Veterinary Medicines

-0.08202752.071102SG8 0SSThe District of Aylesbury ValeThe Borough of RunnymedeThe District of South Cambridgeshire2005-02-282004-12-012005-03-25-0.98361851.988376MK18 1PA-0.49358251.353548KT15 3LS-0.50485753.233737LN3 4NPThe City of LincolnTSO (The Stationery Office), St Crispins, Duke Street, Norwich, NR3 1PD, 01603 622211, customer.services@tso.co.uk258082002/64

Vetrinary Medicines

Department for Environment, Food and Rural Affairs

VETERINARY MEDICINES DIRECTORATE

Woodham Lane, New Haw, Addlestone, Surrey KT15 3LS

VETERINARY MARKETING AUTHORISATION MA & EUDE VARIATIONS GRANTED UNDER THE VETERINARY MEDICINAL REGULATIONS 1994

1 December 2004 to 28 February 2005

Product Number

Company Name

Product Name

Variations Granted

Application Number

Legal Category

13997/4014

Alpharma As

Decoquinate

Product name changed to Deccox

00980/2004

MFS

01732/4098

Arnolds Veterinary Products Ltd

Soloxine 0.8

Change of marking on tablets

00855/2004

POM

01732/4095

Arnolds Veterinary Products Ltd

Soloxine 0.2

Change of marking on tablets

00849/2004

POM

01732/4094

Arnolds Veterinary Products Ltd

Soloxine 0.1mg

Change of marking on tablets

00846/2004

POM

01732/4097

Arnolds Veterinary Products Ltd

Soloxine 0.5

Change of marking on tablets

00853/2004

POM

01732/4096

Arnolds Veterinary Products Ltd

Soloxine 0.3

Change of marking on tablets

00851/2004

POM

20889/4005

Bio-Tech Solutions Ltd

Johnson’s 4Fleas Shampoo for Dogs

Additional pack size of 5 litres

01208/2004

GSL

00844/4215

Day Son And Hewitt Ltd

Lice Killing Shampoo

MA Holder changed to: Battle, Haywood & Bower Ltd, Crofton Drive, Lincoln LN3 4NP

01624/2004

GSL

00844/4211

Day Son And Hewitt Ltd

Radiol Insecticidal Soapless Shampoo With Conditioner

MA Holder changed to: Battle, Haywood & Bower Ltd, Crofton Drive, Lincoln LN3 4NP

01662/2004

GSL

00844/4208

Day Son And Hewitt Ltd

Sweet Itch Lotion

MA Holder changed to:

Battle, Haywood & Bower Ltd, Crofton Drive, Lincoln LN3 4NP

01663/2004

GSL

00844/4209

Day Son And Hewitt Ltd

Dermoline Shampoo For Horses

MA Holder changed to:

Battle, Haywood & Bower Ltd, Crofton Drive, Lincoln LN3 4NP

01665/2004

GSL

16849/4004

Eurovet Animal Health Bv

Octacillin Water Soluble Powder for Chickens 697 Mg/g

Product shelf-life extended

01585/2004

POM

01596/4301

Fort Dodge Animal Health

Dysect Sheep Pour-On

Addition of precautionary statement for use

01487/2004

PML

01596/4293

Fort Dodge Animal Health

Cydectin 0.1% w/v Oral Drench For Sheep

Withdrawal Period introduced for lactating ewes

00898/2004

PML

01596/4171

Fort Dodge Animal Health

Kloxerate Gold Dc

Withdrawal Period increase for cows milk

01112/2004

POM

06376/4006

Intervet International BV

Engemycin 5%

Withdrawal Period increase for cows milk

00511/2004

POM

06376/4006

Intervet International BV

Engemycin 5%

Withdrawal Period increase for pig meat

00512/2004

POM

06376/4006

Intervet International BV

Engemycin 5%

Contraindicated for use in sheep producing milk for human consumption

00513/2004

POM

06376/4006

Intervet International BV

Engemycin 5%

Withdrawal Period increase for sheep meat

00590/2004

POM

06376/4006

Intervet International BV

Engemycin 5%

Withdrawal Period increase for cattle meat

00510/2004

POM

06376/4007

Intervet International BV

Engemycin 10% Dd

Withdrawal Period increase (5 day dosing) for sheep meat

00515/2004

POM

06376/4007

Intervet International BV

Engemycin 10% Dd

Withdrawal Period increase (5 day dosing/2 treatments) for cows milk

00591/2004

POM

06376/4007

Intervet International BV

Engemycin 10% Dd

Contra-indicated for use in sheep producing milk for human consumption

00517/2004

POM

06376/4027

Intervet International BV

Porcilis PRRS

Remove contra-indication for use in breeding pigs

00418/2003

POM

01708/4374

Intervet Uk Ltd

Engemycin 10% Farm Pack

Withdrawal Period increase (5 day dosing) for sheep meat

00521/2004

POM

01708/4374

Intervet Uk Ltd

Engemycin 10% Farm Pack

Withdrawal Period increase (5 day dosing/2 treatments) for cows milk

00519/2004

POM

01708/4374

Intervet Uk Ltd

Engemycin 10% Farm Pack

Contra-indicated for use in sheep producing milk for human consumption

00589/2004

POM

00043/4078

Leo Laboratories Ltd

Fuciderm

Product name changed to Fuciderm Gel

00183/2004

POM

02000/4188

Norbrook Laboratories Limited

Sheptaclox DC

Withdrawal Period increase for cows milk

00402/2004

POM

02000/4185

Norbrook Laboratories Limited

Noroclav Injection

Addition of dogs as a target species

00257/2004

POM

02000/4154

Norbrook Laboratories Limited

Penacare

Withdrawal Period increase for cows milk

00188/2004

POM

02000/4152

Norbrook Laboratories Limited

Hexasol LA

In Use Shelf Life increased to 28 days

00963/2004

POM

12501/4062

Novartis Animal Health Uk Ltd

Armitage Pet Care Single Dose Wormer for Dogs and Puppies

MA Holder address changed to: New Cambridge House, Litlington, Nr Royston, Herts SG8 0SS

01443/2004

GSL

12501/4061

Novartis Animal Health Uk Ltd

Armitage Pet Care Single Dose Wormer for Small Dogs and Puppies

MA Holder address changed to: New Cambridge House, Litlington, Nr Royston, Herts SG8 0SS

01444/2004

GSL

12501/4149

Novartis Animal Health Uk Ltd

Johnson’s 4Fleas 57mg Tablets for Dogs

Additional Pack Size of 3 tablets

01646/2004

GSL

12501/4150

Novartis Animal Health Uk Ltd

Johnson’s 4Fleas 11.4mg, Tablets for small dogs and puppies

Additional Pack Size of 3 tablets

01647/2004

GSL

12501/4151

Novartis Animal Health Uk Ltd

Johnson’s 4Fleas 11.4mg Tablets for Small Cats and Kittens

Additional Pack Size of 3 tablets

01648/2004

GSL

12501/4021

Novartis Animal Health Uk Ltd

Combinex Cattle

Withdrawal Period increase for cattle meat

01370/2004

PML

12501/4027

Novartis Animal Health Uk Ltd

Utocyl

Withdrawal Period increase for cattle meat

01635/2004

POM

12501/4027

Novartis Animal Health Uk Ltd

Utocyl

Withdrawal Period increase for cows milk

01280/2004

POM

03649/4000

Orion Corporation

Domosedan 10mg/ml Injection

Withdrawal Period increase for horse meat

01139/2004

POM

00057/4235

Pharmacia & Upjohn Animal Health Ltd

Veramix Sheep Sponge

MA Holder name changed to: Pfizer Ltd, Ramsgate Road, Sandwich, Kent

01490/2004

POM

00201/4181

Schering Plough Ltd

Isoxetol

Product shelf-life extended

01416/2004

POM

00201/4147

Schering Plough Ltd

Rotavec Corona

Product shelf-life extended

00274/2004

POM

00201/4093

Schering Plough Ltd

Coprin

Product shelf-life extended

01088/2004

POM

00715/4064

The Bob Martin Co

Bob Martin Dual Wormer Tablets for Dogs

MA Holder name changed to: Bob Martin (UK) Ltd

01345/2004

GSL

00715/4065

The Bob Martin Co

Bob Martin Dual Wormer for Cats

MA Holder name changed to: Bob Martin (UK) Ltd

01348/2004

GSL

11810/4002

Tulivin Laboratories Ltd

Trioxyl La

Indication removed for use in cattle and sheep

01533/2004

POM

08007/4023

Vetoquinol (uk) Ltd

Trimediazine 15 Premix

MA Holder address changed to: Vetoquinol House, Great Slade, Buckingham Industrial Park, Buckingham MK18 1PA

01453/2004

MFS

08007/4067

Vetoquinol (uk) Ltd

Epiphen Tablets 30mg

MA Holder address changed to: Vetoquinol House, Great Slade, Buckingham Industrial Park, Buckingham MK18 1PA

01395/2004

POM

08007/4113

Vetoquinol (uk) Ltd

Clavaseptin 50mg Palatable Tablets

MA Holder address changed to: Vetoquinol House, Great Slade, Buckingham Industrial Park, Buckingham MK18 1PA

01408/2004

POM

08007/4081

Vetoquinol (uk) Ltd

Epiphen Solution

MA Holder address changed to: Vetoquinol House, Great Slade, Buckingham Industrial Park, Buckingham MK18 1PA

01441/2004

POM

16971/4004

Virbac De Portugal Laboratorios Lda

Equimax

Additional secondary pack sizes of 2 & 40 syringes

01256/2004

PML

05653/4111

Virbac De Portugal Laboratorios Lda

Pulmodox Oral Paste for Large Sized Dogs

Change to packaging material

01146/2002

POM

05653/4110

Virbac De Portugal Laboratorios Lda

Pulmodox Oral Paste for Medium Sized Dogs

Change to packaging material

01147/2002

POM

05653/4109

Virbac De Portugal Laboratorios Lda

Pulmodox Oral Paste for Small Dogs

Change to packaging material

01148/2002

POM

05653/4111

Virbac De Portugal Laboratorios Lda

Pulmodox Oral Paste for Large sized Dogs

Change to packaging material

01160/2004

POM

05653/4109

Virbac De Portugal Laboratorios Lda

Pulmodox Oral Paste for Small Dogs

Change to packaging material

01156/2004

POM

05653/4003

Virbac De Portugal Laboratorios Lda

Otello Insecticidal Collar for Dogs

Product name changed to Canac Dog Flea and Tick Collar

01375/2004

GSL