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Daklinza (daclatasvir dihydrochloride) – Labelling - J05AX14

Updated on site: 06-Oct-2017

Medication nameDaklinza
ATC CodeJ05AX14
Substancedaclatasvir dihydrochloride
ManufacturerBristol-Myers Squibb Pharma EEIG

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON TEXT

1.NAME OF THE MEDICINAL PRODUCT

Daklinza 30 mg film-coated tablets daclatasvir

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 30 mg of daclatasvir (as dihydrochloride).

3.LIST OF EXCIPIENTS

Contains lactose.

See package leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

28 film-coated tablets

28 x 1 film-coated tablet

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

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/14/939/001 28 tablets (calendar pack)

EU/1/14/939/002 28 x 1 tablet

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Daklinza 30 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 UNIT DOSE BLISTER (PERFORATED) TEXT

1. NAME OF THE MEDICINAL PRODUCT

Daklinza 30 mg tablets daclatasvir

2.NAME OF THE MARKETING AUTHORISATION HOLDER

BMS

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS CALENDAR BLISTER (NON-PERFORATED) TEXT

1. NAME OF THE MEDICINAL PRODUCT

Daklinza 30 mg tablets daclatasvir

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Bristol-Myers Squibb Pharma EEIG

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 TEXT

1. NAME OF THE MEDICINAL PRODUCT

Daklinza 60 mg film-coated tablets daclatasvir

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 60 mg of daclatasvir (as dihydrochloride).

3. LIST OF EXCIPIENTS

Contains lactose.

See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

28 film-coated tablets

28 x 1 film-coated tablet

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

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/14/939/003 28 tablets (calendar pack)

EU/1/14/939/004 28 x 1 tablet

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Daklinza 60 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 UNIT DOSE BLISTER (PERFORATED) TEXT

1. NAME OF THE MEDICINAL PRODUCT

Daklinza 60 mg tablets daclatasvir

2. NAME OF THE MARKETING AUTHORISATION HOLDER

BMS

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS CALENDAR BLISTER (NON-PERFORATED) TEXT

1. NAME OF THE MEDICINAL PRODUCT

Daklinza 60 mg tablets daclatasvir

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Bristol-Myers Squibb Pharma EEIG

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 TEXT

1. NAME OF THE MEDICINAL PRODUCT

Daklinza 90 mg film-coated tablets daclatasvir

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 90 mg of daclatasvir (as dihydrochloride).

3. LIST OF EXCIPIENTS

Contains lactose.

See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

28 film-coated tablets

28 x 1 film-coated tablet

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

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/14/939/005 28 tablets (calendar pack)

EU/1/14/939/006 28 x 1 tablet

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Daklinza 90 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 UNIT DOSE BLISTER (PERFORATED) TEXT

1. NAME OF THE MEDICINAL PRODUCT

Daklinza 90 mg tablets daclatasvir

2. NAME OF THE MARKETING AUTHORISATION HOLDER

BMS

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS CALENDAR BLISTER (NON-PERFORATED) TEXT

1. NAME OF THE MEDICINAL PRODUCT

Daklinza 90 mg tablets daclatasvir

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Bristol-Myers Squibb Pharma EEIG

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

Monday Tuesday Wednesday Thursday Friday Saturday Sunday

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