Veterinary 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 SI 1994/3142

From 26th August 2003 to 5th December 2003

ProductCompany NameProduct NameVariations GrantedApplicationLegal Category
Licence NumberNumber
04055/4040Ace Chemicals LtdIodine GlycerineAddition of coloured packs1995/1998GSL
Teat Dip Rtu
04055/4035Ace Chemicals LtdIodine LanolinAddition of coloured packs1996/1998GSL
Glycerine
Concentrate
04055/4037Ace Chemicals LtdMastexAddition of coloured packs1997/1998GSL
04055/4033Ace Chemicals LtdTeat GuardName of product changed00720/2000GSL
to Ruby Teatguard
04055/4035Ace Chemicals LtdIodine LanolinName of product changed00718/2000GSL
Glycerine Teat Dipto Gold Teat Dip Concentrate
Concentrate
01808/4007Agroserve LtdPostgardAddition of teat spraying00531/2003GSL
as a method of administration
04964/4013AquacultureAquavac FNM PlusExtension of Shelf Life00075/2003POM
Vaccines LtdVaccine
00010/4075Bayer (UK) LtdBaytril 2.5%MA/Holder Address changed to01067/2003POM
InjectionBayer PLC Animal Health
Division, Bayer House, Strawbury
Hill, Newbury, Berks RG1 1JA
00010/4085Bayer (UK) LtdHyonateMA/Holder Address changed to00739/2003POM
Bayer PLC Animal Health
Division, Bayer House, Strawbury
Hill, Newbury, Berks RG1 1JA
00010/4074Bayer (UK) LtdDrontal Plus TabletsMA/Holder Address changed to00623/2003PML
Bayer PLC Animal Health
Division, Bayer House, Strawbury
Hill, Newbury, Berks RG1 1JA
00010/4081Bayer (UK) LtdBaytril Tablets 15mgProduct Name changed to00724/2003POM
Baytril Flavour Tablets
00010/4083Bayer (UK) LtdBaytril TabletsProduct Name changed to00727/2003POM
150mgBaytril Flavour Tablets 150mg
00010/4082Bayer (UK) LtdBaytril Tablets 50mgProduct Name changed to00730/2003POM
Baytril Flavour Tablets 50mg
04895/4003Bayer AgAdvantage 40Address of Distributor changed00741/2003POM
For Catsto Bayer PLC, Animal Health
Division, Bayer House, Strawbury
Hill, Newbury, Berks RG1 1JA
04895/4002Bayer AgAdvantage 40Address of Distributor changed00742/2003POM
For Dogsto Bayer PLC, Animal Health
Division, Bayer House, Strawbury
Hill, Newbury, Berks RG1 1JA
04895/4006Bayer AgAdvantage 80Address of Distributor changed00743/2003POM
For Catsto Bayer PLC, Animal Health
Division, Bayer House, Strawbury
Hill, Newbury, Berks RG1 1JA
04895/4004Bayer AgAdvantage 100Address of Distributor changed00744/2003POM
For Dogsto Bayer PLC, Animal Health
Division, Bayer House, Strawbury
Hill, Newbury, Berks RG1 1JA
04895/4007Bayer AgAdvantage 400Address of Distributor changed00735/2003POM
For Dogsto Bayer PLC, Animal Health
Division, Bayer House, Strawbury
Hill, Newbury, Berks RG1 1JA
04895/4005Bayer AgAdvantage 250 forAddress of Distributor changed00745/2003POM
For Dogsto Bayer PLC, Animal Health
Division, Bayer House, Strawbury
Hill, Newbury, Berks RG1 1JA
00010/4121Bayer PlcTop Drop forMA/Holder Address changed to01054/2003POM
Large CatsBayer PLC, Animal Health
Division, Bayer House, Strawbury
Hill, Newbury, Berks RG1 1JA
00010/4124Bayer PlcTop Drop forMA/Holder Address changed to01055/2003POM
Large DogsBayer PLC, Animal Health
Division, Bayer House, Strawbury
Hill, Newbury, Berks RG1 1JA
00010/4123Bayer PlcTop Drop forMA/Holder Address changed to01056/2003POM
Medium DogsBayer PLC, Animal Health
Division, Bayer House, Strawbury
Hill, Newbury, Berks RG1 1JA
00010/4120Bayer PlcTop Drop forMA/Holder Address changed to01057/2003POM
Small CatsBayer PLC, Animal Health
Division, Bayer House, Strawbury
Hill, Newbury, Berks RG1 1JA
00010/4122Bayer PlcTop Drop forMA/Holder Address changed to01058/2003POM
Small DogsBayer PLC, Animal Health
Division, Bayer House, Strawbury
Hill, Newbury, Berks RG1 1JA
00010/4119Bayer PlcBaymec Pour-on forMA/Holder Address changed to00935/2003PML
CattleBayer PLC, Animal Health
Division, Bayer House, Strawbury
Hill, Newbury, Berks RG1 1JA
00010/4116Bayer PlcAdvantage for SmallMA/Holder Address changed to00616/2003POM
Cats and Small DogsBayer PLC, Animal Health
Division, Bayer House, Strawbury
Hill, Newbury, Berks RG1 1JA
00010/4117Bayer PlcAdvantage for SmallMA/Holder Address changed to00617/2003POM
Cats, Small DogsBayer PLC, Animal Health
and Pet RabbitsDivision, Bayer House, Strawbury
Hill, Newbury, Berks RG1 1JA
00010/4126Bayer PlcDrontal Plus XLMA/Holder Address changed to00624/2003PML
TabletsBayer PLC, Animal Health
Division, Bayer House, Strawbury
Hill, Newbury, Berks RG1 1JA
00010/4113Bayer PlcBayer DogMA/Holder Address changed to00417/2003PML
Wormer TabletsBayer PLC, Animal Health
Division, Bayer House, Strawbury
Hill, Newbury, Berks RG1 1JA
00010/4076Bayer PlcBaytril 5% InjectionMA/Holder Address changed to01068/2003POM
Bayer PLC, Animal Health
Division, Bayer House, Strawbury
Hill, Newbury, Berks RG1 1JA
00010/4115Bayer PlcMulti-Worm TabletsMA/Holder Address changed to00926/2003PML
for dogsBayer PLC, Animal Health
Division, Bayer House, Strawbury
Hill, Newbury, Berks RG1 1JA
00010/4110Bayer PlcFleegard 4 for DogsMA/Holder Address changed to00928/2003POM
Bayer PLC, Animal Health
Division, Bayer House, Strawbury
Hill, Newbury, Berks RG1 1JA
00010/4091Bayer PlcBolfo Flea SprayMA/Holder Address changed to00933/2003GSL
Bayer PLC, Animal Health
Division, Bayer House, Strawbury
Hill, Newbury, Berks RG1 1JA
00010/4104Bayer PlcQuazitel 2.5%MA/Holder Address changed to00925/2003PML
SuspensionBayer PLC, Animal Health
Division, Bayer House, Strawbury
Hill, Newbury, Berks RG1 1JA
00010/4109Bayer PlcFleegard 8 for CatsMA/Holder Address changed to00927/2003POM
Bayer PLC, Animal Health
Division, Bayer House, Strawbury
Hill, Newbury, Berks RG1 1JA
00010/4108Bayer PlcFleegard 4 for CatsMA/Holder Address changed to00929/2003POM
Bayer PLC, Animal Health
Division, Bayer House, Strawbury
Hill, Newbury, Berks RG1 1JA
00010/4112Bayer PlcFleegard 20MA/Holder Address changed to00930/2003POM
for DogsBayer PLC, Animal Health
Division, Bayer House, Strawbury
Hill, Newbury, Berks RG1 1JA
00010/4111Bayer PlcFleegard 10MA/Holder Address changed to00931/2003POM
for DogsBayer PLC, Animal Health
Division, Bayer House, Strawbury
Hill, Newbury, Berks RG1 1JA
00010/4099Bayer PlcDroncit PillsMA/Holder Address changed to00932/2003GSL
Bayer PLC, Animal Health
Division, Bayer House, Strawbury
Hill, Newbury, Berks RG1 1JA
00010/4105Bayer PlcDroncit Spot OnLegal Category changed00532/2003POM
from POM to GSL
00010/4118Bayer PlcEquitape HorseMA/Holder Address changed to00737/2003PML
Paste (DroncitBayer PLC, Animal Health
Horse Paste 9%)Division, Bayer House, Strawbury
Hill, Newbury, Berks RG1 1JA
00010/4098Bayer PlcDroncit InjectableMA/Holder Address changed to00738/2003POM
Bayer PLC, Animal Health
Division, Bayer House, Strawbury
Hill, Newbury, Berks RG1 1JA
00010/4093Bayer PlcRompun 2%MA/Holder Address changed to00740/2003POM
SolutionBayer PLC, Animal Health
Division, Bayer House, Strawbury
Hill, Newbury, Berks RG1 1JA
00010/4094Bayer UK LtdDrontal Cat TabletsMA/Holder Address changed to00622/2003PML
Bayer PLC, Animal Health
Division, Bayer House, Strawbury
Hill, Newbury, Berks RG1 1JA
00010/4079Bayer UK LtdBaytril Piglet DoserMA/Holder Address changed to00618/2003POM
Bayer PLC, Animal Health
Division, Bayer House, Strawbury
Hill, Newbury, Berks RG1 1JA
00010/4101Bayer UK LtdBinixin InjectionMA/Holder Address changed to00619/2003POM
Bayer PLC, Animal Health
Division, Bayer House, Strawbury
Hill, Newbury, Berks RG1 1JA
00010/4105Bayer UK LtdDroncit Spot OnMA/Holder Address changed to00620/2003POM
Bayer PLC, Animal Health
Division, Bayer House, Strawbury
Hill, Newbury, Berks RG1 1JA
00010/4097Bayer UK LtdDroncit TabletsMA/Holder Address changed to00621/2003GSL
Bayer PLC, Animal Health
Division, Bayer House, Strawbury
Hill, Newbury, Berks RG1 1JA
00010/4080Bayer UK LtdBaytril 10%MA/Holder Address changed to01065/2003POM
Injection SolutionBayer PLC, Animal Health
Division, Bayer House, Strawbury
Hill, Newbury, Berks RG1 1JA
00010/4077Bayer UK LtdBaytril 10% OralMA/Holder Address changed to01066/2003POM
SolutionBayer PLC, Animal Health
Division, Bayer House, Strawbury
Hill, Newbury, Berks RG1 1JA
00010/4105Bayer UK LtdDrocit Spot-OnLegal category changed from00532/2003GSL
POM to GSL
00015/4066Boehringer IngelheimVetmedin 1. 25mgChange of Storage Conditions01024/2003POM
LtdCapsules
00015/4049Boehringer IngelheimVetmedin 2.5 mgChange of Storage Conditions01025/2003POM
LtdCapsules
00015/4050Boehringer IngelheimVetmedin 5mgChange of Storage Conditions01026/2003POM
LtdCapsules
11990/4018Chanelle AnimalClinacin 75mgShelf Life Extended00747/2003POM
Health LtdTablets
11990/4025Chanelle AnimalClinacin 25mgShelf Life Extended00748/2003POM
Health LtdTablets
11990/4026Chanelle AnimalClinacin 150mgShelf Life Extended00749/2003POM
Health LtdTablets
11990/4002Chanelle AnimalChanaverm 7.5%Withdrawal Period (Increase)00787/2003PML
Health Ltd
15985/4009Diverseylever LtdDeosan TeatcareMA/Holder Name changed to00862/2003GSL
PlusJohnson Diversey Ltd
15985/4012Diverseylever LtdDeosan SuperMA/Holder Name changed to00863/2003GSL
Ex-CelJohnson Diversey Ltd
15985/4013Diverseylever LtdStar Ready DipMA/Holder Name changed to00432/2003GSL
Johnson Diversey Ltd
15985/4014Diverseylever LtdDeosan ThixodipMA/Holder Name changed to00433/2003GSL
Johnson Diversey Ltd
16849/4001Eurovet AnimalSedaxylanAdditional Distributor01059/2003POM
Health Bv
03940/4096Evans VanodineHibitex Ready ToOther (See Detailed Reason00954/2003GSL
International PlcUse Teat Spray Dipin Notes)
01596/4297Fort DodgeCydectin 1%Withdrawal Period Increased00061/2002PML
Animal HealthInjectable Solution
for Cattle
01596/4301Fort DodgeDysect SheepAdditional Pack Size00750/2003PML
Animal HealthPour-On
05928/4004Forum Products LtdCefalexin TabletsProduct Name changed from01011/2003POM
250mgKefloril 250mg tablets
05928/4004Forum Products LtdCefalexin TabletsAdditional Pack Size01015/2003POM
250mg
14153/4001Hypred SaIodyproMA/Holder Name changed to00538/2003GSL
Johnson Diversey Ltd
14153/4002Hypred SaPropisdermMA/Holder Name changed to00539/2003GSL
Johnson Diversey Ltd
14153/4004Hypred SaHexiprotect WsMA/Holder Name changed to00540/2003GSL
Johnson Diversey Ltd
14153/4003Hypred SaIoprotect WsMA/Holder Name changed to00541/2003GSL
Johnson Diversey Ltd
14153/4000Hypred SaTrempexMA/Holder Name changed to00537/2003GSL
Johnson Diversey Ltd
01708/4476Intervet UK LtdEryvacAdditional Pack Type00811/2003PML
01708/4323Intervet UK LtdDexadresonShelf Life Extended00566/2003POM
01708/4489Intervet UK LtdNobilis ParamyxoShelf Life Extended00625/2003POM
P201
01708/4381Intervet UK LtdCanigen DhppiTo Extend Duration of Immunity00326/2003POM
01708/4360Intervet UK LtdNobivac Lepto 2Safety Warnings change to00222/2001POM
Minimum Age of vaccination
to 6 weeks
01708/4419Intervet UK LtdBorgal 24%Shelf Life Extended00448/2003POM
Solution
01759/4068Johnson’s VeterinaryJohnsons InsecticidalAdditional Safety Warnings00640/2003GSL
Products LtdFlea And Tick Drops
01759/4067Johnson’s VeterinaryJohnson’s flea &Additional Safety Warnings00641/2003GSL
Products Ltdtick drops for puppies
and small dogs
08327/4207Merial AnimalAvinewChange of MA/Holder Address01162/2003POM
Health Ltdin France
08327/4208Merial AnimalGallivac SEChange of MA/Holder Address01163/2003POM
Health Ltdin France
08327/4204Merial AnimalProgressisChange of MA/Holder Address01166/2003POM
Health Ltdin France
08327/4189Merial AnimalHyorespChange of MA/Holder Address01164/2003POM
Health Ltdin France
08327/4173Merial AnimalPastobovChange of MA/Holder Address01165/2003POM
Health Ltdin France
02000/4040Norbrook LaboratoriesNoroclox DcAdditional Pack Type00839/2003POM
Limited
02000/4141Norbrook LaboratoriesAmoxycare LaWithdrawal Period Increased00472/2003POM
LimitedInjection
02000/4141Norbrook LaboratoriesAmoxycare LaWithdrawal Period Increased00473/2003POM
LimitedInjection
02000/4148Norbrook LaboratoriesTrimacare BolusWithdrawal Period Decreased00564/2003POM
Limited
12501/4118Novartis AnimalRobustShelf Life Extended00634/2003PML
Health UK Ltd
12501/4018Novartis AnimalFasinex 5%Additional Safety Warnings01034/2003PML
Health UK Ltd
12501/4150Novartis AnimalJohnson’s 4FleasRemoval of Indications01193/2003GSL
Health UK LtdTablets for Small
Dogs and Puppies,
Cats and Kittens
12501/4151Novartis AnimalJohnson’s 4FleasRemoval of Indications01194/2003GSL
Health UK Ltd11.4mg Tablets
for Cats and Kittens,
Small Dogs and Puppies
12501/4059Novartis AnimalCapstar 11.4mgLegal category changed from00952/2002GSL
Health UK LtdTabletsPOM to GSL
12501/4060Novartis AnimalCapstar 57mg TabletsLegal category changed from00951/2002GSL
Health UK LtdPOM to GSL
18343/4000Novartis AnimalPycezeAdditional Pack Size00405/2002POM
Vaccines Ltd
00057/4206Pfizer Ltd & CentralStellamune OnceChanges to Minimum Age and01302/2002POM
Research Divisionassociated Duration of Immunity
04188/4026Pharmacia & UpjohnNeomycin PremixAdditional Distributor00602/2003MFS
Animal Health Ltd
04188/4051Pharmacia & UpjohnTetra DeltaAdditional Distributor00608/2003POM
Animal Health Ltd
04188/4025Pharmacia & UpjohnUniprim for HorsesAdditional Distributor00611/2003POM
Animal Health Ltd
04188/4064Pharmacia & UpjohnVeramix SheepAdditional Distributor00612/2003POM
Animal Health LtdSponge
04188/4045Pharmacia AnimalDepo-Medrone VAdditional Distributor00576/2003POM
Health Ltd
04188/4076Pharmacia AnimalKaobiotic TabletsAdditional Distributor00582/2003POM
Health Ltd
04188/4074Pharmacia AnimalKaogel VPAdditional Distributor00583/2003GSL
Health Ltd
04188/4073Pharmacia AnimalLincocin Forte SAdditional Distributor00584/2003POM
Health Ltd
04188/4037Pharmacia AnimalLincocin PremixAdditional Distributor00585/2003MFS
Health Ltd
04188/4053Pharmacia AnimalMedrone VAdditional Distributor00596/2003POM
Health LtdTablets 2mg
04188/4061Pharmacia AnimalLincocin SolubleAdditional Distributor00586/2003POM
Health LtdPowder
04188/4070Pharmacia AnimalLincocin SterileAdditional Distributor00587/2003POM
Health LtdSolution
04188/4042Pharmacia AnimalLincocin TabletsAdditional Distributor00588/2003POM
Health Ltd100mg
04188/4038Pharmacia AnimalLincocin TabletsAdditional Distributor00589/2003POM
Health Ltd500mg
04188/4058Pharmacia AnimalLincomix 800Additional Distributor00591/2003MFS
Health Ltd
04188/4039Pharmacia AnimalLinco Spectin 100Additional Distributor00592/2003POM
Health LtdSoluble Powder
04188/4055Pharmacia AnimalLinco SpectinAdditional Distributor00593/2003MFS
Health LtdPremix
04188/4056Pharmacia AnimalLinco SpectinAdditional Distributor00594/2003MFS
Health LtdPremix 880
04188/4069Pharmacia AnimalLutalyseAdditional Distributor00595/2003POM
Health Ltd
04188/4054Pharmacia AnimalMedrone VAdditional Distributor00597/2003POM
Health LtdTablets 4mg
04188/4024Pharmacia AnimalMetronex for HorsesAdditional Distributor00599/2003POM
Health Ltd
04188/4078Pharmacia AnimalPancrex Vet PowderAdditional Distributor00603/2003GSL
Health Ltd
04188/4043Pharmacia AnimalPromone E 50mg MlAdditional Distributor00604/2003POM
Health Ltd
04188/4059Pharmacia AnimalSolu Medrone VAdditional Distributor00605/2003POM
Health Ltd(125mg)
04188/4031Pharmacia AnimalSolu Medrone VAdditional Distributor00606/2003POM
Health Ltd(500mg)
04188/4068Pharmacia AnimalTetraclox Dry CowAdditional Distributor00607/2003POM
Health LtdXtra
04188/4028Pharmacia AnimalTetramin 200 PowderAdditional Distributor00609/2003MFS
Health Ltd
04188/4029Pharmacia AnimalUniprim 150 PowderAdditional Distributor00610/2003MFS
Health Ltd
04188/4067Pharmacia AnimalVetalar VAdditional Distributor00613/2003POM
Health Ltd
04188/4044Pharmacia AnimalWater for InjectionsAdditional Distributor00614/2003POM
Health Ltd
04188/4052Pharmacia AnimalNeobiotic SolubleAdditional Distributor00601/2003POM
Health LtdPowder 70%
04188/4035Pharmacia AnimalAntirobe CapsulesAdditional Distributor00570/2003POM
Health Ltd25mg
04188/4036Pharmacia AnimalAntirobe CapsulesAdditional Distributor00571/2003POM
Health Ltd75mg
04188/4077Pharmacia AnimalAntirobe CapsulesAdditional Distributor00573/2003POM
Health Ltd300mg
04188/4071Pharmacia AnimalEnviracorAdditional Distributor00577/2003POM
Health Ltd
04188/4049Pharmacia AnimalExcenel SterileAdditional Distributor00578/2003POM
Health LtdPowder 1g
04188/4075Pharmacia AnimalFostim 6000Additional Distributor00580/2003POM
Health Ltd
01272/4001Robinsons & Sons LtdAnimalintexMA/Holder Address & Name00631/2003GSL
changed to Robinson Healthcare
Ltd, Lawn Road Industrial Estate,
Carlton-in-Lindrick,
Worksop S81 9LB
01272/4002RobinsonsAnimalintex HoofMA/Holder Address & Name00630/2003GSL
Healthcare LtdTreatmentchanged to Robinson Healthcare
Ltd, Lawn Road Industrial Estate,
Carlton-in-Lindrick,
Worksop S81 9LB
00201/4009Schering Plough LtdFinadyne SolutionWithdrawal Period Increased00786/2003POM
00201/4085Schering Plough LtdSavlon VeterinaryProduct Name changed to00495/2003GSL
ConcentrateSavlon Veterinary Antiseptic
Concentrate
00201/4174Schering Plough LtdCovexin 10Shelf Life extended00547/2003POM
02548/4022Sinclair Animal &Friends Cat FleaProduct Name changed to00988/2003GSL
Household Care LtdCollarCanac Cat Flea Collar
00715/4054The Bob Martin CoBob Martin DogUser Safety Warnings00946/2003GSL
Spot On
17381/4004Vericore LtdExcisMA/Holder changed to Novartis01083/2003POM
08007/4017Vetoquinol (UK) LtdTrimedoxine 4sWithdrawal Period Decreased00678/2003POM
08007/4064Vetoquinol (UK) LtdTrimediazine BmpWithdrawal Period Decreased00628/2003MFS
08007/4107Vetoquinol (UK) LtdPrilium 150mgShelf Life After Reconstitution00181/2003POM
Powder for OralExtended
Solution
16971/4004Virbac De PortugalEQUIMAXAdditional Pack Size00316/2003PML
Laboratorios Lda