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Yentreve (duloxetine hydrochloride) – Labelling - N06AX21

Updated on site: 11-Oct-2017

Medication nameYentreve
ATC CodeN06AX21
Substanceduloxetine hydrochloride
ManufacturerEli Lilly Nederland B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTONS FOR 40 MG HARD GASTRO-RESISTANT CAPSULES

1.NAME OF THE MEDICINAL PRODUCT

YENTREVE 40 mg hard gastro-resistant capsules.

Duloxetine

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each capsule contains 40 mg of duloxetine (as hydrochloride)

3.LIST OF EXCIPIENTS

Contains sucrose

See leaflet for further information

4.PHARMACEUTICAL FORM AND CONTENTS

28 hard gastro-resistant capsules

56 hard gastro-resistant capsules

98 hard gastro-resistant capsules

140 hard gastro-resistant capsules

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

Store in the original package in order to protect from moisture. Do not store above 30°C.

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

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/04/280/002(28 hard gastro-resistant capsules)

EU/1/04/280/003 (56 hard gastro-resistant capsules)

EU/1/04/280/004 (98 hard gastro-resistant capsules)

EU/1/04/280/005 (140 hard gastro-resistant capsules)

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

YENTREVE 40 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

CARTON FOR 98 CAPSULES (40 MG) AS INTERMEDIATE PACK / COMPONENT OF A MULTIPACK (WITHOUT BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

YENTREVE 40 mg hard gastro-resistant capsules.

Duloxetine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each capsule contains 40 mg of duloxetine (as hydrochloride)

3. LIST OF EXCIPIENTS

Contains sucrose

See leaflet for further information

4. PHARMACEUTICAL FORM AND CONTENTS

98 capsules

Component of a multipack comprising 2 packs, each containing 98 capsules.

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

Store in the original package in order to protect from moisture. Do not store above 30 °C

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

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/04/280/006

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

YENTREVE 40 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER WRAPPER LABEL ON MULTIPACKS (2X98 CAPSULES, 40 MG) WRAPPED IN FOIL (INCLUDING BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

YENTREVE 40 mg hard gastro-resistant capsules.

Duloxetine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each capsule contains 40 mg of duloxetine (as hydrochloride)

3. LIST OF EXCIPIENTS

Contains sucrose

See leaflet for further information

4. PHARMACEUTICAL FORM AND CONTENTS

Multipack comprising 2 packs, each containing 98 capsules

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

Store in the original package in order to protect from moisture. Do not store above 30°C

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

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/04/280/006

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

YENTREVE 40 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 (40 mg hard gastro- resistant capsules)

1. NAME OF THE MEDICINAL PRODUCT

YENTREVE 40 mg hard gastro-resistant capsules

Duloxetine

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Lilly

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTONS FOR 20 MG HARD GASTRO-RESISTANT CAPSULES

1. NAME OF THE MEDICINAL PRODUCT

YENTREVE 20 mg hard gastro-resistant capsules.

Duloxetine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each capsule contains 20 mg of duloxetine (as hydrochloride)

3. LIST OF EXCIPIENTS

Contains sucrose

See leaflet for further information

4. PHARMACEUTICAL FORM AND CONTENTS

56 hard gastro-resistant capsules

28 hard gastro-resistant capsules

98 hard gastro-resistant capsules

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use.

Read the 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

Store in the original package in order to protect from moisture. Do not store above 30°C

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

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/04/280/001 (56 hard gastro-resistant capsules)

EU/1/04/280/007 (28 hard gastro-resistant capsules)

EU/1/04/280/008 (98 hard gastro-resistant capsules)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

YENTREVE 20 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 (20 mg hard gastro- resistant capsules)

1. NAME OF THE MEDICINAL PRODUCT

YENTREVE 20 mg hard gastro-resistant capsules

Duloxetine

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Lilly

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

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