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Cortavance

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Summary for the public


What is Cortavance?

Cortavance is a spray containing a solution of the active substance hydrocortisone aceponate.


What is Cortavance used for?

Cortavance is used to treat inflamed and itchy skin conditions in dogs. Cortavance is given once a day for 7 days. It is sprayed on the affected area, avoiding the eyes. The pump delivers in two sprays enough medicine to treat an area of about 100 cm2. If no improvement is seen after 7 days, the treatment should be re-evaluated by a veterinarian.


How does Cortavance work?

The active substance in Cortavance, hydrocortisone aceponate, is a steroid which is a type of substance that helps to reduce inflammation. The steroid is in a special chemical form (a diester) that makes it effective at low doses in skin conditions as the medicine is able to get into and remain longer in the outer layer of the skin.


How has Cortavance been studied?

The clinical part of the dossier consisted of studies to determine the dose and of one field trial. The field trial consisted of a multi-site study comparing treatment of dogs with itchy skin conditions with Cortavance to treatment with a different steroid-containing product. Fifty-four dogs were treated with Cortavance and 51 with this other product.


What benefit has Cortavance shown during the studies?

The studies to determine the dose generally supported the chosen dose and the length of treatment. Significant improvement of the skin condition was demonstrated in several studies under controlled conditions, whereas significant reduction of itching was demonstrated in only one of these laboratory studies in which the dogs received treatment against external parasites at the same time. Results from the field trial indicated comparable efficacy between Cortavance and the comparator product.


What is the risk associated with Cortavance?

There are no side effects reported in animals who have been treated with Cortavance. The treatment area should not normally exceed an area corresponding to the two flanks of the animal. Before treatment, any other existing skin conditions (such as an infection) must be treated and Cortavance should not be used on skin ulcers. The medicine should not normally be used in dogs suffering from Cushing’s syndrome (a disorder where the body produces too much natural steroid), and in young animals (under 7 months of age) as steroids are known to slow growth.


What are the precautions for the person who gives the medicine or comes into contact with the animal?

Wash hands after use. In case of accidental contact (skin, eye), wash thoroughly with water.

In case of accidental ingestion, seek medical advice immediately and show the leaflet or the label to the physician.

Spray preferably in a well ventilated area. The spray is flammable and should not be used next to a naked flame or any incandescent material. Do not smoke when applying this product.


Why has Cortavance been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Cortavance exceed the risks for the treatment of inflamed and itchy skin conditions and recommended that Cortavance be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.


Other information about Cortavance

The European Commission granted a marketing authorisation valid throughout the European Union, for Cortavance to Virback S.A. on 09/01/2007. Information on the prescription status of this product may be found on the label/outer package.

Authorisation details
Name: Cortavance
EMEA Product number: EMEA/V/C/000110
Active substance: hydrocortisone aceponate
INN or common name: hydrocortisone
Species: Dogs
ATCvet Code: QD07AC
Marketing Authorisation Holder: Virbac S.A.
Revision: 2
Date of issue of Market Authorisation valid throughout the European Union: 09/01/2007
Contact address:
Virbac S.A.
1ère Avenue 2065 M
06516 Carros
France



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    • Product Characteristics

    ANNEX I

    SUMMARY OF PRODUCT CHARACTERISTICS


    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    CORTAVANCE 0.584 mg/ml cutaneous spray solution for dogs
    2.
    QUALITATIVE AND QUANTITATIVE COMPOSITION
    Active substance:
    Hydrocortisone aceponate
    0.584 mg/ml.
    For a full list of excipients see section 6.1.
    3.
    PHARMACEUTICAL FORM
    Cutaneous spray, solution.
    4.
    CLINICAL PARTICULARS
    4.1 Target species
    Dogs
    4.2 Indications for use, specifying the target species
    For symptomatic treatment of inflammatory and pruritic dermatoses in dogs.
    4.3 Contraindications
    Do not use on cutaneous ulcers.
    4.4 Special warnings for each target species
    Total body surface treated should not exceed a surface corresponding for example to a treatment of
    two flanks from the spine to the mammary chains including the shoulders and the thighs. Otherwise,
    use only according to the risk-benefit assessment and subject the dog to regular clinical evaluations.
    4.5 Special precautions for use
    Special precautions for use in animals
    In the case of concurrent microbial disease or parasitic infestation, the dog should receive appropriate
    treatment for such condition.
    In the absence of specific information, the use in animal suffering from Cushing’s syndrome shall be
    based on the risk-benefit assessment.
    Since glucocorticosteroids are known to slow growth, use in young animals (under 7 months of age)
    shall be based on the risk-benefit assessment and subject to regular clinical evaluations.
    In 12 dogs suffering from atopic dermatitis, after topical application on the skin at the recommended
    therapeutic dosage for 28 to 70 consecutive days, no noticeable effect on the systemic cortisol level
    was observed.
    2
    Special precautions to be taken by the person administering the veterinary medicinal product to
    animals
    In case of accidental skin contact, it is recommended to wash thoroughly with water. Wash hands after
    use.
    Avoid contact with eyes. In case of accidental eye contact, rinse with abundant quantities of water. In
    case of eye irritation, seek medical advice.
    In case of accidental ingestion, seek medical advice immediately and show the leaflet or the label to
    the physician.
    Spray preferably in a well ventilated area.
    Flammable.
    Do not spray on naked flame or any incandescent material. Do not smoke while handling the
    veterinary medicinal product.
    The solvent in this product may stain certain materials including painted, varnished or other household
    surfaces or furnishings. Allow the application site to dry before permitting contact with such materials.
    4.6 Adverse reactions (frequency and seriousness)
    None.
    4.7 Use during pregnancy, lactation or lay
    The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
    Systemic absorption of hydrocortisone aceponate being negligible, it is unlikely for teratogenic,
    foetotoxic, maternotoxic effects to happen at the recommended dosage in dogs.
    Use only accordingly to the risk-benefit assessment by the responsible veterinarian.
    4.8 Interaction with other medicinal products and other forms of interaction
    In the absence of information, it is recommended not to apply other topical preparations
    simultaneously on the same lesions.
    4.9 Amounts to be administered and administration route
    Cutaneous use.
    Before administration, screw the pump spray on the bottle.
    The veterinary medicinal product is then applied by activating the pump spray, from a distance of
    about 10 cm of the area to be treated.
    The recommended dosage is 1.52 µg of hydrocortisone aceponate/cm 2 of affected skin per day. This
    dosage can be achieved with two pump spray activations over a surface to be treated equivalent to a
    square of 10 cm x 10 cm. Repeat the treatment daily for 7 consecutive days.
    Care should be taken to avoid spraying into the eyes of the animal.
    Presented as a volatile spray, this veterinary medicinal product does not require any massage.
    In case of conditions requiring an extended treatment, the responsible veterinarian should subject the
    use of the veterinary medicinal product to the risk-benefit assessment.
    If signs fail to improve within 7 days, treatment should be re-evaluated by the veterinarian.
    3
    4.10 Overdose (symptoms, emergency procedures, antidotes)
    After topical application on the skin at the recommended therapeutic dosage and twice the
    recommended duration of treatment and at up to a body surface corresponding to the two flanks, from
    the spine to the mammary chains including the shoulder and the thighs, no systemic effects are
    observed.
    Tolerance studies using 3 and 5 times the recommended dosage for twice the recommended duration
    of treatment resulted in a reduced capacity for production of cortisol that is fully reversible within 7 to
    9 weeks after the end of treatment.
    4.11 Withdrawalperiods
    Not applicable.
    5.
    PHARMACOLOGICAL PROPERTIES
    Pharmacotherapeutic group: Glucorticosteroids, dermatological preparations.
    ATCvet code: QD07AC.
    5.1 Pharmacodynamic properties
    The veterinary medicinal product contains the active substance hydrocortisone aceponate.
    Hydrocortisone aceponate (HCA) is a dermocorticoid with a potent intrinsic glucocorticoid activity
    which means a relief of both inflammation and pruritus leading to a quick improvement of skin lesions
    observed in case of inflammatory and pruritic dermatosis.
    5.2 Pharmacokinetic particulars
    HCA belongs to the diesters class of the glucocorticosteroids.
    The diesters are lipophilic components ensuring an enhanced penetration into the skin associated to a
    low plasma availability. HCA thus accumulates in the dog’s skin allowing local efficacy at low
    dosage. The diesters are transformed inside the skin structures. This transformation is responsible for
    the potency of the therapeutic class. In laboratory animals, hydrocortisone aceponate is eliminated the
    same way as hydrocortisone (other name for endogenous cortisol) through urine and faeces.
    Topical application of diesters results in high therapeutic index: high local activity with reduced
    systemic secondary effects.
    6.
    PHARMACEUTICAL PARTICULARS
    6.1 List of excipients
    Propylene glycol methyl ether.
    6.2 Incompatibilities
    None known.
    6.3 Shelf life
    Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.
    Shelf-life after first opening the immediate packaging: 6 months.
    4
    6.4. Special precautions for storage
    This veterinary medicinal product does not require any special storage conditions.
    6.5 Nature and composition of immediate packaging
    Box containing a polyethylene terephtalate (PET) bottle filled with 76 ml of solution, closed with an
    aluminium screw cap or a white plastic screw cap and a pump spray.
    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.
    7.
    MARKETING AUTHORISATION HOLDER
    VIRBAC S.A.
    1 ère avenue 2065 m L.I.D.
    06516 Carros
    FRANCE
    0033/4.92.08.73.00
    0033/4.92.08.73.48
    dar@virbac.fr
    8.
    MARKETING AUTHORISATION NUMBER
    EU/2/06/069/001
    9.
    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
    9 January 2007
    10 DATE OF REVISION OF THE TEXT
    02/07/2010
    PROHIBITION OF SALE, SUPPLY AND/OR USE
    Not applicable.
    5
    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
    6
    A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
    RELEASE
    Name and address of the manufacturer(s) responsible for batch release
    VIRBAC SA
    1 ère Avenue - 2065 m – L.I.D
    06516 Carros, France
    B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
    REGARDING SUPPLY OR USE
    To be supplied only on veterinary prescription.
    C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
    REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
    Not applicable.
    D. STATEMENT OF THE MRLs
    Not applicable.
    7
    ANNEX III
    LABELLING AND PACKAGE LEAFLET
    8
    A. LABELLING
    9
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    Carton box
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    CORTAVANCE 0.584 mg/ml cutaneous spray solution for dogs.
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Hydrocortisone aceponate
    0.584 mg/ml.
    Contains no preservative.
    3.
    PHARMACEUTICAL FORM
    Cutaneous spray, solution.
    4.
    PACKAGE SIZE
    Bottle containing 76 ml of solution.
    5.
    TARGET SPECIES
    Dogs
    6.
    INDICATION(S)
    For symptomatic treatment of inflammatory and pruritic dermatoses in dogs.
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    Cutaneous use.
    Read the package leaflet before use.
    8.
    WITHDRAWAL PERIOD
    Not applicable.
    10
     
    9.
    SPECIAL WARNING(S), IF NECESSARY
    Total body surface treated should not exceed a surface corresponding for example to a treatment of
    two flanks from the spine to the mammary chains including the shoulders and the thighs. Otherwise,
    use only according to the risk-benefit assessment by the responsible veterinarian and subject the dog to
    regular clinical evaluations.
    10. EXPIRY DATE
    EXP {MM/AA/AA}
    Once opened, use by 6 months.
    11. SPECIAL STORAGE CONDITIONS
    This veterinary medicinal product does not require any special storage conditions.
    12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
    WASTE MATERIALS, IF ANY
    Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
    products should be disposed of 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
    VIRBAC S.A.
    1 ère avenue 2065 m L.I.D.
    06516 Carros
    FRANCE
    16. MARKETING AUTHORISATION NUMBER(S)
    EU/2/06/069/001
    17. MANUFACTURER’S BATCH NUMBER
    Batch {number}
    11
     
    PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
    Bottle
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    CORTAVANCE 0.584 mg/ml cutaneous spray solution for dogs
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Hydrocortisone aceponate
    0.584 mg/ml.
    Contains no preservative.
    3.
    PHARMACEUTICAL FORM
    Cutaneous spray, solution.
    4.
    PACKAGE SIZE
    Bottle containing 76 ml of solution.
    5.
    TARGET SPECIES
    Dogs
    6.
    INDICATION(S)
    For symptomatic treatment of inflammatory and pruritic dermatoses in dogs.
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    Cutaneous use.
    Read the package leaflet before use.
    8.
    WITHDRAWAL PERIOD
    Not applicable.
    12
     
    9.
    SPECIAL WARNING(S), IF NECESSARY
    Total body surface treated should not exceed a surface corresponding for example to a treatment of
    two flanks from the spine to the mammary chains including the shoulders and the thighs. Otherwise,
    use only according to the risk-benefit assessment by the responsible veterinarian and subject the dog to
    regular clinical evaluations.
    10. EXPIRY DATE
    EXP {MM/AA/AA}
    Once opened, use by 6 months.
    11. SPECIAL STORAGE CONDITIONS
    This veterinary medicinal product does not require any special storage conditions.
    12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
    WASTE MATERIALS, IF ANY
    Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
    products should be disposed of 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
    VIRBAC S.A.
    1 ère avenue 2065 m L.I.D.
    06516 Carros
    FRANCE
    16. MARKETING AUTHORISATION NUMBER(S)
    EU/2/06/069/001
    17. MANUFACTURER’S BATCH NUMBER
    Batch {number}
    13
     
    B. PACKAGE LEAFLET
    14
    PACKAGE LEAFLET
    CORTAVANCE 0.584 mg/ml cutaneous spray solution for dogs
    1.
    NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
    THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
    RELEASE, IF DIFFERENT
    Marketing authorisation holder and manufacturer:
    VIRBAC S.A.
    1 ère avenue 2065 m L.I.D
    06516 Carros
    FRANCE
    2.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    CORTAVANCE 0.584 mg/ml cutaneous spray solution for dogs
    3.
    STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
    Hydrocortisone aceponate
    0.584 mg/ml.
    Contains no preservative.
    4.
    INDICATIONS
    For symptomatic treatment of inflammatory and pruritic dermatoses in dogs.
    5.
    CONTRAINDICATIONS
    Do not use on cutaneous ulcers.
    6.
    ADVERSE REACTIONS
    None known.
    If you notice any serious effects or other effects not mentioned in this leaflet, please inform you
    veterinary surgeon.
    7.
    TARGET SPECIES
    Dogs
    8.
    DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
    Cutaneous use.
    Before administration, screw the pump spray on the bottle.
    15
    The veterinary medicinal product is then applied by activating the pump spray, from a distance of
    about 10 cm of the area to be treated.
    The recommended dosage is 1.52 µg of hydrocortisone aceponate/cm 2 of affected skin per day. This
    dosage can be achieved with two pump spray activations over a surface to be treated equivalent to a
    square of 10 cm x 10 cm. Repeat the treatment daily for 7 consecutive days.
    Care should be taken to avoid spraying into the eyes of the animal.
    Presented as a volatile spray, this veterinary medicinal product does not require any massage.
    In case of conditions requiring an extended treatment, the responsible veterinarian should subject the
    use of the product to the risk-benefit assessment by the responsible veterinarian.
    If signs fail to improve within 7 days, treatment should be re-evaluated by the veterinarian
    9.
    ADVICE ON CORRECT ADMINISTRATION
    Spray preferably in a well ventilated area.
    Flammable.
    Do not spray on naked flame or any incandescent material. Do not smoke while handling the product.
    10. WITHDRAWAL PERIOD
    Not applicable.
    11. SPECIAL STORAGE PRECAUTIONS
    Keep out of the reach and sight of children.
    This veterinary medicinal product does not require any special storage conditions.
    Do not use after the expiry date stated on the label.
    Shelf-life after first opening the container: 6 months.
    12. SPECIAL WARNING(S)
    Special precautions for use in animals
    In the case of concurrent microbial disease or parasitic infestation, the dog should receive appropriate
    treatment for such condition.
    In the absence of specific information, the use in animal suffering from Cushing’s syndrome shall be
    based on the risk-benefit assessment.
    Since glucocorticosteroids are known to slow growth, use in young animals (under 7 months of age)
    shall be based on the risk-benefit assessment and subject to regular clinical evaluations.
    In 12 dogs suffering from atopic dermatitis, after topical application on the skin at the recommended
    therapeutic dosage for 28 to 70 consecutive days, no noticeable effect on the systemic cortisol level
    was observed.
    Total body surface treated should not exceed a surface corresponding for example to a treatment of
    two flanks from the spine to the mammary chains including the shoulders and the thighs. Otherwise,
    use only according to the risk-benefit assessment and subject the dog to regular clinical evaluations
    16
    The safety of the veterinary medicinal product has not been established during pregnancy and
    lactation. Systemic absorption of hydrocortisone aceponate being negligible, it is unlikely for
    teratogenic, foetotoxic, maternotoxic effects to happen at the recommended dosage in dogs.
    Use only accordingly to the risk-benefit assessment by the responsible veterinarian.
    Special precautions to be taken by the person administering the veterinary medicinal product to
    animals
    In case of accidental skin contact, it is recommended to wash thoroughly with water. Wash hands after
    use.
    Avoid contact with eyes. In case of accidental eye contact, rinse with abundant quantities of water. In
    case of eye irritation, seek medical advice.
    In case of accidental ingestion, seek medical advice immediately and show the leaflet or the label to
    the physician.
    In the absence of information, it is recommended not to apply other topical preparations
    simultaneously on the same lesions.
    The solvent in this product may stain certain materials including painted, varnished or other household
    surfaces or furnishings. Allow the application site to dry before permitting contact with such materials.
    13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
    MATERIALS, IF ANY
    Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
    products should be disposed of in accordance with local requirements.
    14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
    02/07/2010
    15. OTHER INFORMATION
    Hydrocortisone aceponate (HCA) administered topically accumulates and is metabolised in skin, as
    suggested by radioactivity distribution studies and pharmacokinetic data. This results in minimal
    amounts to reach the blood stream. This particularity will increase the ratio between the desired local
    anti-inflammatory effect in the skin and the undesirable systemic effects.
    HCA applications on the skin lesions provide rapid reduction of the skin redness, irritation and
    scratching while minimising the general effects.
    After topical application on the skin at the recommended therapeutic dosage and twice the
    recommended duration of treatment and at up to a body surface corresponding to the two flanks, from
    the spine to the mammary chains including the shoulder and the thighs, no systemic effects are
    observed.
    Tolerance studies using 3 and 5 times the recommended dosage for twice the recommended duration
    of treatment resulted in a reduced capacity for production of cortisol that is fully reversible within 7 to
    9 weeks after the end of treatment.
    Box containing a bottle.
    17
    For any information about this veterinary medicinal product, please contact the local representative of
    the marketing authorisation holder.
    België/Belgique/Belgien
    VIRBAC BELGIUM S.A.
    Rue de la station 17
    B-1300 WAVRE
    Tel: 32 (0) 10 47 06 35
    Luxembourg/Luxemburg
    VIRBAC BELGIUM S.A.
    Rue de la station 17
    B-1300 WAVRE
    Tel: 32 (0) 10 47 06 35
    Česká republika
    VIRBAC S.A.
    1 ère avenue 2065 m – L.I.D
    F-06516 Carros
    Tel: 33 (0) 4 92 08 73 00
    Magyarország
    VIRBAC S.A.
    1 ère avenue 2065 m – L.I.D
    F-06516 Carros
    Tel: 33 (0) 4 92 08 73 00
    Danmark
    VIRBAC Danmark A/S
    Profilvej 1
    6000 Kolding
    Tel: 45 75521244
    Malta
    VIRBAC S.A.
    1 ère avenue 2065 m – L.I.D
    F-06516 Carros
    Tel: 33 (0) 4 92 08 73 00
    Deutschland
    VIRBAC Tierarzneimittel GmbH
    West Rögen 20
    D-23843 Bad Oldesloe
    Tel: 49 (4531) 805 555
    Nederland
    VIRBAC NEDERLAND BV
    Hermesweg 15
    NL-3771 ND-Barneveld
    Tel: 31 (0) 342 427 127
    Eesti
    OÜ ZOOVETVARU
    Uusaru 5
    ET - 76505 Saue/Harjumaa, ESTONIA
    Tel: + 372 6 709 006
    Norge
    VIRBAC S.A.
    1 ère avenue 2065 m – L.I.D
    F-06516 Carros
    Tel: 33 (0) 4 92 08 73 00
    Ελλάδα
    VIRBAC HELLAS A.E.
    23 rd Klm National Road Athens-Lamia
    145 65 Agios Stefanos
    Athens
    GREECE
    Österreich
    VIRBAC Österreich GmbH
    Hildebrandgasse 27
    A-1180 Wien
    Tel: 43 (0) 1 21 834 260
    España
    VIRBAC ESPAŇA S.A.
    C/Angel Guimera
    179-181 – 08950 – Esplugues de Llobregat
    E-Barcelona
    Tel: + 34 93 470 79 40
    Polska
    VIRBAC S.A.
    1 ère avenue 2065 m – L.I.D
    F-06516 Carros
    Tel: 33 (0) 4 92 08 73 00
    France
    VIRBAC S.A.
    1 ère avenue 2065 m – L.I.D
    F-06516 Carros
    Tel: 33 (0) 4 92 08 73 00
    Portugal
    VIRBAC DE Portugal
    LABORATÓRIOS LDA
    P-2080 Almeirim
    Tel: (351) 243 570 500
    Ireland
    C&M Veterinary Distributors Limited
    IE-Limerick
    Tel: 353 61 314 933
    Slovenija
    VIRBAC S.A.
    1 ère avenue 2065 m – L.I.D
    F-06516 Carros
    Tel: 33 (0) 4 92 08 73 00
    18
    Ísland
    VIRBAC S.A.
    1 ère avenue 2065 m – L.I.D
    F-06516 Carros
    Tel: 33 (0) 4 92 08 73 00
    Slovenská republika
    VIRBAC S.A.
    1 ère avenue 2065 m – L.I.D
    F-06516 Carros
    Tel: 33 (0) 4 92 08 73 00
    Italia
    VIRBAC SRL
    Via dei Gracchi 30
    I-20146 Milano
    Tel: 39 02 48 53 541
    Suomi/Finland
    VIRBAC S.A.
    1 ère avenue 2065 m – L.I.D
    F-06516 Carros
    Tel: 33 (0) 4 92 08 73 00
    Κύπρος
    GEO. PAVLIDES & ARAOUZOS LTD
    25-27 Dimostheni Severi, 1080
    CY-1080 Nicosia - CYPRUS
    Τηλ: + 357 22456117
    Sverige
    VIRBAC S.A.
    1 ère avenue 2065 m – L.I.D
    F-06516 Carros
    Tel: 33 (0) 4 92 08 73 00
    Lietuva
    OÜ ZOOVETVARU
    Uusaru 5
    ET - 76505 Saue/Harjumaa, ESTONIA
    Tel: + 372 6 709 006
    Република България
    VIRBAC S.A.
    1 ère avenue 2065 m – L.I.D
    F-06516 Carros
    Tel: 33 (0) 4 92 08 73 00
    România
    VIRBAC S.A.
    1 ère avenue 2065 m – L.I.D
    F-06516 Carros
    Tel: 33 (0) 4 92 08 73 00
    19
    Latvija
    OÜ ZOOVETVARU
    Uusaru 5
    ET - 76505 Saue/Harjumaa, ESTONIA
    Tel: + 372 6 709 006
    United Kingdom
    VIRBAC Ltd
    UK-Suffolk IP30 9 UP
    Tel: 44 (0) 1359 243243


    Source: European Medicines Agency


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