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Permits.nra.gov.au

AUSTRALIAN PESTICIDES & VETERINARY MEDICINES AUTHORITY
Application Summary for Application No 49811
Application Details:
Product Name:
EXODUS TRIPLE DRENCH FOR SHEEP AND LAMBS Product No:
Applicant Name:
Application
Registration of a 0.1% Moxidectin, 4% Levamisole HCI, 2.38% Albendazole, 0.05% Selenium and 0.22% Cobalt oral drench product for the treatment Purpose and
and control of gastrointestinal parasites, lungworm, nasal bot and itch mite in sheep.
Description of
Use:

Active Constituent Name
Reference Product
Reference Product Name
Description of Data Provided
Applicants
Auth Party
Publication
Authorising Party
Reference
Contact Address
artificially induced infection of recent field isolates of Teladorsagia (Ostertagia) spp. and Haemonchus spp. in sheep - clinical end-point bioequivalence.
AUSTRALIAN PESTICIDES & VETERINARY MEDICINES AUTHORITY
Application Summary for Application No 49811
Applicants
Auth Party
Publication
Authorising Party
Reference
Contact Address
Moxidectin 3 Way Hi- Mineral oral drench against an artificially induced infection of spp. in sheep - clinical end-point bioequivalence.
Moxidectin certificate of analysis- Batch SHEA TERRACE TAKAPUNA AUCKLAND 0622 NEW ZEALAND Manufacturing process and quality control 1ST FLOOR, 17 SHEA TERRACE TAKAPUNA AUCKLAND 0622 NEW ZEALAND SHEA TERRACE TAKAPUNA AUCKLAND 0622 NEW ZEALAND AUSTRALIAN PESTICIDES & VETERINARY MEDICINES AUTHORITY
Application Summary for Application No 49811
Applicants
Auth Party
Publication
Authorising Party
Reference
Contact Address
Levamisole hydrochloride certificalte of SHEA TERRACE TAKAPUNA AUCKLAND 0622 NEW ZEALAND European Agency for the Evaluation of Medicinal Products - Moxidectin (5) Extension to ovine milk.
European Agency for the Evaluation of Medicinal Products - Moxidectin (3) Modification of the ADI and extension to bovine milk.
Levamisole hydrochloride certificates of SHEA TERRACE TAKAPUNA AUCKLAND 0622 NEW ZEALAND http://www.fda.gov/downloads/AdvisoryCommittees/./UCM127124.pdf, July 2010 AUSTRALIAN PESTICIDES & VETERINARY MEDICINES AUTHORITY
Application Summary for Application No 49811
Applicants
Auth Party
Publication
Authorising Party
Reference
Contact Address
Stability Studies of Moxi 3 Way Drench - feasibility of initiation the first phase II Validation of test method number 129-00, Therapeutic efficacy against susceptible combination moxidectin, levamisole and albendazole drench (Moxi 3-way Hi Min) when administered orally to sheep. (Artificial Infection, Faecal Egg Count Reduction and Sacrifice Study).
AUSTRALIAN PESTICIDES & VETERINARY MEDICINES AUTHORITY
Application Summary for Application No 49811
Applicants
Auth Party
Publication
Authorising Party
Reference
Contact Address
Therapeutic efficacy against susceptible spathiger of a combination moxidectin, levamisole and albendazole drench (Moxi 3-way Hi Min) when administered orally to sheep. (Artificial Infection, Faecal Egg Count Reduction and Sacrifice Study) Therapeutic efficacy against susceptible spathiger of a combination moxidectin, levamisole and albendazole drench (Moxi 3-way Hi Min) when administered orally to sheep. (Artificial Infection, Faecal Egg Count Reduction and Sacrifice Study) Nematodirus spathiger of a combination moxidectin, levamisole and albendazole drench (Moxi 3-way Hi Min) when administered orally to sheep. (Artificial Infection, Faecal Egg Count Reduction and Sacrifice Study).
AUSTRALIAN PESTICIDES & VETERINARY MEDICINES AUTHORITY
Application Summary for Application No 49811
Applicants
Auth Party
Publication
Authorising Party
Reference
Contact Address
The pharmacokinetics of moxidectin after the neutrophil function and severity of Ostertagia infection in cattle.
Seminar, Society of Sheep and Beef Cattle Veterinarians NZVA, Vetlearn Foundation (NZ) 2003. 147-151.
SHEA TERRACE TAKAPUNA AUCKLAND 0622 NEW ZEALAND Stability testing results, freeze and thaw 1ST FLOOR, 17 SHEA TERRACE TAKAPUNA AUCKLAND 0622 NEW ZEALAND AUSTRALIAN PESTICIDES & VETERINARY MEDICINES AUTHORITY
Application Summary for Application No 49811
Applicants
Auth Party
Publication
Authorising Party
Reference
Contact Address
SHEA TERRACE TAKAPUNA AUCKLAND 0622 NEW ZEALAND Sodium selenate certificate of analysis - SHEA TERRACE TAKAPUNA AUCKLAND 0622 NEW ZEALAND Sodium selenate certificate of analysis - SHEA TERRACE TAKAPUNA AUCKLAND 0622 NEW ZEALAND European Agency for the Evaluation of Medicinal Products - Moxidectin (2) Economics, Australian Commodity Statistics 2009, p177-178.
European Agency for the Evaluation of Medicinal Products - Moxidectin (1) Agency for the Evaluation of Medicinal Products - Albendazole (Extrapolation to all ruminants) AUSTRALIAN PESTICIDES & VETERINARY MEDICINES AUTHORITY
Application Summary for Application No 49811
Applicants
Auth Party
Publication
Authorising Party
Reference
Contact Address
Handbook, 3rd ed, Iowa State University Press, Ames, 12-14, 432-436, 514-516.
SHEA TERRACE TAKAPUNA AUCKLAND 0622 NEW ZEALAND SHEA TERRACE TAKAPUNA AUCKLAND 0622 NEW ZEALAND SHEA TERRACE TAKAPUNA AUCKLAND 0622 NEW ZEALAND SHEA TERRACE TAKAPUNA AUCKLAND 0622 NEW ZEALAND SHEA TERRACE TAKAPUNA AUCKLAND 0622 NEW ZEALAND AUSTRALIAN PESTICIDES & VETERINARY MEDICINES AUTHORITY
Application Summary for Application No 49811
Applicants
Auth Party
Publication
Authorising Party
Reference
Contact Address
Acceptable daily intakes for albendazole, AUSTRALIAN PESTICIDES & VETERINARY MEDICINES AUTHORITY
Application Summary for Application No 49811
Applicants
Auth Party
Publication
Authorising Party
Reference
Contact Address
Veterinary Pharmacology and Therapeutics, 8th ed., Iowa State University Press, Ames, 963, 947-957 & 972-973 Agency for the Evaluation of Medicinal Products - Albendazole (2) Agency for the Evaluation of Medicinal Products - Albendazole (1) AUSTRALIAN PESTICIDES & VETERINARY MEDICINES AUTHORITY
Application Summary for Application No 49811
Applicants
Auth Party
Publication
Authorising Party
Reference
Contact Address
Agency of Medicinal Products - Levamisole (1) and survival rate in lambs grazing cobalt-deficient pastures.
Determination of the anthelmintic efficacy Determination of the anthelmintic efficacy Determination of the anthelmintic efficacy Current issues in trace element nutrition of grazing livestock in Australia and New AUSTRALIAN PESTICIDES & VETERINARY MEDICINES AUTHORITY
Application Summary for Application No 49811
Applicants
Auth Party
Publication
Authorising Party
Reference
Contact Address
SHEA TERRACE TAKAPUNA AUCKLAND 0622 NEW ZEALAND RS (eds.): Macrocyclic Lactones in Antiparasitic Therapy. CABI Publishing, Wallingford, UK,2002, 75-96 intramuscular and oral administration in Agency for the Evaluation of Medicinal Products - Levamisole (2) AUSTRALIAN PESTICIDES & VETERINARY MEDICINES AUTHORITY
Application Summary for Application No 49811
Applicants
Auth Party
Publication
Authorising Party
Reference
Contact Address

Source: http://permits.nra.gov.au/application_summaries/49811.pdf

Rh37101250

British Journal of Rheumatology 1998; 37: 1102–1109 COST-EFFECTIVENESS AND COST-UTILITY OF COMBINATION THERAPY IN EARLY RHEUMATOID ARTHRITIS: RANDOMIZED COMPARISON OF COMBINED STEP-DOWN PREDNISOLONE, METHOTREXATE AND SULPHASALAZINE WITH SULPHASALAZINE ALONE A. C. VERHOEVEN, J. C. BIBO, M. BOERS, * G. L. ENGEL and Sj VAN DER LINDEN for the COBRA TRIAL GROUP Department of In

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