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Irbesartan Teva (irbesartan) – Labelling - C09CA04

Updated on site: 08-Oct-2017

Medication nameIrbesartan Teva
ATC CodeC09CA04
Substanceirbesartan
ManufacturerTeva B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

Irbesartan Teva 75 mg film-coated tablets

Irbesartan

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 75 mg irbesartan

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablets

7 film-coated tablets

14 film-coated tablets

28 film-coated tablets

30 film-coated tablets

56 film-coated tablets

60 film-coated tablets

80 film-coated tablets

84 film-coated tablets

90 film-coated tablets

98 film-coated tablets

100 film-coated tablets

50 x 1 film-coated tablets

56 x 1 film-coated 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

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

Teva B.V.

Swensweg 5

2031GA Haarlem

The Netherlands

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/09/576/001 7 tablets

EU/1/09/576/002 14 tablets

EU/1/09/576/003 28 tablets

EU/1/09/576/004 30 tablets

EU/1/09/576/005 56 tablets

EU/1/09/576/006 60 tablets

EU/1/09/576/007 80 tablets

EU/1/09/576/008 84 tablets

EU/1/09/576/009 90 tablets

EU/1/09/576/010 98 tablets

EU/1/09/576/011 100 tablets

EU/1/09/576/012 50 x 1 tablet (unit dose)

EU/1/09/576/013 56 x 1 tablet (unit dose)

EU/1/09/576/040 28 tablets (calendar pack)

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Irbesartan Teva 75 mg film-coated tablets

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

1. NAME OF THE MEDICINAL PRODUCT

Irbesartan Teva 75 mg film-coated tablets

Irbesartan

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Teva B.V.

3.EXPIRY DATE

EXP

4.BATCH NUMBER

LOT

5.OTHER

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

CALENDAR BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Irbesartan Teva 75 mg film-coated tablets

Irbesartan

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Teva B.V.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

LOT

5. OTHER

Monday Tuesday Wednesday Thursday Friday Saturday Sunday

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Irbesartan Teva 150 mg film-coated tablets

Irbesartan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 150 mg irbesartan

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablets

7 film-coated tablets

14 film-coated tablets

28 film-coated tablets

30 film-coated tablets

56 film-coated tablets

60 film-coated tablets

80 film-coated tablets

84 film-coated tablets

90 film-coated tablets

98 film-coated tablets

100 film-coated tablets

50 x 1 film-coated tablets

56 x 1 film-coated 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

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

Teva B.V.

Swensweg 5

2031GA Haarlem

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/09/576/014 7 tablets

EU/1/09/576/015 14 tablets

EU/1/09/576/016 28 tablets

EU/1/09/576/017 30 tablets

EU/1/09/576/018 56 tablets

EU/1/09/576/019 60 tablets

EU/1/09/576/020 80 tablets

EU/1/09/576/021 84 tablets

EU/1/09/576/022 90 tablets

EU/1/09/576/023 98 tablets

EU/1/09/576/024 100 tablets

EU/1/09/576/025 50 x 1 tablet (unit dose)

EU/1/09/576/026 56 x 1 tablet (unit dose)

EU/1/09/576/041 28 tablets (calendar pack)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Irbesartan Teva 150 mg film-coated tablets

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

1. NAME OF THE MEDICINAL PRODUCT

Irbesartan Teva 150 mg film-coated tablets

Irbesartan

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Teva B.V.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

LOT

5. OTHER

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

CALENDAR BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Irbesartan Teva 150 mg film-coated tablets

Irbesartan

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Teva B.V.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

LOT

5. OTHER

Monday Tuesday Wednesday Thursday Friday Saturday Sunday

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Irbesartan Teva 300 mg film-coated tablets

Irbesartan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 300 mg irbesartan

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablets

7 film-coated tablets

14 film-coated tablets

28 film-coated tablets

30 film-coated tablets

56 film-coated tablets

60 film-coated tablets

80 film-coated tablets

84 film-coated tablets

90 film-coated tablets

98 film-coated tablets

100 film-coated tablets

50 x 1 film-coated tablets

56 x 1 film-coated 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

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

Teva B.V.

Swensweg 5

2031GA Haarlem

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/09/576/027 7 tablets

EU/1/09/576/028 14 tablets

EU/1/09/576/029 28 tablets

EU/1/09/576/030 30 tablets

EU/1/09/576/031 56 tablets

EU/1/09/576/032 60 tablets

EU/1/09/576/033 80 tablets

EU/1/09/576/034 84 tablets

EU/1/09/576/035 90 tablets

EU/1/09/576/036 98 tablets

EU/1/09/576/037 100 tablets

EU/1/09/576/038 50 x 1 tablet (unit dose)

EU/1/09/576/039 56 x 1 tablet (unit dose)

EU/1/09/576/042 28 tablets (calendar pack)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Irbesartan Teva 300 mg film-coated tablets

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

1. NAME OF THE MEDICINAL PRODUCT

Irbesartan Teva 300 mg film-coated tablets

Irbesartan

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Teva B.V.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

LOT

5. OTHER

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

CALENDAR BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Irbesartan Teva 300 mg film-coated tablets

Irbesartan

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Teva B.V.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

LOT

5. OTHER

Monday Tuesday Wednesday Thursday Friday Saturday Sunday

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