ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS · gallivac hvt ibd 12 particulars to appear on the...

Gallivac HVT IBD 1

ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS

Gallivac HVT IBD 2

1. NAME OF THE IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCT

GALLIVAC HVT IBD

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each dose of vaccine contains:Suspension:. Live vHVT013-69 recombinant virus, at least .........................................................3.0 log10 PFU. Excipient........................................................................................................................... qs 1 doseDiluent:. Diluent ................................................................................................................................... 0.2 ml

3. PHARMACEUTICAL FORM

Frozen suspension and diluent for injection.

4. IMMUNOLOGICAL PROPERTIES

Live recombinant vaccine against Infectious Bursal Disease and Marek’s Disease.

The vaccine strain is a recombinant Herpesvirus of turkeys (HVT) expressing the protective antigen(VP2) of the Infectious Bursal Disease Virus (IBDV) strain Faragher 52/70.The vaccine induces an active immunity and a serological response against Infectious Bursal Diseaseand Marek’s Disease in chickens.

5. CLINICAL PARTICULARS

5.1 Target species

Day-old chickens.

5.2 Indications for use, specifying the target species

For active immunisation of day-old chickens:

� To prevent mortality and to reduce clinical signs and lesions of Infectious Bursal disease.

The onset of protection is from 2 weeks and the protection extends to 9 weeks.

� To reduce mortality, clinical signs and lesions of Marek’s disease.

The onset of protection is from 4 days. A single vaccination is sufficient to provide protectionduring the risk period.

5.3 Contraindications

Vaccinate only healthy birds.Do not use in birds in lay and breeding birds.

Gallivac HVT IBD 3

5.4 Undesirable effects

None known.

5.5 Special precaution(s) for use

Apply the usual aseptic precautions to all administration procedures.As a live vaccine, the vaccine strain is excreted from vaccinated birds and may spread to turkeys.Safety and reversion to virulence trials have shown that the strain is safe for turkeys. However,precautionary measures have to be followed in order to avoid direct or indirect contact betweenvaccinated chickens and turkeys.

5.6 Use in breeder birds

Do not use in breeding birds and birds in lay.

5.7 Interaction with other veterinary medicinal products and other forms of interaction

No information is available on the safety and efficacy from the concurrent use with any othervaccine, except Merial attenuated vaccines against Marek’s disease, Newcastle disease andInfectious bronchitis. It is therefore recommended that no other vaccine than these should beadministered within 14 days after vaccination with the product.

5.8 Posology and method of administration

5.8.1 Reconstitution of the vaccine

. Wear protective gloves and spectacles during the ampoule thawing and openingoperations.

. Remove from the liquid nitrogen container only those ampoules which are to be usedimmediately.

. Thaw the contents of the ampoules rapidly by agitation in water at 25-30°C. Proceedimmediately to next step.

. As soon as they are thawed, open ampoules holding them at arm’s length in order toprevent any risk of injury should an ampoule break.

. Once the ampoule is opened, draw up the contents into a 5 ml sterile syringe.

. Transfer the suspension into the diluent.

. Draw up 2 ml of the contents of the diluent into the syringe.

. Rinse the ampoule with these 2 ml and then transfer the rinsing liquid into the diluent.Repeat the rinsing operation once or twice.

. The diluted vaccine prepared as described is mixed by gentle agitation so as to beready for use. It should be used immediately after the preparation (all of the dilutedvaccine should be used up within one hour). This is why the vaccine suspensionshould only be prepared as and when required.

5.8.2 Posology

One single injection of 0.2 ml per chicken at the age of one day.

5.8.3 Method of administration

The vaccine must be administered by subcutaneous route.

5.9 Overdose (signs, emergency procedures, antidotes)

None known.

Gallivac HVT IBD 4

5.10 Special warnings for each target species

None.

5.11 Withdrawal period

Zero days.

5.12 Special precautions to be taken by the person administering the product to animals

. Wear protective gloves and spectacles during the ampoule thawing and opening operations.

. Open ampoules holding them at arm’s length in order to prevent any risk of injury should anampoule break.

6. PHARMACEUTICAL PARTICULARS

6.1 Incompatibilities

Use sterile and antiseptic-free and/or disinfectant-free equipment for injections purposes.Do not mix with any other product except the diluent supplied for use with the product.

6.2 Shelf-life

Shelf-life of the non-reconstituted vaccine: 36 months at –196°CShelf-life of the reconstituted vaccine: up to 2 hours at a temperature lower than 25°C.Shelf-life of the diluent in polypropylene bottles: 12 months at a temperature lower than 30°C.Shelf-life of the diluent in polyvinylchloride bags: 12 months at a temperature lower than 30°C.

6.3 Special precautions for storage

Store the vaccine in liquid nitrogen.Store the reconstituted vaccine at a temperature lower than 25°C.Store the diluent at a temperature lower than 30°C, protected from light. Avoid freezing andexcessive temperatures.

6.4 Nature and contents of container

- (glass) ampoule of 1,000 doses of vaccine, 5-ampoule carrier.Ampoule carriers are stored in canister, and in liquid nitrogen containers.

- (polypropylene) bottle of 200 ml of diluent.- (polypropylene) bottle of 200 ml of diluent, box of 10 bottles.- (polyvinylchloride) bag of 200 ml of diluent, box of 36 bags.- (polyvinylchloride) bag of 400 ml of diluent, box of 24 bags.- (polyvinylchloride) bag of 600 ml of diluent, box of 20 bags.- (polyvinylchloride) bag of 800 ml of diluent, box of 16 bags.- (polyvinylchloride) bag of 1000 ml of diluent, box of 8 bags.- (polyvinylchloride) bag of 1200 ml of diluent, box of 8 bags.- (polyvinylchloride) bag of 1400 ml of diluent, box of 8 bags.- (polyvinylchloride) bag of 1600 ml of diluent, box of 8 bags.- (polyvinylchloride) bag of 1800 ml of diluent, box of 8 bags.- (polyvinylchloride) bag of 2400 ml of diluent, box of 6 bags.

Gallivac HVT IBD 5

6.5 Special precautions for the disposal of unused product or waste material, if any

Discard any ampoules that have been accidentally thawed. Do not re-freeze under any circumstances.Do not re-use opened containers of diluted vaccine.Destroy unused vaccine contents.Empty containers or contaminated equipment should be disposed of safely by boiling, incineration orby immersion in an appropriate disinfectant approved by competent authorities.

7. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

MERIAL17, rue Bourgelat69002 LYON, FRANCE

NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

DATE OF REVISION OF THE TEXT

Gallivac HVT IBD 6

ANNEX II

A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) ANDMANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FORBATCH RELEASE

B. CONDITIONS OF THE MARKETING AUTHORISATION INCLUDINGRESTRICTIONS REGARDING SUPPLY AND USE

C. PROHIBITION OF SALE, SUPPLY AND/OR USE

D. STATEMENT OF THE MRLs

Gallivac HVT IBD 7

A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE ANDMANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCHRELEASE

Name and address of the manufacturers of the biological active substance(s)

MERIAL,Laboratory of Lyon Gerland254, rue Marcel Mériux69007 LyonFrance

Name and address of the manufacturer(s) responsible for batch release

MERIAL1 chemin de Cruzols69595 LentillyFrance

The Manufacturing Authorisation granted by French Ministerial Decision V 1295/92/2 was presented.GMP status was confirmed by the French Authorities during an inspection in 1999.

The Baxter (diluent) site in the USA was inspected in May 2001 and found to be GMP compliant.

B. CONDITIONS OF THE MARKETING AUTHORISATION INCLUDINGRESTRICTIONS REGARDING SUPPLY AND USE

Veterinary medicinal product subject to prescription.

C. PROHIBITION OF SALE, SUPPLY AND/OR USE

According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council,Member States prohibit or may prohibit the import, sale, supply and/or use of the veterinary medicinalproduct on the whole or part of their territory if it is established that:

a) the administration of the veterinary medicinal product to animals will interfere with theimplementation of national programmes for the diagnosis, control and eradication of animaldiseases, or will cause difficulties in certifying the absence of contamination in live animals orin foodstuffs or other products obtained from treated animals.

b) the disease to which the veterinary medicinal product is intended to confer immunity is largelyabsent from the territory.

Gallivac HVT IBD 8

D. STATEMENT OF THE MRLs

Pharmacologically activesubstance

Animal Species Other provisions

Dimethyl sulfoxide Annex II: All food producingspecies

Sodium hydrogen carbonate Annex II (E500ii)Hydrochloric acid Annex II: All food producing

species (For use as excipient)Casein hydrolysate Peptides and proteins naturally

occuring - not within the scopeof Council Regulation 2377/90.

Dipotassium phosphate Annex II (E340ii)Potassium dihydrogenphosphate (momopotassiumphosphate)

Annex II (E340i)

Sodium hydroxide Annex II(E 524)Water for injections Not within the scope of Council

Regulation 2377/90

For the following substances, the data provided by the Applicant were assessed and the substancesconsidered not to be pharmacologically active at the doses used;

F10 HAM Medium199 mediumPhenol redGentamicin

Gallivac HVT IBD 9

ANNEX III

LABELLING AND PACKAGE INSERT

Gallivac HVT IBD 10

A. LABELLING

Gallivac HVT IBD 11

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATEPACKAGING UNITSAMPOULE 1000 doses

1 NAME OF THE VETERINARY MEDICINAL PRODUCT

GALLIVAC HVT IBD

2 CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES

1000 doses

3 ROUTE(S) OF ADMINISTRATION

SC Route

4 BATCH NUMBER

Batch

5 EXPIRY DATE

EXP

6 THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only

Gallivac HVT IBD 12

PARTICULARS TO APPEAR ON THE IMMEDIATEPACKAGING UNITS

STERILE DILUENT (200 ml)


STERILE DILUENT


200 ml

3 BATCH NUMBER

Batch

4 EXPIRY DATE

EXP

5 THE WORDS "FOR ANIMAL TREATMENT ONLY" (13 LANGUAGES)

Til dyr.Uitsluitend voor diergeneeskundig gebruik.For animal treatment only.Eläimille.A usage vétérinaire.Für Tiere.A�o��o�� x� Einungis ætlað dýrum.Solamento per uso veterinario.Exclusivamente para uso veterinário.Únicamente para uso veterinario.För djur.

6 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THEMANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA

Marketing authorisation holderMERIAL17 rue Bourgelat 69002 Lyon, FRANCE

Manufacturing authorisation holder responsible for batch releaseMERIAL1 chemin de Cruzols69595 LentillyFrance

7 NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTSEU/0/00/000/000

Gallivac HVT IBD 13

PARTICULARS TO APPEAR ON THE OUTER PACKAGESTERILE DILUENT (10x200 ml)


STERILE DILUENT


10 bottles of 200 ml

3 TARGET SPECIES

Chickens.

4 METHOD AND ROUTE(S) OF ADMINISTRATION

Refer to the package insert enclosed in the vaccine vial.

5 WITHDRAWAL PERIOD

Zero days.

6 SPECIAL WARNING(S)

Use immediately after preparation.Do not use if cloudy.

7 EXPIRY DATE

EXP

8 SPECIAL STORAGE CONDITIONS

Store at a temperature lower than 30°C. Avoid freezing or excessive temperatures.

9 THE WORDS "FOR ANIMAL TREATMENT ONLY"

For animal treatment only.

10 THE WORDS "KEEP OUT OF REACH AND SIGHT OF CHILDREN"

Keep out of reach and sight of children.

Gallivac HVT IBD 14

11 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THEMANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA

Marketing authorisation holderMERIAL17 rue Bourgelat 69002 Lyon, FRANCE


12 NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS

13 BATCH NUMBER

Batch

14 CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE


Gallivac HVT IBD 15

B. PACKAGE INSERT

Gallivac HVT IBD 16

PACKAGE INSERT(VACCINE SUSPENSION)


GALLIVAC HVT IBDLive recombinant vaccine against Infectious Bursal Disease and Marek's Disease.

2 STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S)

Each dose of vaccine contains:Suspension:. Live vHVT013-69 recombinant virus, at least .........................................................3.0 log10 PFU. Excipient........................................................................................................................... qs 1 doseDiluent:

Diluent ................................................................................................................................... 0.2 ml

3 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THEMANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA, IFDIFFERENT

Marketing authorisation holderMERIAL17, rue Bourgelat, 69002 LYON, FRANCE


4 TARGET SPECIES

Day-old chickens.

5 INDICATION(S)

For active immunisation of day-old chickens:

� To prevent mortality and to reduce clinical signs and lesions of Infectious Bursal disease.

The onset of protection is from 2 weeks and the protection extends to 9 weeks.

� To reduce mortality, clinical signs and lesions of Marek’s disease.

The onset of protection is from 4 days. A single vaccination is sufficient to provide protectionduring the risk period.

6 DOSAGE FOR EACH SPECIES

One single injection of 0.2 ml per chicken at the age of one day.

Gallivac HVT IBD 17


Subcutaneous route.

8 ADVICE ON CORRECT ADMINISTRATION

. Wear protective gloves and spectacles during the ampoule thawing and opening operations.

. Remove from the liquid nitrogen container only those ampoules which are to be usedimmediately.

. Thaw rapidly the contents of the ampoules by agitation in water at 25-30°C. Proceedimmediately to next step.

. As soon as they are thawed, open ampoules holding them at arm’s length in order to preventany risk of injury should an ampoule break.

. Once the ampoule is opened, draw up the contents into a 5 ml sterile syringe.

. Transfer the suspension into the diluent.

. Draw up 2 ml of the contents of the diluent into the syringe.

. Rinse the ampoule with these 2 ml and then transfer the rinsing liquid into the diluent. Repeatthe rinsing operation once or twice.

. The diluted vaccine prepared as described is mixed by gentle agitation so as to be ready foruse. It should be used immediately after the preparation (all of the diluted vaccine should beused up within one hour). This is why the vaccine suspension should only be prepared as andwhen required.

9 CONTRAINDICATIONS

Vaccinate only healthy birds.Do not use in birds in lay and breeding birds.

10 UNDESIRABLE EFFECTS

None known.

11 WITHDRAWAL PERIOD

Zero days.

12 SPECIAL STORAGE PRECAUTIONS

Keep out of the reach and sight of children.Store the vaccine in liquid nitrogen.Do not use after the expiry date stated on the ampoule.

Gallivac HVT IBD 18


. Use sterile and antiseptic – and/or disinfectant free equipment for injections purposes.

. Do not mix with any other product except the diluent supplied for use with the product.

. As a live vaccine, the vaccine strain is excreted from vaccinated birds and may spread toturkeys. Safety and reversion to virulence trials have shown that the strain is safe for turkeys.However, precautionary measures have to be followed in order to avoid direct contact betweenvaccinated chickens and turkeys.. No information is available on the safety and efficacy from the concurrent use with any othervaccine, except Merial attenuated vaccines against Marek’s disease, Newcastle disease and Infectiousbronchitis. It is therefore recommended that no other vaccine than these should be administered within14 days after vaccination with the product.

14 SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCT ORWASTE MATERIALS DERIVED FROM SUCH VETERINARY MEDICINAL PRODUCTS

Discard any ampoules that have been accidentally thawed. Do not re-freeze under any circumstances.Do not re-use opened containers of diluted vaccine.Destroy unused vaccine contents.Empty containers or contaminated equipment should be disposed of safely, by boiling, incineration orimmersion in an appropriate disinfectant approved for use by the competent authorities.

15 DATE ON WHICH THE PACKAGE INSERT WAS LAST REVISED

16 OTHER INFORMATION


For any information about this veterinary medicinal product, please contact the local representative ofthe marketing authorisation holder.

België/Belgique/BelgienMERIAL BELGIUM S.A./N.V.Bd Sylvain Dupuislaan 243B-1070 Bruxelles – Brussel - BrüsselTél/Tel: + 32-(0) 2 529 49 00

Luxembourg/LuxemburgMERIAL BELGIUM S.A./N.V.Bd Sylvain Dupuislaan 243B-1070 Bruxelles - BrüsselBelgique - BelgienTél: + 32-2 529 49 00

DanmarkMERIAL NORDEN A/SMileparken 20EDK-2740 SkovlundeTlf: +45-44-54-00-40

NederlandMERIAL B.V.Bovenkerkerweg 6-8,NL-1185 XE AMSTELVEENTel: + 31-20 547 39 33

DeutschlandMERIAL GmbHAm Söldnermoos 6D-85399 HallbergmoosTel: + 49-811 9593 0

ÖsterreichRichter Pharma AGFeldgasse 19A-4600 WelsTel.: +43 7242 490 0

Gallivac HVT IBD 19

E��

AGROSEED A.E.Agricultural trading and manufacturing companyPAPADA 2 & MESOGEIVN, 115 25 AUHNATel : + 30-1.698 19 75

PortugalMERIAL PORTUGUESA – Saùde Animal, Lda.Av. Maria Lamas, Lote 19 – BL.A Piso 2Serra das MinasP-2635–432 Rio de MouroTel: + 351- 21 916 9340

EspañaMERIAL Laboratorios SAC/Tarragona n°161E-08014 BarcelonaTel: + 34-93 292 83 83

Suomi/FinlandVETER ABKlockarvägen 114S-15161 Södertälje –Ruotsi/SverigePuh/Tln: + 46- 8 554 203 60

FranceMERIAL11 avenue Albert EinsteinF-69100 Villeurbanne.Tél: + 33-(0) 4 72 72 30 00

SverigeVETER ABKlockarvägen 114S-15161 SödertäljeTln: + 46-(0) 8 554 203 60

IrelandMERIAL ANIMAL HEALTH LimitedPO Box 327,Sandringham House, Sandringham AvenueHarlow Business ParkHarlow, CM 19 5TG - UKTel: + 44-1279 775858

United KingdomMERIAL ANIMAL HEALTH LimitedPO Box 327,Sandringham House, Sandringham AvenueHarlow Business ParkHARLOW, CM 19 5TG - UKTel: + 44-(0)1279 775858

ItaliaMerial Italia S.p.A.Milanofiori - Strada 6 - Palazzo E 5IT - 20090 Assago (MI)Tel +39 02 577661

Gallivac HVT IBD 20

PACKAGE INSERT(STERILE DILUENT)


STERILE DILUENT

18 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THEMANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA, IFDIFFERENT

Marketing authorisation holderMERIAL17, rue Bourgelat69002 LYON, FRANCE


19 TARGET SPECIES

Chickens.


Refer to the package insert enclosed in the vaccine vial.

21 ADVICE ON CORRECT ADMINISTRATION

Freeze-dried vaccines:Refer to the package insert enclosed in the vaccine vial.

Frozen vaccines:. Wear protective gloves and spectacles during the ampoule thawing and opening operations.. Remove from the liquid nitrogen container only those ampoules which are to be used

immediately.. Thaw rapidly the contents of the ampoules by agitation in water at 25-30°C. Proceed

immediately to next step.. As soon as they are thawed, open ampoules holding them at arm’s length in order to prevent

any risk of injury should an ampoule break.. Once the ampoule is opened, draw up the contents into a 5 ml sterile syringe.. Transfer the suspension into the diluent.. Draw up 2 ml of the contents of the diluent into the syringe.. Rinse the ampoule with these 2 ml and then transfer the rinsing liquid into the diluent. Repeat

the rinsing operation once or twice.. The diluted vaccine prepared as described is mixed by gentle agitation so as to be ready for

use. It should be used immediately after the preparation (all of the diluted vaccine should beused up within one hour). This is why the vaccine suspension should only be prepared as andwhen required.

Gallivac HVT IBD 21

22 UNDESIRABLE EFFECTS

None known.

23 WITHDRAWAL PERIOD

Zero days.

24 SPECIAL STORAGE PRECAUTIONS

Keep out of the reach and sight of children.Store at a temperature lower than 30°C. Avoid freezing or excessive temperatures.


Use immediately after preparation.Do not use if cloudy.

26 SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCT ORWASTE MATERIALS DERIVED FROM SUCH VETERINARY MEDICINAL PRODUCTS

Any unused container or waste materials should be disposed of in accordance with the localrequirements.

27 DATE ON WHICH THE PACKAGE INSERT WAS LAST REVISED

28 OTHER INFORMATION

This diluent may be used with the following products :

Gallivac HVT IBD (EU/2/02/XXX/XX)AAAAAAAAAAA(xxxxxxxxxxxxxxx)

For any information about this veterinary medicinal product, please contact the local representative ofthe marketing authorisation holder.

België/Belgique/BelgienMERIAL BELGIUM S.A./N.V.Bd Sylvain Dupuislaan 243B-1070 Bruxelles – Brussel - BrüsselTél/Tel: + 32-(0) 2 529 49 00

Luxembourg/LuxemburgMERIAL BELGIUM S.A./N.V.Bd Sylvain Dupuislaan 243B-1070 Bruxelles - BrüsselBelgique - BelgienTél: + 32-2 529 49 00

DanmarkMERIAL NORDEN A/SMileparken 20EDK-2740 SkovlundeTlf: +45-44-54-00-40

NederlandMERIAL B.V.Bovenkerkerweg 6-8,NL-1185 XE AMSTELVEENTel: + 31-20 547 39 33

Deutschland Österreich

Gallivac HVT IBD 22

MERIAL GmbHAm Söldnermoos 6D-85399 HallbergmoosTel: + 49-811 9593 0

Richter Pharma AGFeldgasse 19A-4600 WelsTel.: +43 7242 490 0

E��

AGROSEED A.E.Agricultural trading and manufacturing companyPAPADA 2 & MESOGEIVN, 115 25 AUHNATel : + 30-1.698 19 75

PortugalMERIAL PORTUGUESA – Saùde Animal, Lda.Av. Maria Lamas, Lote 19 – BL.A Piso 2Serra das MinasP-2635–432 Rio de MouroTel: + 351- 21 916 9340

EspañaMERIAL Laboratorios SAC/Tarragona n°161E-08014 BarcelonaTel: + 34-93 292 83 83

Suomi/FinlandVETER ABKlockarvägen 114S-15161 Södertälje –Ruotsi/SverigePuh/Tln: + 46- 8 554 203 60

FranceMERIAL11 avenue Albert EinsteinF-69100 Villeurbanne.Tél: + 33-(0) 4 72 72 30 00

SverigeVETER ABKlockarvägen 114S-15161 SödertäljeTln: + 46-(0) 8 554 203 60

IrelandMERIAL ANIMAL HEALTH LimitedPO Box 327,Sandringham House, Sandringham AvenueHarlow Business ParkHarlow, CM 19 5TG - UKTel: + 44-1279 775858

United KingdomMERIAL ANIMAL HEALTH LimitedPO Box 327,Sandringham House, Sandringham AvenueHarlow Business ParkHARLOW, CM 19 5TG - UKTel: + 44-(0)1279 775858

ItaliaMerial Italia S.p.A.Milanofiori - Strada 6 - Palazzo E 5IT - 20090 Assago (MI)Tel +39 02 577661

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS · gallivac hvt ibd 12 particulars to appear on the...

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