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Obtaining Marketing Authorisation for Fish Veterinary Medicinal Products: getting products to market



DATE » 03.09.2012

AUTHORS » I. Radeloff, B. Vandaele and K. Hellmann

PUBLISHED » World Aquaculture Congress: AQUA 2012
Praha, Czech Republic.
2nd-5th September 2012
Oral Presentation


Publications  - 21.11.2024





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Hyo- Parasuis, Pfizer) in Sows Under German Fi ... 07.06.2012 | Poster, 22nd IPVS (9th-14th June 2012), Jeju, Korea Efficacy and Safety of Baytril Max 10% Injectable in the Treatment of Naturally Occurring Porcine Respiratory Disea ... 07.06.2012 | Poster SP0083, 22nd IPVS, 9th - 14th June 2012, Jeju, Korea Obtaining Marketing Authorisation for fish veterinary medicinal products: Getting products to market 07.06.2012 | Accepted oral presentation at the World Aquaculture Society Conference, Prague, Czech Republic, Abstract 806, 2nd to 6th of Septem ... 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Selection Criteria for Antimicrobial Treatment of Bovine Respiratory Disease (BRD) based on Target Pathogens to be ... 28.11.2011 | European Buiatrics Forum 2011, Marseille, 16-18 Nov. 2011, Proceedings: page 187 Dirofilariosis in dogs in the Czech Republic - occurrence, therapy, and prevention 27.10.2011 | Veterinarstvi 2011; 61: 578-581 Status quo and current challenges related to antimicrobial resistance: The Consultants View 16.09.2011 | Joint HMA/CVMP Interested Parties Meeting "Antimicrobial Resistance in Veterinary Medicine" 15-16 September 2011, EMA, London, Un ... Selection Criteria for the Antimicrobial Treatment of Bovine Respiratory Disease based on Target Pathogens 09.09.2011 | Congress of the European College of Bovine Health Management, Liige, Belgium, 7.-9. Sep. 2011. Poster, Proceedings, 107, page 60 Current View on the Availability of Antimicrobials in Buiatric 08.09.2011 | Oral Communication, 6th European Congress of Bovine Health Management, 7.-9. September 2011, Liege, Belgium Proceedings, 108, pag ... eSubmission Requirements for Veterinary Medicinal Products and Practical Solutions 07.09.2011 | "7th Annual Conference on Regulation of Veterinary Medicines in Europe", 7th/8th September 2011, Barcelona, Spain Field Evalutations of the Efficacy and Safety of Emodepside plus Toltrazuril (Procox(r) Oral Suspension for Dogs) a ... 08.08.2011 | Parasitol Res (2011) 09: 21-28 Behandlung von puerperaler Septikaemie und Toxaemie (MMA) bei Zuchtsauen mit biologischer Therapie im Vergleich zu ... 03.08.2011 | Tieraerztl. Umschau 66, 303-311 (2011) Evaluation of the Therapeutic and Preventive Efficacy of 2.5% Moxidectin/10% Imidacloprid (Advocate(r), Bayer Anima ... 26.07.2011 | Parasitol Res (2011) 109: S77-86 Aktuulnn Poznatky O Dirofilariize V Českk Republice; Vvskyt, Terapie, Prevence 26.07.2011 | Proceedings : of International Conference on Pets, Kooice, Slovak Republic, September 2011 Effectiveness of the Homeopathic Preparation Zeel Compared with Carprofen in Dogs with Osteoarthritis 29.12.2010 | Journal of the American Animal Hospital Association 2011, 47, Jan/Feb p. 12-20 Treatment of Urinary Tract Infections in sows associated with Eschericia coli 20.07.2010 | Poster and Proceedings at the IPVS, Vancouver, Canada 2 Tylosin (Aivlosin) water medication for control of procine proliferative enteropathy (PPE): a field trial carried o ... 20.07.2010 | 21. IPVS Congress, Vancouver Canada, 18. - 21. 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York, UK, 20th Nov. 2009 Potential Consequences of the current Discussions and Papers on the Development of new Classes of Antimicrobials 20.10.2009 | Informal Lunch of HMA/CVMP and AVC, EGGVP and IFAH-Europe the Swedish Presidency, 20th October 2009, Uppsala, Sweden Availability for Veterinary Medicines for Bees in the European Union 12.09.2009 | Poster Presentation, Apimondia 2009, Montpellier, France Rechtliche Voraussetzungen zur Initiierung pharmakologischer und klinischer Studien 10.09.2009 | Proceedings of the 19th Symposium of the German-Speaking Veterinary Pharmacologists and Toxicologists, Munich, Germany, 10 Sep 200 ... Efficacy and Safety of ProMeris Duo for the treatment of generalised demodicosis in dogs from Italy and Albania 13.08.2009 | Poster, Proceedings of the 22nd Conference of the WAAVP, Calgary, Canada, 2009 Efficacy and Safety of Imidacloprid 10%/Moxidectin1% and Emodepside 2.1%/Praziquantel 8.6 % Spot-On Formulations in ... 12.08.2009 | Poster, Proceedings of 22. 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Efficacy and Safety of ProMeris Duo for the treatment of generalized demodicosis in dogs from Italy and Albania 05.06.2009 | Presentation given at the International Symposium of Ectoparasites in Pets (ISEP), Toulouse, France, 5th June 2009 Prevalence of Serum Markers of Feline Chronic Kidney Disease for Quality of Life 13.03.2009 | In: Kleintiermedizin; 3, 2009 Page A24 Therapeutic and Metaphylactic Efficacy of Tulathromycin (DRAXXIN(r)) in Porcine Respiratory Disease in Europe Assoc ... 03.11.2008 | Tierärztliche Umschau / 2008, pages 6´5-620 Rickettsia felis in Fleas, Germany 29.10.2008 | Emerging Infectious Diseases, Vol. ´4 No. 8, Aug 2008 Experiences Testing Swine Farms for the Presence of Bacterial Pathogens and possible Consequences for the Proof of ... 26.08.2008 | Poster at the Fourth International Conference on Antimicrobial Agents in Veterinary Medicine (AAVM), Prague, Czech Republic, 24.-2 ... Experiences Collecting Anaerobic Veterinary Pathogens from Dogs and Testing MICs using Microdilution Technique 26.08.2008 | Poster at the Fourth International Conference on Antimicrobial Agents in Veterinary Medicine (AAVM), Prague, Czech Republic, 24.-2 ... Metaphylaktische Wirksamkeit von Tulathromycin bei Schweinen während eines Ausbruchs von Bronchopneumonie in Slowen ... 26.08.2008 | Tierärztliche Umschau, 63, No. 8, Pages 419-425 Experiences Testing Cattle Farms for the Presence of Bacterial Pathogens and possible Consequences for the Proof of ... 25.08.2008 | Oral Presentation at the Fourth International Conference on Antimicrobial Agents in Veterinary Medicine (AAVM), Prague, Czech Repu ... Efficacy of Promeris Duo Spot On in Dogs Artificially Infested with Ixodes Ricinus Ticks 17.08.2008 | Oral Presentation at the World Small Animal Veterinary Association (WSAVA) and FECAVA Conference, Dublin, Ireland Wirksamkeit von ProMeris Duo Spot-on bei artifiziell mit Ixodes ricinus infestierten Hunden 10.07.2008 | Oral Presentation, Scientific Meeting of the German Association of veterinary parasitology and parasitological diseases (DVG Paras ... Evaluation of Four Fluoroquinolone Treatment Regimens for Acute Bovine Mastitis 10.07.2008 | World Buiatrics Conference July 2008. Poster 368 Metaphylactic Efficacy of DRAXXIN administered to Pigs during an Outbreak of Respiratory Disease in Slovenia 30.06.2008 | 20th International Pig Veterinary Society Congress June 2008, Durban, South Africa: P08.051, Poster Proceedings page 495 Use of Tulathromycin (Draxxin Inj. Sol.) in the treatment and prevention in swine at risk of developing respiratory ... 30.06.2008 | 20th International Pig Veterinary Society Congress, June 2008, Durban, South Africa. P05.018 Poster Proceedings Page 375 Rickettsia felis in Fleas, France 29.04.2008 | Emerging Infectious Diseases, Vol. 14, No. 4, April 2008 Utilisation du Renalzin, un Noveau Complexeur de Phophate Intestinal, dans le Cadre du Syndrome de l'Insuffisance R ... 31.03.2008 | Oral Presentation: Proceedings of the Vetoalp 2008 Conference, March 2008, Chamonix, France, p. 69 Praevalenz von Bartonellen und haemotrophen Mykoplasmen in Flohpopulationen von Hunden und Katzen 05.03.2008 | Tagung der DVG - Fachgruppe Parasitologie und parasitäre Krankheiten   Evaluation of the efficacy and safety of a novel formulation of metaflumizone plus amitraz in dogs naturally infest ... 15.12.2007 | Veterinary Parasitology 2007; 50 (3): 239-245 Evaluation of the efficacy and safety of a novel formulation of metaflumizone in cats naturally infested with fleas ... 15.12.2007 | Veterinary Parasitology 2007, 50 (3): 246-250 * KLIFOVET AG; ** Fort Dodge Animal Health; *** Ludwig-Maximilian-University, Mun ... Efficacy of ProMeris for cats and ProMeris Duo for dogs in Europe 22.08.2007 | Proceedings of the 21st Int. Conference of the WAAVP 2007, Gent, Belgium. Editors: E. Claerebout, J. Vercruysse Prevalence of haemotrophic Mycoplasma and Bordetella spp. in fleas of companion animals from Germany and France 20.08.2007 | Proceedings of the WAAVP 2007, Gent, Belgium. Editors: E. Claerebout, J. Vercruysse Clinically relevant biochemical abnormalities in ketone body-responsive cows with abomasal dislocation to the left 20.08.2007 | Proceedings of the 13th International Conference on Production Diseases in Farm Animals, Leipzig, Germany. Page 200 Behandlung von degenerativen Gelenkserkrankungen des Hundes mit Zeel ad us. vet. im Vergleich zu Carprofen 20.08.2007 | Kleintiermedizin Nr. 7/8-07 Juli-August 2007 Praevalenz von Bartonellen und haemotrophen Mykoplasmen in Flohpopulationen von Hunden und Katzen 05.06.2007 | Tagung der DVG, Fachgruppe Parasitologie und parasitäre Krankheiten. 4.-6. Juni 2007, Celle, Germany Prevalence of Bartonella and ... Bacteriological and virological status in upper respiratory tract infections in cats 09.03.2007 | Berl. Münch. Tierärztl. Wochenschr. 120, 120-125 (2007) How can Animal Health Companies best benefit from Outreach Programmes - the Part IV perspective 19.10.2006 | Strategic Alliances in the Animal Health Industry. 30-31 October 2006. Hotel Palace Berlin, Germany. Informa Life Sciences Confere ... Efficacy and Safety of Catosal(r) in the Concomitant Treatement of Ketosis in Cows with left Abomasal Displacement 19.10.2006 | Poster accepted: XXIVth World Buiatrics Congress, Nice, France, October 2006 Field Evaluation on the Clinical Efficacy of Neo-Ancemin in the Treatment of Cattle with Clinical Signs of Alimenta ... 18.09.2006 | Poster at the 10th EAVPT International Congress September 2006, Turin, Italy Development of Veterinary Medicinal Products - Clinical Field Studies 13.09.2006 | Animal Pharm Veterinary Medicines Summer School, 11.-13. September 2006, Cambridge, UK Novel Fluoroquinolone Pradofloxacine: Clinical Efficacy and Safety in the Treatment of Feline Wound Infections and ... 03.09.2006 | 10th EAVPT, Turin, Italy; 17-22. September 2006 Metaphylactic Efficacy of in-feed lincomycin and spectinomycin combination against post-weaning diarrhoea in growin ... 08.07.2006 | Poster: IPVS, Copenhagen, 2006 Clinical Efficacy of Catosal in the Treatment of Ketosis of Cows 23.05.2006 | Tierärztl. Umschau 61 (4), 187,190 (2006) Comparison of the effect of Zeel ad us.vet. in lameness of horses caused by non-infetious arthropthy to the effect ... 29.03.2006 | Der Praktische Tierarzt 87: 5 (2006), 362-370 Clinical and epidemiological characteristics of Eimeria infections in first-year grazing cattle 28.03.2006 | Veterinary Parasitology 136 (2006), 215-221 Treatment of clinical mastitits with Advocid(r) 180 05.03.2006 | Grosstierpraxis 7:01, 38-41 (2006) Experiences with the collection of veterinary clinical pathogens from bacterial diseases of target animals 23.01.2006 | Submitted and accepted: Poster AAVM, Orlando, 2006 Efficacy of toltrazuril as a metaphylactic and therapeutic treatment of coccidiosis in first-year grazing calves 24.10.2005 | Parasitol Res (2005) 97: 127-133 Evaluation of the efficacy and safety of imidacloprid 10% plus moxidectin 2.5% spot-on in the treatment of generali ... 24.10.2005 | Parasitol Res (2005) 97: 89-96 Efficacy and safety of imidacloprid 10% plus moxidectin 2.5% spot-on in the treatment of sarcoptic mange and otoaca ... 24.10.2005 | Parasitol Res (2005) 97: 81-88 Field Evaluation of the Safety and Efficacy of Emodepside / Praziquantel spot-on solution against naturally acquire ... 24.10.2005 | Parasitol Res (2005), 97: 58-64 Clinical Evaluation of the metaphylactic and therapeutic Efficacy and Safety of Baycox Vet. (Toltrazuril) in the Tr ... 19.10.2005 | WAAVP 2005, Christchurch, New Zealand Field Evaluation of the Safety and Efficacy of Emodepside Plus Praziquantel Spot-On against Nematode and Cestode In ... 19.10.2005 | WAAVP 2005, Christchurch, New Zealand Imidacloprid 10% + Moxidectin 2.5% spot on for treatment of canine infection with sarcoptes spp.: results of a Euro ... 14.10.2005 | WAAVP 2005, Christchurch, New Zealand Imidacloprid 10% + Moxidectin 2.5% spot on for treatment of canine generalised demodicosis: results of a European f ... 14.10.2005 | WAAVP 2005, Christchurch, New Zealand Recent investigations on the prevalence of gastrointestinal nematodes in cats and dogs from France and Germany 14.10.2005 | WAAVP 2005, Christchurch, New Zealand Efficacy and Safety of Catosal in the concomitant treatment of ketosis in cows with left abomasal displacement 04.10.2005 | Poster: Buiatrissima 2005, Bern, CH Bacteriological and virological status in feline upper respiratory tract infections 16.09.2005 | DVG: AVID-Tagung 2005, Kloster Banz Clinical Efficacy of Pradofloxacin in the Treatment of Feline Upper Respiratory Tract Infections 19.07.2005 | Conference of the American Society for Microbiology (2005) Imidacloprid 10% und Moxidectin 2.5% spot-on (Advocate) zur Behandlung der Demodikose des Hundes 23.06.2005 | DVG Parasitologie: Diagnostik, Epidemiologie und Bekämpfung von Parasitosen bei Nutz-, Haus- und Heimtieren, Potsdam 2005 Imidacloprid 10% und Moxidectin 2.5% Spot-on (Advocate) zur Behandlung der Sarkoptesräude des Hundes 23.06.2005 | DVG Parasitologie: Diagnostik, Epidemiologie und Bekämpfung von Parasitosen bei Nutz-, Haus- und Heimtieren, Potsdam 2005 Topical tea tree oil effective in canine localised pruritic dermatitis - a multi-centre randomised double-blind con ... 26.11.2004 | Deutsche Tierärztliche Wochenschrift, 10/2004 Teebaumöl bei Dermatitis mit Juckreiz - eine randomisierte Doppelblindstudie bei Hunden 16.07.2004 | Kleintiermedizin 5/6 (2004) Survey of the use of Cobactan 2.5% in veterinary practice: Small and companion animals 02.07.2004 | Survey of the use of Cobactan 2.5 % in veterinary practice: Horse 02.07.2004 | Tierärztliche Umschau 7, 410-411 (2004) Survey of the use of Cobactan suspension 2.5 % in veterinary practice: Swine 23.06.2004 | Tierärztliche Umschau 59, 356-358 Survey of the use of Cobactan suspension 2.5 % in veterinary practice: Cattle 23.06.2004 | Tierärztliche Umschau 59, 356-358 Field Study to evaluate the efficacy of toltrazuril in coccidiosis on pasture in cattle in northern Germany 11.06.2004 | DVG Parasitologie (2004): Aktuelles zu Diagnostik und Therapie von Parasitosen von Klein- und Heimtieren, 9.-11. June 2004, Starnb ... Bakteriologische Isolierungsergebnisse in Abhängigkeit von der Methodik. 03.09.2003 | 22. Arbeits- und Fortbildungstagung des AVID - Bakteriologie, 17. - 19. Sept. 2003, Kloster Banz Recent investigation on the prevalence of gastrointestinal nematodes in cats from France and Germany 19.08.2003 | Parasitol Res 90, 2003: 146-147 European multicenter field trial on the efficacy and safety of a topical formulation on Imidacloprid and Permethrin ... 19.08.2003 | Parasitol Res 90, 2003: 125-126 The anthelmintic efficacy and the safety of a combination of Imidacloprid and Moxidectin spot-on in cats and dogs u ... 19.08.2003 | Parasitol Res 90, 2003: 142-143 Clinical efficacy and safety of pradofloxacin in the treatment of canine pyoderma and wound infections under field ... 11.07.2003 | 9th International EAVPT Congress, 13-18 July 2003, Lisbon, Portugal. Poster Presentation The anthelmintic efficacy and the safety of a combination of imidacloprid and moxidectin spot-on in dogs and cats u ... 10.07.2003 | 19th WAAVP conference, 10-14 August 2003, New Orleans, Louisiana, USA Prävalenzen von Floharten bei Hunden (prevalence of flea species in dogs) 20.03.2003 | DVG Tagung der Fachgruppe Parasitologie, Leipzig, 20.-21. März 2003 A comparative field study of the efficacy of Cefquinome and Amoxycillin against acute meningitis of weaned piglets. 14.01.2003 | Pig Journal 50, 2002: 28-41 Die klinische Wirksamkeit von Cefquinom (Cobactan 2,5% Injektionslösung) in der Behandlung der Epidermitis exsudati ... 15.05.2002 | Tierärztliche Umschau 57(7), 2002: 367-374. Clinical efficacy of Cefquinome in the treatment of exudative epidermitis in pigs. 13.05.2002 | IPVS Conference 2002, 2-5 June 2002, Ames, Iowa, USA. Poster Presentation A comparative field study on the efficacy of Cefquinome and Amoxicillin against acute meningitis of weaned piglets. ... 13.05.2002 | IPVS Conference 2002, 2-5 June 2002, Ames, Iowa, USA. Poster Presentation Verkürzung der Messdauer bei der rektalen Temperaturmessung in der tierärztlichen Praxis 20.12.2001 | Tierärztliche Umschau 56(12), 2001: 657-661. Was beinhaltet der Kodex „Gute Veterinärmedizinische Praxis? 22.09.2001 | German Veterinary Congress, Hanover, Germany Gute Veterinärmedizinische Praxis (GVP) – lästige Pflicht, überflüssig oder nützlich? 20.09.2001 | German Veterinary Congress, Hanover, Germany, 2001 Seminar: Qualitätsmanagement in der Tierarztpraxis Expertise required for monitors, investigators and CRO’s 18.09.2001 | LMU, EMEA/CVMP, FEDESA Workshop on VICH GCP, Munich, Germany Qualitätssicherung (QS) und Qualitätsmanagement (QM): Bedeutung für die tierärztliche Praxis (Teil 1) 31.08.2001 | Der Praktische Tierarzt 82(3) 2001, BPT Info: 8-9 Epidemiological Data: Conducting Field Studies Testing Parasiticides in Pets 30.08.2001 | 18. WAAVP Conference 2001, Stresa, Italy Guidelines on Clinical Field Studies Testing Parasiticides 30.08.2001 | 18. WAAVP Conference 2001, Stresa, Italy Wirksamkeit von Danofloxacin bei der Behandlung von E. coli-Durchfall bei Ferkeln 27.05.2001 | Bayerischer Tierärztetag 2001, München: Seminar Responsibilities of the investigator according to VICH GCP 25.05.2001 | Bayerischer Tierärztetag, München, 2001 Seminar Qualitätsmanagement in der Tierarztpraxis Qualitätssicherung (QS) und Qualitätsmanagement (QM): Bedeutung für die tierärztliche Praxis (Teil 2) 01.04.2001 | Der Praktische Tierarzt, 82. Jg, 4.2001, BPT INFO, Seite 9 – 10 Qualitätsmanagement im Labor: Systeme, Anforderungen und Zertifizierung – EU, WTO, OIE 28.03.2001 | International Training Course Deutsche Stiftung für Internationale Entwicklung (DSE), Feldafing bei München TAIEX/FVE: Consequences of Privatisation of Veterinary Practices in the Candidate Countries Krakow, Poland 23.03.2001 | Qualitaetsmanagement (QM): Bedeutung fuer die tieraerztliche Praxis (Teil 1) 01.03.2001 | Der PraktischeTierarzt, 82 Jg,3.2001, BPT INFO, Seite 8 – 9 Comparative efficacy of Flunixin in the treatment of bovine enzootic pneumonia in cattle 01.03.2001 | Der Praktische Tierarzt, 82. Jg, 3.2001, Page 190-196 Die klinische Wirksamkeit von Danofloxacin 2,5% (Advocin(R)) bei der Behandlung von Escherichia coli-Infektionen so ... 05.01.2001 | Tierärztl. Umschau 5, 2001: 235-243 Efficacy of selamectin against experimentally induced and naturally acuired ascarid (Toxocara canis and Toxocara le ... 23.08.2000 | Veterinary Parasitology 91 (2000), 333-345 Good Clinical Practice: Review and Expectation 02.08.2000 | 8th International Congress of the European Association of Veterinary Pharmacology and Toxicology (EAVPT) Jerusalem, Israel Good Clinical Practice: Practical Experience and Expectations 09.11.1999 | Annual Assembly of the British Association of Research Quality Assurance (BARQA) Harrogate, UK Experiences Monitoring Clinical Studies Testing Parasiticides in Pets 17.08.1999 | 17th International Conference of the World Association for the Advancement of Veterinary Parasitology (WAAVP) Copenhagen, Denmark Fettsaeuren-Peroxidation und Vitamin E-Gehalt in Eberspermien 01.01.1993 | Vitamine und weitere Zusatzstoffe bei Mensch und Tier, 4. Symposium, Jena, Deutschland Subklinische Mastitis: Voraussetzung für Sanierung und Therapie 01.01.1993 | Tierärztliche Umschau 48, 356-364 Lipid Peroxidation in Boar Semen. A Relevant Aspect of Semen Storage? 01.01.1991 | Boar Semen Preservation II: Proceedings - Supplement 1 to: Reproduction of domestic animalsm, Paul Parey Verlag, Berlin und Hambur ...