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
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
Biotin for Hair Introduction Biotin is often the first line of defense in hair loss. Biotin is known for its value to hair, skin and nails, and particularly for growing hair. Hair growth is one of its most important and often used benefits. Biotin vitamin is part of a healthy diet for beautiful, healthy skin and hair. Biotin supplements are an easy way to make sure you get enough biotin to