Masivet (masitinib mesylate) – Labelling - QL01XE90

Updated on site: 09-Feb-2018

Medication name: Masivet
ATC: QL01XE90
Substance: masitinib mesylate
Manufacturer: AB Science S.A.

Article Contents

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

Carton Box Labelling

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

MASIVET 50 mg film-coated tablets for dogs

Masitinib

2.STATEMENT OF ACTIVE AND OTHER SUBSTANCES

Masitinib 50 mg

3.PHARMACEUTICAL FORM

Film coated tablet

4.PACKAGE SIZE

30 tablets

5.TARGET SPECIES

Dogs

6.INDICATION(S)

7.METHOD AND ROUTE(S) OF ADMINISTRATION

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

Keep the bottle tightly closed.

12.SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY

Disposal: read package leaflet.

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 sight and reach of children.

15.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

AB Science

3 avenue George V FR-75008

Paris

France

16.MARKETING AUTHORISATION NUMBER(S)

EU/2/08/087/001

EU/2/08/087/003

17.MANUFACTURER’S BATCH NUMBER

Lot {number}

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGE UNITS

Label

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

MASIVET 50 mg film-coated tablets for dogs

Masitinib

2.QUANTITY OF THE ACTIVE SUBSTANCE(S)

Masitinib 50 mg

3.CONTENTS

30 tablets

4.ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

5.WITHDRAWAL PERIOD

Not applicable

6.BATCH NUMBER

Lot {number}

7.EXPIRY DATE

EXP {month/year}

8.THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

Carton Box Labelling

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

MASIVET 150 mg film-coated tablets for dogs

Masitinib

2.STATEMENT OF ACTIVE AND OTHER SUBSTANCES

Masitinib 150 mg

3.PHARMACEUTICAL FORM

Film coated tablet

4.PACKAGE SIZE

30 tablets

5.TARGET SPECIES

Dogs

6.INDICATION(S)

7.METHOD AND ROUTE(S) OF ADMINISTRATION

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

Keep the bottle tightly closed.

12.SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY

Disposal: read package leaflet.

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 sight and reach of children.

15.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

AB Science

3 avenue George V FR-75008 Paris France

16.MARKETING AUTHORISATION NUMBER(S)

EU/2/08/087/002

17.MANUFACTURER’S BATCH NUMBER

Lot {number}

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGE UNITS

Label

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

MASIVET 150 mg film-coated tablets for dogs

Masitinib

2.QUANTITY OF THE ACTIVE SUBSTANCE(S)

Masitinib 150 mg

3.CONTENTS

30 tablets

4.ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

5.WITHDRAWAL PERIOD

Not applicable.

5.BATCH NUMBER

Lot {number}

6.EXPIRY DATE

EXP {month/year}

8.THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

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