ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

Transcription

1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1

2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT YPOZANE mg tablets for dogs YPOZANE 3.75 mg tablets for dogs YPOZANE 7.5 mg tablets for dogs YPOZANE 15 mg tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Each tablet contains mg, 3.75 mg, 7.5 mg or 15 mg osaterone acetate Excipients: For a full list of excipients, see section PHARMACEUTICAL FORM Tablet Round, white, biconvex tablet of 5.5 mm, 7 mm, 9 mm and 12 mm. 4. CLINICAL PARTICULARS 4.1 Target species Dogs (male) 4.2 Indications for use, specifying the target species Treatment of benign prostatic hypertrophy (BPH) in male dogs. 4.3 Contraindications None. 4.4 Special warnings In dogs with BPH associated with prostatitis, the product can be administered concurrently with antimicrobials. 4.5 Special precautions for use Special precautions for use in animals A transient reduction of plasma cortisol concentration may occur; this may continue for several weeks after administration. Appropriate monitoring should be implemented in dogs under stress (e.g. postoperative) or those with hypoadrenocorticism. The response to an ACTH stimulation test may also be suppressed for several weeks after administration of osaterone. Use with caution in dogs with a history of liver disease, as safety of use of the product in these dogs has not been thoroughly investigated, and as treatment of some dogs with liver disease has resulted in reversible elevation of ALT and ALP in clinical trials. 2

3 Special precautions to be taken by the person administering the veterinary medicinal product to animals Wash hands after administration. In the case of accidental ingestion by a person, seek medical advice immediately and show the package leaflet or the label to the physician. A single oral dose of 40 mg osaterone acetate in human males was followed by a sporadic decrease in FSH, LH and testosterone, reversible after 16 days. There was no clinical effect. In female laboratory animals, osaterone acetate caused serious adverse effects on reproductive functions. Therefore, women of child-bearing age should avoid contact with, or wear disposable gloves, when administering the product. 4.6 Adverse reactions (frequency and seriousness) Transient modifications of appetite can be observed, either increased (very common) or decreased (very rare). Transient behavioural changes such as increased or decreased activity, or more sociable behaviour, are common. Other adverse reactions, including transient vomiting and/or diarrhoea, polyuria/polydipsia or lethargy occur uncommonly. Mammary gland hyperplasia occurs uncommonly and can be associated with lactation in very rare cases. Transient side-effects of changes in the hair coat such as hair loss or hair modification have been seen very rarely following administration of Ypozane. A transient reduction in plasma cortisol occurs in most treated animals. In clinical trials, treatment with the veterinary medicinal product was not discontinued and all dogs recovered without any specific therapy. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports). 4.7 Use during pregnancy, lactation or lay Not applicable. 4.8 Interaction with other medicinal products and other forms of interaction None known. 4.9 Amounts to be administered and administration route For oral use. Administer mg osaterone acetate per kilogram bodyweight, once a day, for 7 days as follows: 3

4 Dog s weight YPOZANE tablets to be administered 3 to 7.5 kg* mg tablet 7.5 to 15 kg 3.75 mg tablet 15 to 30 kg 7.5 mg tablet 30 to 60 kg 15 mg tablet Number of tablets per day Treatment duration 1 tablet 7 days *No data are available for dogs less than 3 kg bodyweight Tablets can be given either directly into the mouth or with food. The maximum dose should not be exceeded. The onset of clinical response to treatment is usually seen within 2 weeks. The clinical response persists for at least 5 months after treatment. Re-evaluation by the veterinarian should take place 5 months after treatment or earlier if clinical signs recur. A decision to retreat at this or at a later time point should be based on veterinary examination taking into account the risk benefit profile of the product. If clinical response to treatment is considerably shorter than expected, a re-evaluation of the diagnosis is necessary Overdose (symptoms, emergency procedures, antidotes), if necessary An overdose study (up to 1.25 mg/kg bodyweight for 10 days, repeated one month later) did not show undesirable effects except for a decrease of cortisol plasma concentration Withdrawal period(s) Not applicable. 5. PHARMACOLOGICAL PROPERTIES Pharmacotherapeutic group: drugs used in benign prostatic hypertrophy. ATC vet code : QG04C X Osaterone is a steroid anti-androgen, which inhibits the effects of an excess production of male hormone (testosterone). 5.1 Pharmacodynamic properties Osaterone acetate is a steroid chemically related to progesterone, and as such it has potent progestagen and potent anti-androgen activity. Also, the major metabolite of osaterone acetate (15β-hydroxylated - osaterone acetate) has anti-androgenic activity. Osaterone acetate inhibits the effects of an excess of male hormone (testosterone) through various mechanisms. It competitively prevents the binding of androgens to their prostatic receptors and blocks the transport of testosterone into the prostate. No adverse effects on semen quality have been observed. 5.2 Pharmacokinetic particulars After oral administration with food in dogs, osaterone acetate is rapidly absorbed (T max about 2 hours) and undergoes a first-pass effect mainly in the liver. After a dose of 0.25 mg/kg/day, the mean maximum concentration (C max) in plasma is about 60 µg/l. 4

5 Osaterone acetate is converted to its main, 15β-hydroxylated metabolite, which is also pharmacologically active. Osaterone acetate and its metabolite are bound to plasma proteins (around 90% and 80% respectively), mainly to albumin. This binding is reversible and not affected by other substances known to specifically bind to albumin. Osaterone is eliminated within 14 days, mainly in faeces via biliary excretion (60%) and to a lesser extent (25%) in urine. Elimination is slow with a mean half-life (T½) of about 80 hours. After repeated administration of osaterone acetate at 0.25 mg/kg/day for 7 days, the factor of accumulation is about 3-4 without change in the rates of absorption or elimination. Fifteen days after the last administration, the mean plasma concentration is about 6.5 µg/l. 6. PHARMACEUTICAL PARTICULARS 6.1 List of excipients Lactose monohydrate Pregelatinised starch Carmellose calcium Maize starch Talc Magnesium stearate 6.2 Major incompatibilities Not applicable. 6.3 Shelf life Shelf-life of the veterinary medicinal product as packaged for sale: 3 years Special precautions for storage This veterinary medicinal product does not require any special storage conditions. 6.5 Nature and composition of immediate packaging Carton box containing one aluminium/aluminium blister with 7 tablets. 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 1 ère avenue 2065 m LID Carros France 8. MARKETING AUTHORISATION NUMBER(S) 5

6 EU/2/06/068/001 EU/2/06/068/002 EU/2/06/068/003 EU/2/06/068/ DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 11/01/2007 Date of latest renewal: 19/12/ DATE OF REVISION OF THE TEXT Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable. 6

7 ANNEX II A. 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 7

8 A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release Virbac S.A. 1 ère avenue 2065 m LID Carros France B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE To be supplied only on veterinary prescription The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision. C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE Not applicable D. STATEMENT OF THE MRLs Not applicable 8

9 ANNEX III LABELLING AND PACKAGE LEAFLET 9

10 A. LABELLING 10

11 PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX mg 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Ypozane mg tablets for dogs Osaterone acetate 2. STATEMENT OF ACTIVE SUBSTANCES Each tablet contains mg osaterone acetate. 3. PHARMACEUTICAL FORM Tablet. 4. PACKAGE SIZE 7 tablets. 5. TARGET SPECIES Dogs. 6. INDICATION(S) Treatment of benign prostatic hypertrophy in male dogs. 7. METHOD AND ROUTE(S) OF ADMINISTRATION Oral use. Read the package leaflet before use. 8. WITHDRAWAL PERIOD(S) Not applicable 9. SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use. 11

12 10. EXPIRY DATE EXP {month/year} 11. SPECIAL STORAGE CONDITIONS Not applicable 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 LID Carros France 16. MARKETING AUTHORISATION NUMBER(S) EU/2/06/068/ MANUFACTURER S BATCH NUMBER Batch {number} 12

13 MINIMUM PARTICULARS TO APPEAR ON BLISTERS BLISTER mg 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Ypozane mg tablets for dogs Osaterone acetate 2. NAME OF THE MARKETING AUTHORISATION HOLDER 3. EXPIRY DATE EXP {month/year} 4. BATCH NUMBER Batch {number} 5. THE WORDS FOR ANIMAL TREATMENT ONLY For animal treatment only. 13

14 PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX mg 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Ypozane 3.75 mg tablets for dogs Osaterone acetate 2. STATEMENT OF ACTIVE SUBSTANCES Each tablet contains 3.75 mg osaterone acetate 3. PHARMACEUTICAL FORM Tablet. 4. PACKAGE SIZE 7 tablets. 5. TARGET SPECIES Dogs. 6. INDICATION(S) Treatment of benign prostatic hypertrophy in male dogs. 7. METHOD AND ROUTE(S) OF ADMINISTRATION Oral use. Read the package leaflet before use. 8. WITHDRAWAL PERIOD(S) Not applicable 9. SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use. 14

15 10. EXPIRY DATE EXP {month/year} 11. SPECIAL STORAGE CONDITIONS Not applicable 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 LID Carros France 16. MARKETING AUTHORISATION NUMBER(S) EU/2/06/068/ MANUFACTURER S BATCH NUMBER Batch {number} 15

16 MINIMUM PARTICULARS TO APPEAR ON BLISTERS BLISTER mg 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Ypozane 3.75 mg tablets for dogs Osaterone acetate 2. NAME OF THE MARKETING AUTHORISATION HOLDER 3. EXPIRY DATE EXP {month/year} 4. BATCH NUMBER Batch {number} 5. THE WORDS FOR ANIMAL TREATMENT ONLY For animal treatment only. 16

17 PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX mg 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Ypozane 7.5 mg tablets for dogs Osaterone acetate 2. STATEMENT OF ACTIVE SUBSTANCES Each tablet contains 7.5 mg osaterone acetate 3. PHARMACEUTICAL FORM Tablet. 4. PACKAGE SIZE 7 tablets. 5. TARGET SPECIES Dogs. 6. INDICATION(S) Treatment of benign prostatic hypertrophy in male dogs. 7. METHOD AND ROUTE(S) OF ADMINISTRATION Oral use. Read the package leaflet before use. 8. WITHDRAWAL PERIOD(S) Not applicable 9. SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use. 17

18 10. EXPIRY DATE EXP {month/year} 11. SPECIAL STORAGE CONDITIONS Not applicable 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 LID Carros France 16. MARKETING AUTHORISATION NUMBER(S) EU/2/06/068/ MANUFACTURER S BATCH NUMBER Batch {number} 18

19 MINIMUM PARTICULARS TO APPEAR ON BLISTERS BLISTER mg 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Ypozane 7.5 mg tablets for dogs Osaterone acetate 2. NAME OF THE MARKETING AUTHORISATION HOLDER 3. EXPIRY DATE EXP {month/year} 4. BATCH NUMBER Batch {number} 5. THE WORDS FOR ANIMAL TREATMENT ONLY For animal treatment only. 19

20 PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX - 15 mg 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Ypozane 15 mg tablets for dogs Osaterone acetate 2. STATEMENT OF ACTIVE SUBSTANCES Each tablet contains 15 mg osaterone acetate 3. PHARMACEUTICAL FORM Tablet. 4. PACKAGE SIZE 7 tablets. 5. TARGET SPECIES Dogs. 6. INDICATION(S) Treatment of benign prostatic hypertrophy in male dogs. 7. METHOD AND ROUTE(S) OF ADMINISTRATION Oral use. Read the package leaflet before use. 8. WITHDRAWAL PERIOD(S) Not applicable 9. SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use. 20

21 10. EXPIRY DATE EXP {month/year} 11. SPECIAL STORAGE CONDITIONS Not applicable 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 LID Carros France 16. MARKETING AUTHORISATION NUMBER(S) EU/2/06/068/ MANUFACTURER S BATCH NUMBER Batch {number} 21

22 MINIMUM PARTICULARS TO APPEAR ON BLISTERS BLISTER - 15 mg 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Ypozane 15 mg tablets for dogs Osaterone acetate 2. NAME OF THE MARKETING AUTHORISATION HOLDER 3. EXPIRY DATE EXP {month/year} 4. BATCH NUMBER Batch {number} 5. THE WORDS FOR ANIMAL TREATMENT ONLY For animal treatment only. 22

23 B. PACKAGE LEAFLET 23

24 PACKAGE LEAFLET YPOZANE 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE Marketing authorisation holder and manufacturer: 1ère avenue 2065 m LID Carros France 2. NAME OF THE VETERINARY MEDICINAL PRODUCT YPOZANE mg tablets for dogs YPOZANE 3.75 mg tablets for dogs YPOZANE 7.5 mg tablets for dogs YPOZANE 15 mg tablets for dogs Osaterone acetate 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each tablet contains mg, 3.75 mg, 7.5 mg or 15 mg osaterone acetate 4. INDICATION(S) Treatment of benign prostatic hypertrophy in male dogs. 5. CONTRAINDICATIONS None. 6. ADVERSE REACTIONS The most commonly reported adverse reactions are mild and transient modifications of appetite, either increased (very common) or decreased (very rare). Behavioural changes such as modification of dog s activity or more social behaviour are common. Other adverse reactions such as transient vomiting and/or diarrhoea, increased thirst or lethargy occur less commonly. The enlargement of mammary glands occurs less commonly and can be associated with lactaction in very rare cases. Transient side-effects of changes in the hair coat such as hair loss or hair modification have been seen very rarely following administration of Ypozane. All these adverse reactions are reversible without any specific treatment. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated ) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) 24

25 - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports). If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon. 7. TARGET SPECIES Dogs (male) 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION For oral use. Administer mg osaterone acetate per kilogram bodyweight, once a day, for 7 days as follows: Dog s weight YPOZANE tablets to be administered 3 to 7.5 kg mg tablet 7.5 to 15 kg 3.75 mg tablet 15 to 30 kg 7.5 mg tablet kg 15 mg tablet Number of tablet per day Treatment duration 1 tablet 7 days 9. ADVICE ON CORRECT ADMINISTRATION Tablets can be given either directly into the mouth or with food. The onset of clinical response to treatment is usually seen within 2 weeks and persists for at least 5 months after treatment. Re-evaluation by the veterinarian should take place 5 months after treatment, or earlier if clinical signs recur. A decision to retreat at this or at a later time point should be based on veterinary examination taking into account the risk benefit profile of the medicine. If clinical response to treatment is considerably shorter than expected, a re-evaluation of the diagnosis is necessary. The maximum dose should not be exceeded. 10. WITHDRAWAL PERIOD(S) 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 blister after EXP 25

26 12. SPECIAL WARNING(S) Use with caution in dogs with a history of liver disease. Wash hands after administration. In the case of accidental ingestion by a person, seek medical advice immediately and show the package leaflet or the label to the physician. A single oral dose of 40 mg osaterone acetate in human males was followed by a sporadic decrease of sexual hormones, reversible after 16 days. There was no clinical effect. In female laboratory animals, osaterone acetate caused serious adverse effects on reproductive functions. Therefore, women of child bearing age should avoid contact with, or wear disposable gloves, when administering the product. 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment. 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED : Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency ( 15. OTHER INFORMATION Benign prostatic hypertrophy (BPH) is a natural consequence of ageing. Over 80% of male dogs above 5 years of age are affected. BPH is a development and enlargement of the prostate due to the male hormone testosterone. This might lead to multiple non-specific clinical signs such as abdominal pain, difficulties in defaecation and urination, blood in urine and locomotive disorders. België/Belgique/Belgien VIRBAC BELGIUM S.A. B-3001 Leuven Tel: 32 (0) Česká republika 1 ère avenue 2065 m L.I.D F Carros Tel: 33 (0) Danmark VIRBAC Danmark A/S Profilvej Kolding Tel: Deutschland VIRBAC Tierarzneimittel GmbH Rögen 20 Luxembourg/Luxemburg VIRBAC BELGIUM S.A. B-3001 Leuven Tel: 32 (0) Magyarország 1 ère avenue 2065 m L.I.D F Carros Tel: 33 (0) Malta 1 ère avenue 2065 m L.I.D F Carros Tel: 33 (0) Nederland VIRBAC NEDERLAND BV Postbus

27 D Bad Oldesloe Tel: 49 (4531) Eesti OÜ ZOOVETVARU Uusaru 5 ET Saue/Harjumaa, ESTONIA Tel: margus@zoovet.ee Ελλάδα VIRBAC HELLAS A.E. 23 rd Klm National Road Athens-Lamia Agios Stefanos Athens GREECE Tel: info@virbac.gr España VIRBAC ESPAÑA, S.A. E Esplugues de Llobregat (Barcelona) Tel: France VIRBAC 13 ème rue L.I.D BP 27 F Carros Ireland VIRBAC 1ère avenue 2065 m LID Carros France Tel: + 33 (0) Ísland 1 ère avenue 2065 m L.I.D F Carros Tel: 33 (0) Italia VIRBAC SRL Via Caldera, 21 I Milano Tel: Κύπρος Panchris Feeds (Veterinary) Ltd Industrial Area Aradippou, 7100, Larnaca, Cyprus (P.O.Box 40261, 6302 Larnaca, Cyprus) Tel: Latvija OÜ ZOOVETVARU Uusaru 5 ET Saue/Harjumaa, ESTONIA Tel: margus@zoovet.ee NL-3771 AH-Barneveld Tel: 31 (0) Norge 1 ère avenue 2065 m L.I.D F Carros Tel: 33 (0) Österreich VIRBAC Österreich GmbH Hildebrandgasse 27 A-1180 Wien Tel: 43 (0) Polska VIRBAC Sp. o.o. ul. Puławska Warszawa Portugal VIRBAC DE Portugal LABORATÓRIOS LDA Ed13-Piso 1- Esc.3 Quinta da Beloura Sintra Slovenija 1 ère avenue 2065 m L.I.D F Carros Tel: 33 (0) Slovenská republika 1 ère avenue 2065 m L.I.D F Carros Tel: 33 (0) Suomi/Finland 1 ère avenue 2065 m L.I.D F Carros Tel: 33 (0) Sverige 1 ère avenue 2065 m L.I.D F Carros Tel: 33 (0) United Kingdom VIRBAC Ltd UK-Suffolk IP30 9 UP Tel: 44 (0)

28 Lietuva OÜ ZOOVETVARU Uusaru 5 ET Saue/Harjumaa, ESTONIA Tel: margus@zoovet.ee România 1 ère avenue 2065 m L.I.D F Carros Tel: 33 (0) Република България 1 ère avenue 2065 m L.I.D F Carros Tel: 33 (0) Hrvatska 1 ère avenue 2065 m L.I.D F Carros Tel: 33 (0)