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Zulvac 8 Bovis

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Summary for the public


What is Zulvac 8 Bovis?

Zulvac 8 Bovis is a vaccine. It is a suspension for injection that contains inactivated (killed) bluetongue serotype 8 virus.


What is Zulvac 8 Bovis used for?

Zulvac 8 Bovis is used in cattle to protect them against bluetongue disease. Bluetongue disease is an infection that is transmitted by midges and caused by the bluetongue virus (serotype 8). The vaccine is used to prevent viraemia (the presence of the virus in the blood).

The vaccine is given to animals as an injection in the muscle. Two injections are necessary to vaccinate; the first injection is given from three months of age and the second injection three weeks later.

The vaccine will only be used as part of an approved national disease control programme. This is because control of bluetongue is the responsibility of national veterinary authorities in consultation with the European Commission.


How does Zulvac 8 Bovis work?

Zulvac 8 Bovis is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Zulvac 8 Bovis contains a bluetongue virus that has been inactivated so that it cannot cause the disease. When it is given to cattle, the animals’ immune system recognises the virus as ‘foreign’ and makes antibodies against it. In the future, if the animals are exposed to the bluetongue virus the immune system will be able to produce antibodies more quickly. This will help them to protect against the disease.

Zulvac 8 Bovis contains bluetongue virus of one type (‘serotype 8’). The vaccine also contains ‘adjuvants’ (aluminium hydroxide and saponin) to enhance the immune response.


How has Zulvac 8 Bovis been studied?

The safety of the vaccine was studied in laboratory safety studies carried out with Zulvac 8 Bovis in cattle. Results from a series of laboratory safety trials performed with a vaccine of similar composition containing serotypes 1 and 8 and of studies performed with a vaccine of the same composition but of different serotype, used in sheep were presented in order to extrapolate safety conclusions, as the vaccine is intended for use in an emergency situation.

The efficacy of the vaccine in cattle was studied in a laboratory trial using the vaccine in calves from two and a half months of age. Another laboratory study looked at the duration of the immunity following vaccination with Zulvac 8 Bovis. The vaccine was assessed in the context of an emergency situation which means that further studies with Zulvac 8 Bovis are still ongoing and will be assessed.


What benefit has Zulvac 8 Bovis shown during the studies?

The studies showed that the vaccine is safe for cattle and that it prevents viraemia in animals from three months of age that are infected with bluetongue virus serotype 8.

The safety of the vaccine in pregnant cows is not yet fully established. Supportive evidence for the safe use of the vaccine in pregnant cows was provided by the results obtained in studies performed in pregnant sheep with a vaccine of similar composition containing serotype 4.


What is the risk associated with Zulvac 8 Bovis?

After the second injection, animals may show a slight, temporary increase in body temperature of 0.4ºC, in the 24 hours after vaccination.


What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?

The withdrawal period is zero days.


What is the time to allow before milk can be taken from the animal for human consumption?

Milk can be taken after zero days.


Why has Zulvac 8 Bovis been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Zulvac 8 Bovis exceed the risks for active immunisation of cattle to prevent viraemia caused by the bluetongue virus serotype 8, and recommended that Zulvac 8 Bovis should be given a Marketing Authorisation. The benefit-risk balance may be found in module 6 of this EPAR.

Zulvac 8 Bovis has been authorised under ‘Exceptional Circumstances’. This means that it has not been possible to obtain complete information about Zulvac 8 Bovis. Every year, the European Medicines Agency will review additional information that will become available according to an agreed timetable and this summary will be updated as necessary.


What information is still awaited for Zulvac 8 Bovis?

The company that makes Zulvac 8 Bovis will submit an action plan together with timelines for all of the issues that need to be resolved before the authorisation can revert to normal status. It will also supply regular updates on the use and the safety of the vaccine.


Other information about Zulvac 8 Bovis:

The European Commission granted a marketing authorisation valid throughout the EU for Zulvac 8 Bovis to Fort Dodge Animal Health Ltd on 15 January 2010. Information on the prescription status of this product may be found on the label/outer package.

Authorisation details
Name: Zulvac 8 Bovis
EMEA Product number: EMEA/V/C/000145
Active substance: Inactivated bluetongue virus, serotype 8, strain btv-8/bel2006/02
INN or common name: Inactivated blue tongue virus, serotype 8
Species: Cattle
ATCvet Code: QI02AA08
Exceptional Circumstances: There were "exceptional circumstances" concerning the approval of this medicine. This happens when the applicant can show that they are unable to provide comprehensive data on the efficacy and safety of the medicine for which authorisation is being sought, due to the rarity of the condition it is intended for, limited scientific knowledge in the area concerned, or ethical considerations involved in the collection of such data.
Marketing Authorisation Holder: Pfizer Limited
Revision: 2
Date of issue of Market Authorisation valid throughout the European Union: 15/01/2010
Contact address:
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom



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    • Product Characteristics

    ANNEX I

    SUMMARY OF PRODUCT CHARACTERISTICS


    1. NAME OF VETERINARY THE MEDICINAL PRODUCT
    ZULVAC 8 Bovis suspension for injection for cattle
    2. QUALITATIVE AND QUANTITATIVE COMPOSITION
    Each dose of 2 ml of the vaccine contains :
    Active substance:
    Inactivated Bluetongue Virus, serotype 8, strain BTV-8/BEL2006/02
    RP* ≥ 1
    *Relative Potency by a mice potency test compared to a reference vaccine that was shown efficacious
    in cattle.
    Adjuvant:
    Aluminium hydroxide
    4 mg (Al 3+ )
    Saponin
    0.4 mg
    Excipient:
    Thiomersal
    0.2 mg
    For a full list of excipients, see section 6.1.
    3. PHARMACEUTICAL FORM
    Suspension for injection
    4. CLINICAL PARTICULARS
    4.1 Targetspecies
    Cattle
    4.2 Indications for use, specifying the target species
    Active immunisation of cattle from 3 months of age for the prevention* of viraemia caused by
    Bluetongue Virus, serotype 8.
    *(Cycling value (Ct) ≥ 36 by a validated RT- PCR method, indicating no presence of viral genome).
    Onset of immunity: 25 days after administration of the second dose.
    The duration of immunity is at least 12 months after the primary vaccination course.
    4.3 Contraindications
    None.
    4.4 Special warnings
    If used in other domestic and wild ruminant species that are considered at risk of infection, its use in
    these species should be undertaken with care and it is advisable to test the vaccine on a small number
    of animals prior to mass vaccination. The level of efficacy for other species may differ from that
    observed in cattle.
    2/18
    No information is available on the use of the vaccine in seropositive animals including those with
    maternally derived antibodies.
    4.5 Special precautions for use
    Special precautions for use in animals
    Only use in healthy animals.
    Special precautions to be taken by the person administering the veterinary medicinal product to
    animals
    None
    4.6 Adverse reactions (frequency and seriousness)
    No adverse reactions were observed after the first injection of a single dose of vaccine to calves.
    After the second injection of a single dose, a slight and transient but significant increase in the mean
    rectal temperature of 0.4ºC was recorded in the vaccinated calves during the first 24 hours. On day 2
    after vaccination, rectal temperatures had returned to normal values.
    4.7 Use during pregnancy, lactation or lay
    The vaccine can be used during pregnancy.
    The safety and the efficacy of the vaccine have not been established in breeding males. In this
    category of animals the vaccine should be used only according to the benefit/risk assessment by the
    responsible veterinarian and/or national Competent Authorities on the current vaccination policies
    against BTV.
    4.8 Interaction with other medicinal products and other forms of interaction
    No information is available on the safety and efficacy of this vaccine when used with any other
    veterinary medicinal product. A decision to use this vaccine before or after any other veterinary
    medicinal product therefore needs to be made on a case by case basis.
    4.9 Amounts to be administered and administration route
    Intramuscular use:
    Apply usual aseptic procedures.
    Shake gently immediately before use. Avoid bubble formation, as this can be irritating at the site of
    injection. The entire content of the bottle should be used immediately after broaching and during the
    same procedure. Avoid multiple vial broaching.
    In order to avoid accidental contamination of the vaccine during use, it is recommended to use a multi-
    injection type vaccination system when larger dose presentations are used.
    Primary vaccination:
    Administer one dose of 2 ml according to the following vaccination scheme:
    1 st injection: from 3 months of age.
    2 nd injection: after 3 weeks
    Revaccination:
    Any revaccination scheme should be agreed by the Competent Authority or by the responsible
    veterinarian, taking into account the local epidemiological situation.
    4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
    After administration of a double dose, a slight and transient but significant increase in the mean rectal
    temperature of 0.7ºC was recorded in the vaccinated calves during the first 24 hours. On day 2 after
    3/18
    vaccination, rectal temperatures had returned to normal values.
    4.11 Withdrawal period
    Zero days.
    5. IMMUNOLOGICAL PROPERTIES
    Pharmacotherapeutic group: Inactivated viral vaccines – Bluetongue virus vaccine.
    ATC vet code: QI02AA08
    To stimulate active immunity against Bluetongue Virus, serotype 8 in cattle.
    6. PHARMACEUTICAL PARTICULARS
    6.1 List of excipients
    Aluminium hydroxide
    Saponin
    Thiomersal
    Potassium chloride
    Potassium dihydrogen phosphate
    Disodium hydrogen phosphate dodecahydrate
    Sodium chloride
    Water for injections
    6.2 Incompatibilities
    Do not mix with any other veterinary medicinal product.
    6.3 Shelflife
    Shelf-life of the veterinary medicinal product as packaged for sale: 1 year.
    Shelf-life after first opening the immediate packaging: use immediately.
    6.4. Special precautions for storage
    Store and transport refrigerated (2°C - 8°C).
    Protect from light.
    Do not freeze
    6.5 Nature and composition of immediate packaging
    Type I glass bottle (10 doses) or type II glass bottle (50 doses) with butyl elastomere closure
    Pack sizes
    Pack of 1 bottle of 10 doses (20 ml).
    Pack of 1 bottle of 50 doses (100 ml).
    Not all pack sizes may be marketed.
    6.6 Special precautions for the disposal of unused veterinary medicinal product or waste
    materials derived from the use of such products
    Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
    products should be disposed of in accordance with local requirements.
    4/18
    7. MARKETING AUTHORISATION HOLDER
    Pfizer Limited
    Ramsgate Road
    Sandwich, Kent
    CT13 9NJ
    United Kingdom
    8. MARKETING AUTHORISATION NUMBER(S)
    EU/2/09/105/001
    EU/2/09/105/002
    9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
    15/01/2010
    10. DATE OF REVISION OF THE TEXT
    14/03/2011
    Detailed information on this veterinary medicinal product is available on the website of the European
    Medicines Agency (EMA) http://www.ema.europa.eu .
    PROHIBITION OF SALE, SUPPLY AND/OR USE
    The import, sale, supply and/or use of Zulvac 8 Bovis is or may be prohibited in certain Member
    States on the whole or part of their territory pursuant to national animal health policy. Any person
    intending to import, sell, supply and/or use Zulvac 8 Bovis must consult the relevant Member State’s
    competent authority on the current vaccination policies prior to the import, sale, supply and/or use.
    5/18
    ANNEX II
    A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND
    MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR
    BATCH RELEASE
    B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
    REGARDING SUPPLY OR USE
    C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
    WITH REGARD TO SAFE AND EFFECTIVE USE
    D. STATEMENT OF THE MRLs
    E. SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING
    AUTHORISATION HOLDER
    6/18
    A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND
    MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
    RELEASE
    Name and address of the manufacturer of the biological active substance(s)
    Fort Dodge Veterinaria S.A. (Spain)
    Ctra. Camprodón s/n "la Riba"
    17813 Vall de Bianya
    Girona
    Spain
    Fort Dodge Animal Health Holland
    C J van Houtenlaan, 36
    1381 CP Weesp
    The Netherlands
    Name and address of the manufacturer responsible for batch release
    Fort Dodge Veterinaria S.A. (Spain)
    Ctra. Camprodón s/n "la Riba"
    17813 Vall de Bianya
    Girona
    Spain
    B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
    REGARDING SUPPLY OR USE
    Veterinary medicinal product subject to prescription.
    According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as
    amended, Member States prohibit or may prohibit the import, sale, supply and/or use of the veterinary
    medicinal product 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 the
    implementation of national programmes for the diagnosis, control and eradication of animal
    diseases, or will cause difficulties in certifying the absence of contamination in live animals or in
    foodstuffs or other products obtained from treated animals.
    b) the disease to which the veterinary medicinal product is intended to confer immunity is largely
    absent from the territory.
    The use of this veterinary medicinal product is only allowed under the particular conditions
    established by European Community legislation on the control of Bluetongue.
    The holder of this marketing authorisation must inform the European Commission about the marketing
    plans for the medicinal product authorised by this decision.
    7/18
    C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
    WITH REGARD TO SAFE AND EFFECTIVE USE
    Not applicable
    D. STATEMENT OF THE MRLs
    The active substance being a principle of biological origin intended to produce active immunity is not
    within the scope of Regulation (EC) No 470/2009.
    The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances
    for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs
    are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when
    used as in this veterinary medicinal product.
    E. SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING
    AUTHORISATION HOLDER
    1. The Applicant is required to submit in 6 months following the authorisation of the product, an
    action plan together with timelines for all points that require resolution in order for the
    authorisation to revert to normal status. The above information will be evaluated and approved
    by the CVMP and will form part of the subsequent annual reassessment.
    2. For the first and subsequent annual reassessments the Marketing Authorisation Holder should
    provide annually an updated risk assessment on the continuous use of the vaccine taking into
    account the continued need for the vaccine, its history of use over the previous twelve months and
    progress made in addressing the items that require resolution in order for the authorisation to
    revert to normal status.
    3. The Applicant is required to submit 6-monthly Periodic Update Safety reports starting once the
    MA has been approved and, in addition to the legal requirements applicable to reporting of
    suspected adverse reactions, the Applicant is required to specifically monitor and evaluate the
    following suspected adverse reactions in the PSURs: abortions, spontaneous death, effects on
    milk production, local reactions, pyrexia, lethargy and hypersensitivity reactions, including
    severe allergic reactions. The frequency of submissions of PSUR reports will be assessed at the
    annual reassessment of the product.
    8/18
    ANNEX III
    LABELLING AND PACKAGE LEAFLET
    9/18
    A. LABELLING
    10/18
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
    Preprinted carton box 1 x 20ml / Preprinted carton box 1 x 100 ml
    Vial label 100 ml
    1. NAME OF VETERINARY THE MEDICINAL PRODUCT
    ZULVAC 8 Bovis suspension for injection for cattle
    2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Per dose of 2 ml:
    Inactivated Bluetongue Virus, serotype 8, strain BTV-8/BEL2006/02
    Aluminium hydroxide, saponin and thiomersal.
    3. PHARMACEUTICAL FORM
    Suspension for injection.
    4. PACKAGE SIZE
    20ml (10 doses)
    100 ml (50 doses)
    5. TARGET SPECIES
    Cattle
    6. INDICATION(S)
    Active immunisation of cattle from 3 months of age for the prevention of viraemia against Bluetongue
    Virus, serotype 8.
    Read the package leaflet before use.
    7. METHOD AND ROUTE(S) OF ADMINISTRATION
    For intramuscular use.
    Read the package leaflet before use.
    8. WITHDRAWAL PERIOD
    Withdrawal period: Zero days.
    11/18
     
    9. SPECIAL WARNING(S), IF NECESSARY
    Read the package leaflet before use.
    10. EXPIRYDATE
    EXP {month/year}
    Once broached use immediately.
    11. SPECIAL STORAGE CONDITIONS
    Store and transport refrigerated (2°C - 8°C).
    Protect from light.
    Do not freeze.
    12. SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
    WASTE MATERIALS, IF ANY
    Dispose of waste material in accordance with local requirements.
    13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
    RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
    For animal treatment only - to be supplied only on veterinary prescription.
    14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
    Keep out of the reach and sight of children.
    15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
    Pfizer Limited
    Ramsgate Road
    Sandwich, Kent
    CT13 9NJ
    United Kingdom
    16. MARKETINGAUTHORISATIONNUMBER(S)
    EU/2/09/105/001
    EU/2/09/105/002
    17. MANUFACTURER’S BATCH NUMBER
    Lot {number}
    12/18
     
    MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
    Vial label 20 ml
    1. NAME OF VETERINARY THE MEDICINAL PRODUCT
    ZULVAC 8 Bovis suspension for injection for cattle
    2. QUANTITY OF THE ACTIVE SUBSTANCE(S)
    Per dose of 2 ml: Inactivated Bluetongue Virus, serotype 8, strain BTV-8/BEL2006/02
    3. CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
    20ml (10 doses)
    4. ROUTE(S) OF ADMINISTRATION
    Intramuscular use
    5. WITHDRAWAL PERIOD
    Withdrawal period: zero days
    6. BATCH NUMBER
    Lot {number}
    7. EXPIRY DATE
    EXP {month/year}
    Once broached use immediately.
    8. THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only.
    13/18
     
    B. PACKAGE LEAFLET
    14/18
    PACKAGE LEAFLET FOR:
    ZULVAC 8 Bovis
    Suspension for injection for cattle
    1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
    THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
    RELEASE, IF DIFFERENT
    Marketing authorisation holder
    Pfizer Limited
    Ramsgate Road
    Sandwich, Kent
    CT13 9NJ
    United Kingdom
    Manufacturer for the batch release :
    Fort Dodge Veterinaria S.A.
    Ctra. Camprodón s/n “La Riba”
    17813 Vall de Bianya (Gerona)
    Spain
    2. NAME OF VETERINARY THE MEDICINAL PRODUCT
    ZULVAC 8 Bovis suspension for injection for cattle
    3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
    *Relative Potency by a mice potency test compared to a reference vaccine that was shown efficacious
    in cattle.
    RP* ≥ 1
    Adjuvant:
    Aluminium hydroxide
    4 mg (Al 3+ )
    Saponin
    0.4 mg
    Excipient:
    Thiomersal
    0.2 mg
    4. INDICATION(S)
    Active immunisation of cattle from 3 months of age for the prevention* of viraemia caused by
    Bluetongue Virus, serotype 8.
    *(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome)
    Onset of immunity: 25 days after administration of the second dose.
    The duration of immunity is at least 12 months after the primary vaccination course.
    15/18
    Each dose of 2 ml of vaccine contains:
    Inactivated Blue t ongue Virus, serotype 8, strain BTV-8/BEL2006/02
    5. CONTRAINDICATIONS
    None.
    6. ADVERSE REACTIONS
    No adverse reactions were observed after the first injection of a single dose of vaccine to calves.
    After the second injection of a single dose, a slight and transient but significant increase in the mean
    rectal temperature of 0.4ºC was recorded in the vaccinated calves during the first 24 hours. On day 2
    after vaccination, rectal temperatures had returned to normal values.
    After administration of a double dose, a slight and transient but significant increase in the mean rectal
    temperature of 0.7ºC was recorded in the vaccinated calves during the first 24 hours. On day 2 after
    vaccination, rectal temperatures had returned to normal values.
    If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
    veterinary surgeon.
    7. TARGET SPECIES
    Cattle
    8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
    Intramuscular use
    Apply usual aseptic procedures.
    Shake gently immediately before use. Avoid bubble formation, as this can be irritating at the site of
    injection. The entire content of the bottle should be used immediately after broaching and during the
    same procedure. Avoid multiple vial broaching.
    Primary vaccination:
    Administer one dose of 2 ml according to the following vaccination scheme:
    1 st injection: from 3 months of age.
    2 nd injection: after 3 weeks
    Revaccination:
    Any revaccination scheme should be agreed by the Competent Authority or by the responsible
    veterinarian, taking into account the local epidemiological situation.
    9. ADVICE ON CORRECT ADMINISTRATION
    In order to avoid accidental contamination of the vaccine during use, it is recommended to use a multi-
    injection type vaccination system when larger dose presentations are used.
    10. WITHDRAWALPERIOD
    Withdrawal period: Zero days
    11. SPECIAL STORAGE PRECAUTIONS
    Keep out of the reach and sight of children.
    Store and transport refrigerated (2°C - 8°C).
    16/18
    Protect from light.
    Do not freeze
    Once broached use immediately.
    12. SPECIALWARNING(S)
    Only use in healthy animals.
    No information is available on the safety and efficacy of this vaccine when used with any other
    veterinary medicinal product. A decision to use this vaccine before or after any other veterinary
    medicinal product therefore needs to be made on a case by case basis.
    No information is available on the use of the vaccine in seropositive animals including those with
    maternally derived antibodies.
    If used in other domestic and wild ruminant species that are considered at risk of infection, its use in
    these species should be undertaken with care and it is advisable to test the vaccine on a small number
    of animals prior to mass vaccination. The level of efficacy for other species may differ from that
    observed in cattle.
    Can be used during pregnancy.
    The safety and the efficacy of the vaccine have not been established in breeding males. In this
    category of animals the vaccine should be used only according to the benefit/risk assessment by the
    responsible veterinarian and/or national Competent Authorities on the current vaccination policies
    against BTV.
    Do not mix with any other veterinary medicinal product.
    13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
    MATERIALS, IF ANY
    Medicines should not be disposed of via wastewater or household waste. Ask your veterinary surgeon
    how to dispose of medicines no longer required. These measures should help protect the environment.
    14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
    14/03/2011
    Detailed information on this product is available on the website of the European Medicines Agency
    15. OTHERINFORMATION
    Pack sizes
    Pack of 1 bottle of 10 doses (20 ml).
    Pack of 1 bottle of 50 doses (100 ml).
    Not all pack sizes may be marketed.
    The import, sale, supply and/or use of Zulvac 8 Bovis is or may be prohibited in certain Member
    States on the whole or part of their territory pursuant to national animal health policy. Any person
    intending to import, sell, supply and/or use Zulvac 8 Bovis must consult the relevant Member State’s
    competent authority on the current vaccination policies prior to the import, sale, supply and/or use.
    België/Belgique/Belgien
    Pfizer Animal Health s.a.,
    Tél.: +32 (0)2 554 62 11
    Luxembourg
    Pfizer Animal Health s.a.,
    Tél.: + 32 (0)2 554 62 11
    17/18
    Република България
    Pfizer Luxembourg SARL
    Tel: + 359 2 970 43 21
    Magyarország
    Pfizer Kft.
    Tel: +361 488 3695
    Česká Republika
    Pfizer Animal Health
    Tel: +420 283 004 111
    Malta
    Agrimed Limited
    Tel: +356 21 465 797
    Danmark
    Pfizer Oy Animal Health,
    Tlf: +358 (0)9 4300 40
    Nederland
    Pfizer Animal Health B.V.,
    Tel: +31 (0)10 4064 600
    Deutschland
    Pfizer GmbH
    Tel: +49 30-5500 5501
    Norge
    Pfizer Oy Animal Health,
    Tlf: +358 (0)9 4300 40
    Eesti
    Pfizer Animal Health
    Tel: +370 5 269 17 96
    Österreich
    Pfizer Corporation Austria Ges.m.b.H.
    Tel: +43 (0)1 52 11 57 20
    Ελλάδα
    Pfizer Hellas A.E.
    Τηλ.: +30 210 6785800
    Polska
    Pfizer Trading Polska Sp. z.o.o.
    Tel: +48 22 335 61 00
    España
    PfizerS.L..
    Tel: +34 91 4909900
    Portugal
    Laboratórios Pfizer, Lda.
    Tel: +351 21 423 55 00
    France
    Pfizer
    Tél: +33 (0)1 58 07 46 00
    Romania
    Pfizer Romania SRL
    Tel: + 0040 21 207 28 93
    Ireland
    Pfizer Healthcare Ireland, Trading As:
    Pfizer Animal Health
    Tel: +353 (0) 1 467 6500
    Slovenija
    Pfizer Luxembourg SARL
    Tel: +386 (0) 1 52 11 670
    Ìsland
    Pfizer Oy Animal Health,
    Tel: +358 (0)9 4300 40
    Slovenská Republika
    Pfizer Luxembourg SARL o.z.
    Tel: + 421 2 3355 5500
    Italia
    Pfizer Italia S.r.l.,
    Tel: +39 06 3318 2933
    Suomi/Finland
    Pfizer Oy Animal Health,
    Puh/Tel: +358 (0)9 4300 40
    Kύπρος
    Pfizer Hellas A.E.
    Τηλ.: +30 210 6785800
    Sverige
    Pfizer Oy Animal Health,
    Tel: +358 (0)9 4300 40
    Latvija
    Pfizer Animal Health
    Tel: +370 5 269 17 96
    United Kingdom
    Pfizer Ltd
    Tel: +44 (0) 1304 616161
    Lietuva
    Pfizer Animal Health
    Tel: +370 5 269 17 96
    18/18


    Source: European Medicines Agency


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