
Keeping Up with FDA Drug Approvals: 60 New Drugs in 60 Minutes Elizabeth A. Shlom, PharmD, BCPS Senior Vice President & Director Clinical Pharmacy Program | Acurity, Inc. Privileged and Confidential April 10, 2019 Privileged and Confidential Program Objectives By the end of the presentation, the pharmacist or pharmacy technician participant will be able to: ▪ Identify orphan drugs and first-in-class medications approved by the FDA in 2018. ▪ List five new drugs and their indications. ▪ Identify the place in therapy for three novel monoclonal antibodies. ▪ Discuss at least two new medications that address public health concerns. Dr. Shlom does not have any conflicts of interest in regard to this presentation. Both trade names and generic names will be discussed throughout the presentation Privileged and Confidential 2018 NDA Approvals (NMEs/BLAs) ▪ Lutathera (lutetium Lu 177 dotatate) ▪ Braftovi (encorafenib) ▪ Vizimpro (dacomitinib) ▪ Biktarvy (bictegravir, emtricitabine, ▪ TPOXX (tecovirimat) ▪ Libtayo (cemiplimab-rwic) tenofovir, ▪ Tibsovo (ivosidenib) ▪ Seysara (sarecycline) alafenamide) ▪ Krintafel (tafenoquine) ▪ Nuzyra (omadacycline) ▪ Symdeko (tezacaftor, ivacaftor) ▪ Orilissa (elagolix sodium) ▪ Revcovi (elapegademase-lvir) ▪ Erleada (apalutamide) ▪ Omegaven (fish oil triglycerides) ▪ Tegsedi (inotersen) ▪ Trogarzo (ibalizumab-uiyk) ▪ Mulpleta (lusutrombopag) ▪ Talzenna (talazoparib) ▪ Ilumya (tildrakizumab-asmn) ▪ Poteligeo (mogamulizumab-kpkc) ▪ Xofluza (baloxavir marboxil) ▪ Tavalisse (fostamatinib disodium) ▪ Onpattro (patisiran) -
SGO-2020-Annual-Meet
Society of Gynecologic Oncology 2020 Annual Meeting on Women’s Cancer Abstracts for Oral Presentation Scientific Plenary I: Shaping the Future with Innovative Clinical Trials: A Clearer Vision Ahead in Gynecologic Cancer 1 - Scientific Plenary Sentinel lymph node biopsy versus lymphadenectomy for high-grade endometrial cancer staging (SENTOR trial): A prospective multicenter cohort study M.C. Cusimanoa, D. Vicusb, K. Pulmanc, M.Q. Bernardinid, S. Laframboised, T. Mayd, G. Bouchard-Fortierd, L. Hogend, L.T. Gienb, A.L. Covensb, R. Kupetse, B.A. Clarkea, M. Cesaric, M. Rouzbahmand, J. Mirkovicb, G. Turashvilid, M. Magantid, A. Ziad, G.E.V. Ened and S.E. Fergusond. aUniversity of Toronto, Toronto, ON, Canada, bSunnybrook Odette Cancer Centre, Toronto, ON, Canada, cTrillium Health Partners, Credit Valley Hospital/University of Toronto, Mississauga, ON, Canada, dPrincess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada, eSunnybrook Cancer Centre/University of Toronto, Toronto, ON, Canada Objective: It is unclear whether sentinel lymph node biopsy (SLNB) can replace complete lymphadenectomy in women with high-grade endometrial cancer (EC). We performed a prospective multicenter cohort study (the SENTOR trial) to evaluate the performance characteristics of SLNB using indocyanine green (ICG) in stage I high-grade EC (ClinicalTrials.gov ID: NCT01886066). Method: Patients with clinical stage I grade 2 endometrioid or high-grade EC (grade 3 endometrioid, serous, clear cell, carcinosarcoma, undifferentiated, or mixed tumors) undergoing laparoscopic or robotic surgery at 3 cancer centers in Toronto, Canada, were prospectively recruited for SLNB with ICG. After SLNB, high-grade EC patients underwent pelvic and paraaortic lymphadenectomy (PLND/PALND), and grade 2 endometrioid EC patients underwent PLND only. -
Inflarx N.V. 2020 Dutch Board Report
InflaRx N.V. Dutch statutory board report and financial statements for the financial year ended December 31, 2020 - 1 - TABLE OF CONTENTS 1 Introduction ............................................................................................................................... 4 1.1 Preparation ................................................................................................................................. 4 1.2 Forward-looking statements ...................................................................................................... 4 2* Risk factors ................................................................................................................................ 7 2.1 Summary of key risk factors ...................................................................................................... 7 2.2 Risk factors ................................................................................................................................ 7 2.2.1 Risks related to our financial position and need for additional capital. ..................................... 7 2.2.2 Risks related to the discovery, development and commercialization of our product candidates. ................................................................................................................................................... 9 2.2.3 Risks related to our dependence on third parties ..................................................................... 20 2.2.4 Risks related to our intellectual property ................................................................................