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Karvea (irbesartan) – Labelling - C09CA04

Updated on site: 08-Oct-2017

Medication nameKarvea
ATC CodeC09CA04
Substanceirbesartan
ManufacturerSanofi-aventis groupe

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

Karvea 75 mg tablets irbesartan

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains: irbesartan 75 mg

3.LIST OF EXCIPIENTS

Excipients: also contains lactose monohydrate.

4.PHARMACEUTICAL FORM AND CONTENTS

14 tablets

28 tablets

56 tablets

56 x 1 tablets

98 tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use. Read the package leaflet before use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7.OTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

sanofi-aventis groupe 54, rue La Boétie F-75008 Paris - France

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/97/049/010 - 14 tablets

EU/1/97/049/001 - 28 tablets

EU/1/97/049/002 - 56 tablets

EU/1/97/049/013 - 56 x 1 tablets

EU/1/97/049/003 - 98 tablets

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Karvea 75 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

1. NAME OF THE MEDICINAL PRODUCT

Karvea 75 mg tablets irbesartan

2.NAME OF THE MARKETING AUTHORISATION HOLDER

sanofi-aventis groupe

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

14 - 28 - 56 - 98 tablets: Mon

Tue

Wed

Thu

Fri

Sat

Sun

56 x 1 tablets:

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Karvea 150 mg tablets irbesartan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains: irbesartan 150 mg

3. LIST OF EXCIPIENTS

Excipients: also contains lactose monohydrate.

4. PHARMACEUTICAL FORM AND CONTENTS

14 tablets

28 tablets

56 tablets

56 x 1 tablets

98 tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use. Read the package leaflet before use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

sanofi-aventis groupe 54, rue La Boétie F-75008 Paris - France

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/97/049/011 - 14 tablets

EU/1/97/049/004 - 28 tablets

EU/1/97/049/005 - 56 tablets

EU/1/97/049/014 - 56 x 1 tablets

EU/1/97/049/006 - 98 tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Karvea 150 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

1. NAME OF THE MEDICINAL PRODUCT

Karvea 150 mg tablets irbesartan

2. NAME OF THE MARKETING AUTHORISATION HOLDER

sanofi-aventis groupe

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

14 - 28 - 56 - 98 tablets: Mon

Tue

Wed

Thu

Fri

Sat

Sun

56 x 1 tablets:

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Karvea 300 mg tablets irbesartan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains: irbesartan 300 mg

3. LIST OF EXCIPIENTS

Excipients: also contains lactose monohydrate.

4. PHARMACEUTICAL FORM AND CONTENTS

14 tablets

28 tablets

56 tablets

56 x 1 tablets

98 tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use. Read the package leaflet before use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

sanofi-aventis groupe 54, rue La Boétie F-75008 Paris - France

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/97/049/012 - 14 tablets

EU/1/97/049/007 - 28 tablets

EU/1/97/049/008 - 56 tablets

EU/1/97/049/015 - 56 x 1 tablets

EU/1/97/049/009 - 98 tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Karvea 300 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

1. NAME OF THE MEDICINAL PRODUCT

Karvea 300 mg tablets irbesartan

2. NAME OF THE MARKETING AUTHORISATION HOLDER

sanofi-aventis groupe

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

14 - 28 - 56 - 98 tablets: Mon

Tue

Wed

Thu

Fri

Sat

Sun

56 x 1 tablets:

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Karvea 75 mg film-coated tablets irbesartan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains: irbesartan 75 mg

3. LIST OF EXCIPIENTS

Excipients: also contains lactose monohydrate.

4. PHARMACEUTICAL FORM AND CONTENTS

14 tablets

28 tablets

30 tablets

56 tablets

56 x 1 tablets

84 tablets

90 tablets

98 tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use. Read the package leaflet before use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

sanofi-aventis groupe 54, rue La Boétie F-75008 Paris - France

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/97/049/016 - 14 tablets

EU/1/97/049/017 - 28 tablets

EU/1/97/049/034 - 30 tablets

EU/1/97/049/018 - 56 tablets

EU/1/97/049/019 - 56 x 1 tablets

EU/1/97/049/031 - 84 tablets

EU/1/97/049/037 - 90 tablets

EU/1/97/049/020 - 98 tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Karvea 75 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

1. NAME OF THE MEDICINAL PRODUCT

Karvea 75 mg tablets irbesartan

2. NAME OF THE MARKETING AUTHORISATION HOLDER

sanofi-aventis groupe

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

14 - 28 - 56 - 84 - 98 tablets: Mon

Tue

Wed

Thu

Fri

Sat

Sun

30 - 56 x 1 - 90 tablets:

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Karvea 150 mg film-coated tablets irbesartan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains: irbesartan 150 mg

3. LIST OF EXCIPIENTS

Excipients: also contains lactose monohydrate.

4. PHARMACEUTICAL FORM AND CONTENTS

14 tablets

28 tablets

30 tablets

56 tablets

56 x 1 tablets

84 tablets

90 tablets

98 tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use. Read the package leaflet before use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

sanofi-aventis groupe 54, rue La Boétie F-75008 Paris - France

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/97/049/021 - 14 tablets

EU/1/97/049/022 - 28 tablets

EU/1/97/049/035 - 30 tablets

EU/1/97/049/023 - 56 tablets

EU/1/97/049/024 - 56 x 1 tablets

EU/1/97/049/032 - 84 tablets

EU/1/97/049/038 - 90 tablets

EU/1/97/049/025 - 98 tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Karvea 150 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

1. NAME OF THE MEDICINAL PRODUCT

Karvea 150 mg tablets irbesartan

2. NAME OF THE MARKETING AUTHORISATION HOLDER

sanofi-aventis groupe

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

14 - 28 - 56 - 84 - 98 tablets: Mon

Tue

Wed

Thu

Fri

Sat

Sun

30 - 56 x 1 - 90 tablets:

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Karvea 300 mg film-coated tablets irbesartan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains: irbesartan 300 mg

3. LIST OF EXCIPIENTS

Excipients: also contains lactose monohydrate.

4. PHARMACEUTICAL FORM AND CONTENTS

14 tablets

28 tablets

30 tablets

56 tablets

56 x 1 tablets

84 tablets

90 tablets

98 tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use. Read the package leaflet before use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

sanofi-aventis groupe 54, rue La Boétie F-75008 Paris - France

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/97/049/026 - 14 tablets

EU/1/97/049/027 - 28 tablets

EU/1/97/049/036 - 30 tablets

EU/1/97/049/028 - 56 tablets

EU/1/97/049/029 - 56 x 1 tablets

EU/1/97/049/033 - 84 tablets

EU/1/97/049/039 - 90 tablets

EU/1/97/049/030 - 98 tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Karvea 300 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

1. NAME OF THE MEDICINAL PRODUCT

Karvea 300 mg tablets irbesartan

2. NAME OF THE MARKETING AUTHORISATION HOLDER

sanofi-aventis groupe

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

14 - 28 - 56 - 84 - 98 tablets: Mon

Tue

Wed

Thu

Fri

Sat

Sun

30 - 56 x 1 - 90 tablets:

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