 |
|
 |
 |
 |
 |
 |
Gazette APVMA 3, 1 March 2005 page 11
NOTICE OF REGISTRATION OF AGRICULTURAL AND VETERINARY CHEMICAL PRODUCTS
Pursuant to the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994, the APVMA hereby gives notice that it has registered or varied the registration in respect of the following products, with effect from the dates shown.
VETERINARY CHEMICAL PRODUCTS
1. RESTRICTED PRODUCT:
Product Name:
Active Constituent/s:
Applicant Name:
Applicant ACN:
Summary of Use:
Date of Registration:
Label Approval No:
“ No Entries”
2. VETERINARY PRODUCTS BASED ON NEW ACTIVE CONSTITUENTS:
Product Name:
Active Constituent/s:
Applicant Name:
Applicant ACN:
Summary of Use:
Date of Registration:
Label Approval No:
“ No Entries”
3. VETERINARY PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS:
Product Name:
Active Constituent/s:
Applicant Name:
Applicant ACN:
Summary of Use:
Date of Registration:
Label Approval No:
Product Name: Smartshot B12 Long Acting Vitamin B12 Injection For Sheep.
Active Constituent/s: 6 mg/ml vitamin B12A = hydroxocobalamin
Applicant Name: Agresearch Limited
Summary of Use: For long term prevention and treatment of Colbalt/Vitamin B12 deficiencies in sheep.
Date of Registration: 01 December 2004
Label Approval No: 51158/200ML/1004, 51158/500ML/1004
Product Name: Chlortet 200 Powder Feed Additive
Active Constituent/s: 200 g/kg chlortetracycline hydrochloride as calcium complex
Applicant Name: J H Veterinary Pty Ltd
Applicant ACN: 106 770 558
Summary of Use: Feed additive for use in calves, pigs, poultry for prophylactic use when at risk from diseases and for treatment of diseases caused my micro-organisms susceptible to chlortetracycline.
Date of Registration: 06 December 2004
Label Approval No: 56640/25KG/1204
Product Name: Phoenectin (Ivermectin) Pour-On For Cattle
Active Constituent/s: 5 g/L ivermectin
Applicant Name: Phoenix Scientific Inc
Summary of Use: For the treatment and control of Ivermectin sensitive internal and external parasites of beef and dairy cattle.
Date of Registration: 20 December 2004
Label Approval No: 58641/250mL/0704, 58641/500mL/0704, 58641/1L/0704, 58641/3.8L/0704, 58641/5L/0704, 58641/25L/0704
Product Name: Aquatopia Australia Fungus Eliminator
Active Constituent/s: 2 mg/mL acriflavine,
0.40 mg/mL malachite green
Applicant Name: Aquatopia Australia Pty Ltd
Applicant ACN: 101 954 938
Summary of Use: For the treatment of fungal diseases in freshwater and tropical freshwater aquarium fish.
Date of Registration: 23 December 2004
Label Approval No: 59121/2/1104, 59121/500/1104, 59121/250/1104, 59121/125/1104, 59121/50/1104
Product Name: Cydectin Eweguard 6 In 1
Vaccine And Wormer With Selenium And
Vitamin B12 For Sheep
Active Constituent/s: 1 mg/mL vitamin B12 - hydroxocobalamin acetate, 5 mg/mL moxidectin, 1 mg/mL selenium as sodium selenate, antigens of cheesy gland [C.pseudotuberculosis (ovis)], enteotoxaemia (cl .perfringens type D), blackleg (Cl. Chauvoei), malignant oedema (Cl. Septicum), black disease (Cl. Novyi type B) and tetanus (Cl. Tetani)
Applicant Name: Fort Dodge Australia Pty Limited
Applicant ACN: 000 074 902
Summary of Use: For the prevention of cheesy gland caused by Cornyebacterium pseudotuberculosis, enterotoxaemia caused by Clostridium perfringens type D, blackleg caused by Clostridium chauvoei, malignant oedema caused by Clostridium septicum, black disease caused by Clostridium novyi B, tetanus caused by Clostridium tetani. For the treatment and control of internal parasities, nasal bot and itchmite in sheep and as a supplementary source of vitamin B12 and selenium.
Date of Registration: 10 January 2005
Label Approval No: 58527/200mL/1204, 58527/500mL/1204 58527/1204
Product Name: Milbemax Tablets For Small
Dogs And Puppies
Active Constituent/s: Each tablet contains
2.5mg milbemycin oxime, 25mg praziquantel
Applicant Name: Novartis Animal Health
Australasia Pty Limited
Applicant ACN: 076 745 198
Summary of Use: Treats and controls
roundworm, whipworm, hookworm, tapeworm
and prevents heartworm.
Date of Registration: 11 January 2005
Label Approval No: 59225/10T/1004,
59225/20T/1004, 59225/50T/1004,
59225/100T/1004, 59225/1004
Product Name: Aquatopia Australia Aqua-Cycline Tablets
Active Constituent/s: Each tablet contains 375 mg tetracycline hydrochloride
Applicant Name: Aquatopia Australia Pty Ltd
Applicant ACN: 101 954 938
Summary of Use: Broad spectrum antibiotic for the treatment of diseases in ornamental fresh and saltwater aquarium fish caused by tetracycline-sensitive bacteria.
Date of Registration: 11 January 2005
Label Approval No: 59117/25/1204, 59117/100/1204
Product Name: Doxycycline 50 Antibiotic Tablets
Active Constituent/s: Each tablet contains 50 mg doxycycline (as monohydrate)
Applicant Name: Apex Laboratories Pty Ltd
Applicant ACN: 000 397 240
Summary of Use: For the treatment of bacterial infections caused by organisms sensitive to doxycycline in dogs and cats.
Date of Registration: 13 January 2005
Label Approval No: 58341/150/0604, 58341/0604
Product Name: Bomazeal Senior Palatable Tablets
Active Constituent/s: Each tablet contains 175 mg green lipped mussel, 100 mg shark cartilage
Applicant Name: Bomac Laboratories Limited (NZ)
Summary of Use: A mixture of glycosaminoglycans from marine sources which may aid in the relief of the symptoms of canine arthritis.
Date of Registration: 17 January 2005
Label Approval No: 58334//100/0105, 58334/300/0105
Product Name: PCL Intravaginal Insert
Active Constituent/s: 1.38 g per insert progesterone
Applicant Name: Interag
Summary of Use: Intravaginal insert containing Progesterone for use in controlled breeding cattle.
Date of Registration: 17 January 2005
Label Approval No: 58826/10/0105
Product Name: Aquatopia Australia Para Blast Tablets
Active Constituent/s: Each tablet contains 20 mg trichlorfon
Applicant Name: Aquatopia Australia Pty Ltd
Applicant ACN: 101 954 938
Summary of Use: Controls external parasite infestations in fresh and saltwater aquarium fish.
Date of Registration: 19 January 2005
Label Approval No: 59123/25/1104, 59123/100/1104
Product Name: Androhep Boar Semen
Extender Powder
Active Constituent/s: 20 g/kg
neomycin sulfate
Applicant Name: Minitube Australia
Pty Limited
Applicant ACN: 107 801 669
Summary of Use: For the protection of pig semen during dilution, storage and transport for insemination of gilts and sows.
Date of Registration: 19 January 2005
Label Approval No: 57754/49.5g/1204, 57754/247.5g/1204, 57754/495g/1204, 57754/5kg/1204
Product Name: Value Plus Fly Spray
Active Constituent/s: 3 g/L N-octyl bicycloheptene dicarboximide, 6 g/L di-N-propyl isocinchomeronate, 2.7 g/L piperonyl butoxide, 1.5 g/L pyrethrins
Applicant Name: C M Laboratories Pty Ltd
Applicant ACN: 098 897 637
Summary of Use: Repels flies and mosquitoes on horses, dogs, cattle and pigs. Controls fleas (Ctenocephalides sp) and lice (Heterodoxus sp, Linognathus sp, Trichodectes sp and Felicola sp) on dogs and cats.
Date of Registration: 20 January 2005
Label Approval No: 59368/125/1104, 59368/500/1104, 59368/5/1104
Product Name: Androhep Enduraguard Boar
Semen Extender Powder
Active Constituent/s: 21 g/kg neomycin sulfate
Applicant Name: Minitube Australia Pty
Limited
Applicant ACN: 107 801 669
Summary of Use: For the protection of pig semen during dilution, storage and transport for insemination of gilts and sows.
Date of Registration: 20 January 2005
Label Approval No: 57755/47g/1204, 57755/470g/1204, 57755/4.7kg/1204
Product Name: Aquatopia Australia Tri-Sulfa
Tablets
Active Constituent/s: Each tablet contains
154.7 mg sulfadimidine, 154.1 mg
sulfamerazine as the monosodium salts,
153.5 mg sulfadiazine
Applicant Name: Aquatopia Australia Pty Ltd
Applicant ACN: 101 954 938
Summary of Use: An aid in the control of white
spot (Ichthyophthirius mutifiliis), mouth and
body fungus (Columnaris spp), fin and tail rot
and other external bacterial diseases of fish in
fresh and saltwater aquariums.
Date of Registration: 21 January 2005
Label Approval No: 59125/15/1204,
59125/100/1204
Product Name: Vetsense Neutracid Mild
Diuretic And Urinary Buffer For Horses And
Greyhounds
Active Constituent/s: 285 g/L sodium acid citrate
Applicant Name: C M Laboratories Pty Ltd
Applicant ACN: 098 897 637
Summary of Use: A mild diuretic and alkaliniser which may aid in the treatment or prevention of acidosis and assist as an adjunctive in the specific treatment of bladder infections in horses and dogs.
Date of Registration: 21 January 2005
Label Approval No: 59034/500mL/0105, 59034/1L/0105, 59034/5L/0105, 59034/20L/0105
Product Name: Aquatopia Australia White
Spot Eliminator
Active Constituent/s: 37 mg/mL formaldehyde,
0.32 mg/mL malachite green
Applicant Name: Aquatopia Australia Pty Ltd
Applicant ACN: 101 954 938
Summary of Use: For treatment of white spot
(Ichthyophthirius multifiliis) in freshwater and
tropical freshwater aquarium fish.
Date of Registration: 21 January 2005
Label Approval No: 59126/50/1104,
59126/125/1104, 59126/250/1104,
59126/500/1104, 59126/2/1104
Product Name: Gromax Anticoccidial Premix
Active Constituent/s: 7.5 g/kg maduramicin ammonium, 80.0 g/kg nicarbazin
Applicant Name: Alpharma Inc.
Summary of Use: For use in broiler chickens for prevention of coccidiosis caused by Eimeria acervulina, E. maxima and E. tenella and as an aid in the prevention of coccidiosis caused by E. necatrix, E. brunette and E. mivati.
Date of Registration: 27 January 2005
Label Approval No: 55130/25/1104
Product Name: Leader Stock Marker
Applicant Name: Rurtec Limited
Summary of Use: A scourable crayon marker for identification of livestock.
Date of Registration: 31 January 2005
Label Approval No: 59158/105/0105
Product Name: Merck III Boar Semen Extender Powder
Active Constituent/s: 16.7 g/kg neomycin sulfate
Applicant Name: Minitube Australia Pty Limited
Applicant ACN: 107 801 669
Summary of Use: For the protection of pig semen during dilution, storage and transport for insemination of gilts and sows.
Date of Registration: 31 January 2005
Label Approval No: 57756/60g/1204, 57756/300g/1204, 57756/5kg/1204
Product Name: BTS Boar Semen Extender Powder
Active Constituent/s: 20 g/kg neomycin sulfate
Applicant Name: Minitube Australia Pty Limited
Applicant ACN: 107 801 669
Summary of Use: For the protection of pig semen during dilution, storage and transport for insemination of gilts and sows.
Date of Registration: 1 February 2005
Label Approval No: 57757/50g/1204, 57757/250g/1204, 57757/500g/1204
Product Name: Vaxsafe ND Vaccine (living)
Active Constituent/s: >106.0 EID 50/D newcastle disease strain V-4 virus
Applicant Name: Bioproperties Pty Ltd
Applicant ACN: 007 303 728
Summary of Use: The vaccine is designed to control ND in broiler chickens caused by a range of pathogenic types of ND virus, to stimulate an active antibody response and to protect broiler chickens against challenge from ND virus.
Date of Registration: 7 February 2005
Label Approval No: 59142/1/0105, 59142/2/0105, 59142/5/0105, 59142/0105
4.VARIATIONS
Product Name:
Applicant Name:
Applicant ACN:
Summary of Variation:
Date of Variation:
Label Approval No:
Product Name: Ecomectin Cattle Pour-On
Applicant Name: Eco Animal Health Ltd
Summary of Variation: Approval of label change to allow administration of product to lactating dairy cattle.
Date of Variation: 18 January 2005
Label Approval No: 52711/250ML/0904, 52711/1L/0904, 52711/2.5L/0904, 52711/5L/0904, 52711/10L/0904, 52711/20L/0904
Product Name: Advocate For Dogs 4-10kg
Applicant Name: Bayer Australia Ltd (Animal Health)
Applicant ACN: 000 138 714
Summary of Variation: Extension of product claim to include treatment and control of ear mites (Otodectes cynotis) in dogs weighing 4-10kg.
Date of Variation: 20 January 2005
Label Approval No: 55321/1/0504, 55321/3/0504, 55321/6/0504, 55321/0504
Product Name: Advocate For Dogs 10-25kg
Applicant Name: Bayer Australia Ltd (Animal Health)
Applicant ACN: 000 138 714
Summary of Variation: Extension of product claim to include treatment and control of ear mites (Otedectes cynotis) in dogs weighing 10/25 kg.
Date of Variation: 20 January 2005
Label Approval No: 55322/1/0504, 55322/3/0504, 55322/6/0504
Product Name: Advocate For Puppies And
Small Dogs Up To 4kg
Applicant Name: Bayer Australia Ltd (Animal Health)
Applicant ACN: 000 138 714
Summary of Variation: Extension of use to include treatment of roundworm, hookworm, whipworm and lice, and treatment and control of generalised demodicosis.
Date of Variation: 20 January 2005
Label Approval No: 55320/1/0504, 55320/3/0504, 55320/6/0504, 55320/0504
Product Name: Advocate For Dogs Over 25kg
Applicant Name: Bayer Australia Ltd (Animal Health)
Applicant ACN: 000 138 714
Summary of Variation: Approval of additional claim for efficacy against sarcoptic mange mites on dogs over 25kg.
Date of Variation: 20 January 2005
Label Approval No: 55323/0504, 55323/1/0504, 55323/3/0504, 55323/6/0504
Product Name: Fungaflor 500 EC Janssen Fungicide Emulsifiable Concentrate
Applicant Name: Janssen-Cilag Pty Ltd
Applicant ACN: 000 129 975
Summary of Variation: Extension of use to potatoes and rockmelons (post-harvest).
Date of Variation: 2 February 2005
Label Approval No: 50350/1/1004
5.. RESTRICTED PRODUCT VARIATION
Product Name:
Applicant Name:
Applicant ACN:
Summary of Variation:
Date of Variation:
Label Approval No:
“ No Entries”