Ypozane (osaterone acetate) – Labelling - QG04CX90

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

BOX - 1.875 mg

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

Ypozane 1.875 mg tablets for dogs

Osaterone acetate

2.STATEMENT OF ACTIVE AND OTHER SUBSTANCES

Each tablet contains 1.875 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

Not applicable

9.SPECIAL WARNING(S), IF NECESSARY

Read the package leaflet before use.

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.

1ère avenue – 2065 m – LID

06516 Carros France

16.MARKETING AUTHORISATION NUMBER(S)

EU/2/06/068/001

17.MANUFACTURER’S BATCH NUMBER

Batch {number}

MINIMUM PARTICULARS TO APPEAR ON BLISTERS

BLISTER - 1.875 mg

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Ypozane 1.875 mg tablets for dogs

Osaterone acetate

2.NAME OF THE MARKETING AUTHORISATION HOLDER

VIRBAC S.A.

3.EXPIRY DATE

EXP {month/year}

4.BATCH NUMBER

Batch {number}

5.THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

BOX - 3.75 mg

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Ypozane 3.75 mg tablets for dogs

Osaterone acetate

2. STATEMENT OF ACTIVE AND OTHER 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

Not applicable

9. SPECIAL WARNING(S), IF NECESSARY

Read the package leaflet before use.

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.

1ère avenue – 2065 m – LID

06516 Carros France

16. MARKETING AUTHORISATION NUMBER(S)

EU/2/06/068/002

17. MANUFACTURER’S BATCH NUMBER

Batch {number}

MINIMUM PARTICULARS TO APPEAR ON BLISTERS

BLISTER - 3.75 mg

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Ypozane 3.75 mg tablets for dogs

Osaterone acetate

2. NAME OF THE MARKETING AUTHORISATION HOLDER

VIRBAC S.A.

3. EXPIRY DATE

EXP {month/year}

4. BATCH NUMBER

Batch {number}

5. THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

BOX - 7.5 mg

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Ypozane 7.5 mg tablets for dogs

Osaterone acetate

2. STATEMENT OF ACTIVE AND OTHER 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

Not applicable

9. SPECIAL WARNING(S), IF NECESSARY

Read the package leaflet before use.

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.

1ère avenue – 2065 m – LID

06516 Carros France

16. MARKETING AUTHORISATION NUMBER(S)

EU/2/06/068/003

17. MANUFACTURER’S BATCH NUMBER

Batch {number}

MINIMUM PARTICULARS TO APPEAR ON BLISTERS

BLISTER - 7.5 mg

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Ypozane 7.5 mg tablets for dogs

Osaterone acetate

2. NAME OF THE MARKETING AUTHORISATION HOLDER

VIRBAC S.A.

3. EXPIRY DATE

EXP {month/year}

4. BATCH NUMBER

Batch {number}

5. THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

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 AND OTHER 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

Not applicable

9. SPECIAL WARNING(S), IF NECESSARY

Read the package leaflet before use.

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.

1ère avenue – 2065 m – LID

06516 Carros France

16. MARKETING AUTHORISATION NUMBER(S)

EU/2/06/068/004

17. MANUFACTURER’S BATCH NUMBER

Batch {number}

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

VIRBAC S.A.

3. EXPIRY DATE

EXP {month/year}

4. BATCH NUMBER

Batch {number}

5. THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

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