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Exforge (amlodipine (as besylate) / valsartan) – Labelling - C09DB01

Updated on site: 06-Oct-2017

Medication nameExforge
ATC CodeC09DB01
Substanceamlodipine (as besylate) / valsartan
ManufacturerNovartis Europharm Ltd

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF UNIT PACK

1.NAME OF THE MEDICINAL PRODUCT

Exforge 5 mg/80 mg film-coated tablets amlodipine/valsartan

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 5 mg amlodipine (as amlodipine besylate) and 80 mg valsartan.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

7 film-coated tablets

14 film-coated tablets

28 film-coated tablets

30 film-coated tablets

56 film-coated tablets

90 film-coated tablets

98 film-coated tablets

280 film-coated tablets

56x1 film-coated tablet (unit dose)

98x1 film-coated tablet (unit dose)

280x1 film-coated tablet (unit dose)

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral 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.

Store in the original package in order to protect from moisture.

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

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/06/370/001

7 film-coated tablets

 

 

 

 

EU/1/06/370/002

14 film-coated tablets

 

 

 

EU/1/06/370/003

28 film-coated tablets

 

 

 

EU/1/06/370/004

30 film-coated tablets

 

 

 

EU/1/06/370/005

56 film-coated tablets

 

 

 

EU/1/06/370/006

90 film-coated tablets

 

 

 

EU/1/06/370/007

98 film-coated tablets

 

 

 

EU/1/06/370/008

280 film-coated tablets

 

 

EU/1/06/370/025

56x1 film-coated tablet (unit dose)

 

EU/1/06/370/026

98x1 film-coated tablet (unit dose)

 

EU/1/06/370/027

280x1 film-coated tablet (unit dose)

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Exforge 5 mg/80 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Exforge 5 mg/80 mg film-coated tablets amlodipine/valsartan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 5 mg amlodipine (as amlodipine besylate) and 80 mg valsartan.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

70 film-coated tablets. Component of a multipack, not to be sold separately. 14 film-coated tablets. Component of a multipack, not to be sold separately.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral 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.

Store in the original package in order to protect from moisture.

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

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

12.

MARKETING AUTHORISATION NUMBER(S)

 

 

 

 

EU/1/06/370/034

280 film-coated tablets (4x70)

 

 

 

EU/1/06/370/037

280 film-coated tablets (20x14)

 

 

 

13.

BATCH NUMBER

 

 

 

 

 

Lot

 

 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Exforge 5 mg/80 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON OF MULTIPACK (WITH BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Exforge 5 mg/80 mg film-coated tablets amlodipine/valsartan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 5 mg amlodipine (as amlodipine besylate) and 80 mg valsartan.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Multipack: 280 (4 packs of 70) film-coated tablets

Multipack: 280 (20 packs of 14) film-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral 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.

Store in the original package in order to protect from moisture.

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

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

12.

MARKETING AUTHORISATION NUMBER(S)

 

 

 

 

EU/1/06/370/034

280 film-coated tablets (4x70)

 

 

 

EU/1/06/370/037

280 film-coated tablets (20x14)

 

 

 

13.

BATCH NUMBER

 

 

 

 

 

Lot

 

 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Exforge 5 mg/80 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

Exforge 5 mg/80 mg film-coated tablets amlodipine/valsartan

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF UNIT PACK

1. NAME OF THE MEDICINAL PRODUCT

Exforge 5 mg/160 mg film-coated tablets amlodipine/valsartan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 5 mg amlodipine (as amlodipine besylate) and 160 mg valsartan.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

7 film-coated tablets

14 film-coated tablets

28 film-coated tablets

30 film-coated tablets

56 film-coated tablets

90 film-coated tablets

98 film-coated tablets

280 film-coated tablets

56x1 film-coated tablet (unit dose)

98x1 film-coated tablet (unit dose)

280x1 film-coated tablet (unit dose)

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral 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.

Store in the original package in order to protect from moisture.

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

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/06/370/009

7 film-coated tablets

 

 

 

 

EU/1/06/370/010

14 film-coated tablets

 

 

 

EU/1/06/370/011

28 film-coated tablets

 

 

 

EU/1/06/370/012

30 film-coated tablets

 

 

 

EU/1/06/370/013

56 film-coated tablets

 

 

 

EU/1/06/370/014

90 film-coated tablets

 

 

 

EU/1/06/370/015

98 film-coated tablets

 

 

 

EU/1/06/370/016

280 film-coated tablets

 

 

EU/1/06/370/028

56x1 film-coated tablet (unit dose)

 

EU/1/06/370/029

98x1 film-coated tablet (unit dose)

 

EU/1/06/370/030

280x1 film-coated tablet (unit dose)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Exforge 5 mg/160 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Exforge 5 mg/160 mg film-coated tablets amlodipine/valsartan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 5 mg amlodipine (as amlodipine besylate) and 160 mg valsartan.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

70 film-coated tablets. Component of a multipack, not to be sold separately. 14 film-coated tablets. Component of a multipack, not to be sold separately.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral 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.

Store in the original package in order to protect from moisture.

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

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

12.

MARKETING AUTHORISATION NUMBER(S)

 

 

 

 

EU/1/06/370/035

280 film-coated tablets (4x70)

 

 

 

EU/1/06/370/038

280 film-coated tablets (20x14)

 

 

 

13.

BATCH NUMBER

 

 

 

 

 

Lot

 

 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Exforge 5 mg/160 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON OF MULTIPACK (WITH BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Exforge 5 mg/160 mg film-coated tablets amlodipine/valsartan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 5 mg amlodipine (as amlodipine besylate) and 160 mg valsartan.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Multipack: 280 (4 packs of 70) film-coated tablets

Multipack: 280 (20 packs of 14) film-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral 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.

Store in the original package in order to protect from moisture.

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

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

12.

MARKETING AUTHORISATION NUMBER(S)

 

 

 

 

EU/1/06/370/035

280 film-coated tablets (4x70)

 

 

 

EU/1/06/370/038

280 film-coated tablets (20x14)

 

 

 

13.

BATCH NUMBER

 

 

 

 

 

Lot

 

 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Exforge 5 mg/160 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

Exforge 5 mg/160 mg film-coated tablets amlodipine/valsartan

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF UNIT PACK

1. NAME OF THE MEDICINAL PRODUCT

Exforge 10 mg/160 mg film-coated tablets amlodipine/valsartan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 10 mg amlodipine (as amlodipine besylate) and 160 mg valsartan.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

7 film-coated tablets

14 film-coated tablets

28 film-coated tablets

30 film-coated tablets

56 film-coated tablets

90 film-coated tablets

98 film-coated tablets

280 film-coated tablets

56x1 film-coated tablet (unit dose)

98x1 film-coated tablet (unit dose)

280x1 film-coated tablet (unit dose)

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral 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.

Store in the original package in order to protect from moisture.

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

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/06/370/017

7 film-coated tablets

 

 

 

 

EU/1/06/370/018

14 film-coated tablets

 

 

 

EU/1/06/370/019

28 film-coated tablets

 

 

 

EU/1/06/370/020

30 film-coated tablets

 

 

 

EU/1/06/370/021

56 film-coated tablets

 

 

 

EU/1/06/370/022

90 film-coated tablets

 

 

 

EU/1/06/370/023

98 film-coated tablets

 

 

 

EU/1/06/370/024

280 film-coated tablets

 

 

EU/1/06/370/031

56x1 film-coated tablet (unit dose)

 

EU/1/06/370/032

98x1 film-coated tablet (unit dose)

 

EU/1/06/370/033

280x1 film-coated tablet (unit dose)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Exforge 10 mg/160 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Exforge 10 mg/160 mg film-coated tablets amlodipine/valsartan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 10 mg amlodipine (as amlodipine besylate) and 160 mg valsartan.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

70 film-coated tablets. Component of a multipack, not to be sold separately. 14 film-coated tablets. Component of a multipack, not to be sold separately.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral 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.

Store in the original package in order to protect from moisture.

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

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

12.

MARKETING AUTHORISATION NUMBER(S)

 

 

 

 

EU/1/06/370/036

280 film-coated tablets (4x70)

 

 

 

EU/1/06/370/039

280 film-coated tablets (20x14)

 

 

 

13.

BATCH NUMBER

 

 

 

 

 

Lot

 

 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Exforge 10 mg/160 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON OF MULTIPACK (WITH BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Exforge 10 mg/160 mg film-coated tablets amlodipine/valsartan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 10 mg amlodipine (as amlodipine besylate) and 160 mg valsartan.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Multipack: 280 (4 packs of 70) film-coated tablets

Multipack: 280 (20 packs of 14) film-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral 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.

Store in the original package in order to protect from moisture.

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

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

12.

MARKETING AUTHORISATION NUMBER(S)

 

 

 

 

EU/1/06/370/036

280 film-coated tablets (4x70)

 

 

 

EU/1/06/370/039

280 film-coated tablets (20x14)

 

 

 

13.

BATCH NUMBER

 

 

 

 

 

Lot

 

 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Exforge 10 mg/160 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

Exforge 10 mg/160 mg film-coated tablets amlodipine/valsartan

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

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