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Edistride (dapagliflozin propanediol monohydrate) – Labelling - A10BX09

Updated on site: 06-Oct-2017

Medication nameEdistride
ATC CodeA10BX09
Substancedapagliflozin propanediol monohydrate
ManufacturerAstraZeneca AB

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON 5 mg

1.NAME OF THE MEDICINAL PRODUCT

Edistride 5 mg film-coated tablets dapagliflozin

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin.

3.LIST OF EXCIPIENTS

Contains lactose. See package leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

14 film-coated tablets

28 film-coated tablets

30x1 film-coated tablets

90x1 film-coated tablets

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/1/15/1052/001 14 film-coated tablets

EU/1/15/1052/002 28 film-coated tablets

EU/1/15/1052/003 98 film-coated tablets

EU/1/15/1052/004 30 x 1 (unit dose) film-coated tablets

EU/1/15/1052/005 90 x 1 (unit dose) film-coated tablets

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

edistride 5 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 10 mg

1. NAME OF THE MEDICINAL PRODUCT

Edistride 10 mg film-coated tablets dapagliflozin

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains dapagliflozin propanediol monohydrate equivalent to 10 mg dapagliflozin.

3. LIST OF EXCIPIENTS

Contains lactose. See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

14 film-coated tablets

28 film-coated tablets

30x1 film-coated tablets

90x1 film-coated tablets

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/1/15/1052/006 14 film-coated tablets

EU/1/15/1052/007 28 film-coated tablets

EU/1/15/1052/008 98 film-coated tablets

EU/1/15/1052/009 30 x 1 (unit dose) film-coated tablets

EU/1/15/1052/010 90 x 1 (unit dose) film-coated tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

edistride 10 mg

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 BLISTERS PERFORATED UNIT DOSE 5 mg

1. NAME OF THE MEDICINAL PRODUCT

Edistride 5 mg tablets dapagliflozin

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 PERFORATED UNIT DOSE 10 mg

1. NAME OF THE MEDICINAL PRODUCT

Edistride 10 mg tablets dapagliflozin

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 CALENDAR BLISTERS NON-PERFORATED 5 mg

1. NAME OF THE MEDICINAL PRODUCT

Edistride 5 mg tablets dapagliflozin

2. NAME OF THE MARKETING AUTHORISATION HOLDER

AstraZeneca AB

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

Monday Tuesday Wednesday Thursday Friday Saturday Sunday

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS CALENDAR BLISTERS NON-PERFORATED 10 mg

1. NAME OF THE MEDICINAL PRODUCT

Edistride 10 mg tablets dapagliflozin

2. NAME OF THE MARKETING AUTHORISATION HOLDER

AstraZeneca AB

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

Monday Tuesday Wednesday Thursday Friday Saturday Sunday

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