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Ebymect (dapagliflozin propanediol monohydrate...) – Labelling - A10BD15

Updated on site: 06-Oct-2017

Medication nameEbymect
ATC CodeA10BD15
Substancedapagliflozin propanediol monohydrate / metformin hydrochloride
ManufacturerAstraZeneca AB

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON – WITH BLUE BOX

1.NAME OF THE MEDICINAL PRODUCT

Ebymect 5 mg/850 mg film-coated tablets dapagliflozin/metformin hydrochloride

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 850 mg of metformin hydrochloride.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

14 film-coated tablets

28 film-coated tablets

56 film-coated tablets

60 film-coated tablets 60xl 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

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

AstraZeneca AB

SE-151 85 Södertälje

Sweden

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1051/001

EU/1/15/1051/002

EU/1/15/1051/003

EU/1/15/1051/004

EU/1/15/1051/005

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

ebymect 5 mg/850 mg

17.UNIQUE IDENTIFIER 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER HUMAN READABLE DATA

PC:

SN:

NN:

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON – PART OF MULTIPACK – WITH BLUE BOX

1. NAME OF THE MEDICINAL PRODUCT

Ebymect 5 mg/850 mg film-coated tablets dapagliflozin/metformin hydrochloride

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 850 mg of metformin hydrochloride.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Multipack: 196 (2 packs of 98) 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

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

AstraZeneca AB

SE-151 85 Södertälje

Sweden

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1051/006

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

ebymect 5 mg/850 mg

17. UNIQUE IDENTIFIER 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER HUMAN READABLE DATA

PC:

SN:

NN:

PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING INNER CARTON – PART OF MULTIPACK – WITHOUT BLUE BOX

1. NAME OF THE MEDICINAL PRODUCT

Ebymect 5 mg/850 mg film-coated tablets dapagliflozin/metformin hydrochloride

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 850 mg of metformin hydrochloride.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

98 film-coated tablets. Component of a multipack, can’t 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

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

AstraZeneca AB

SE-151 85 Södertälje

Sweden

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1051/006

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

ebymect 5 mg/850 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON – WITH BLUE BOX

1. NAME OF THE MEDICINAL PRODUCT

Ebymect 5 mg/1,000 mg film-coated tablets dapagliflozin/metformin hydrochloride

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 1,000 mg of metformin hydrochloride.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

14 film-coated tablets

28 film-coated tablets

56 film-coated tablets

60 film-coated tablets

60x1 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

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

AstraZeneca AB

SE-151 85 Södertälje

Sweden

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1051/007

EU/1/15/1051/008

EU/1/15/1051/009

EU/1/15/1051/010

EU/1/15/1051/011

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

ebymect 5 mg/1,000 mg

17. UNIQUE IDENTIFIER 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER HUMAN READABLE DATA

PC:

SN:

NN:

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON – PART OF MULTIPACK – WITH BLUE BOX

1. NAME OF THE MEDICINAL PRODUCT

Ebymect 5 mg/1,000 mg film-coated tablets dapagliflozin/metformin hydrochloride

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 1,000 mg of metformin hydrochloride.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Multipack: 196 (2 packs of 98) 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

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

AstraZeneca AB

SE-151 85 Södertälje

Sweden

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1051/012

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

ebymect 5 mg/1,000 mg

17. UNIQUE IDENTIFIER 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER HUMAN READABLE DATA

PC:

SN:

NN:

PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING INNER CARTON – PART OF MULTIPACK – WITHOUT BLUE BOX

1. NAME OF THE MEDICINAL PRODUCT

Ebymect 5 mg/1,000 mg film-coated tablets dapagliflozin/metformin hydrochloride

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 1,000 mg of metformin hydrochloride.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

98 film-coated tablets. Component of a multipack, can’t 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

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

AstraZeneca AB

SE-151 85 Södertälje

Sweden

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1051/012

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

ebymect 5 mg/1,000 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS (PERFORATED)

1. NAME OF THE MEDICINAL PRODUCT

Ebymect 5 mg/850 mg tablets dapagliflozin/metformin HCl

2.NAME OF THE MARKETING AUTHORISATION HOLDER

AstraZeneca AB

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS (NON-PERFORATED)

1. NAME OF THE MEDICINAL PRODUCT

Ebymect 5 mg/850 mg tablets dapagliflozin/metformin HCl

2. NAME OF THE MARKETING AUTHORISATION HOLDER

AstraZeneca AB

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

10 tablets blister: {Sun/Moon symbol}

14 tablets blister: Mon. Tue. Wed. Thu. Fri. Sat. Sun. {Sun/Moon symbol}

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS (PERFORATED)

1. NAME OF THE MEDICINAL PRODUCT

Ebymect 5 mg/1,000 mg tablets dapagliflozin/metformin HCl

2. NAME OF THE MARKETING AUTHORISATION HOLDER

AstraZeneca AB

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS (NON-PERFORATED)

1. NAME OF THE MEDICINAL PRODUCT

Ebymect 5 mg/1,000 mg tablets dapagliflozin/metformin HCl

2. NAME OF THE MARKETING AUTHORISATION HOLDER

AstraZeneca AB

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

10 tablets blister: {Sun/Moon symbol}

14 tablets blister: Mon. Tue. Wed. Thu. Fri. Sat. Sun. {Sun/Moon symbol}

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