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Xenical (orlistat) – Labelling - A08AB01

Updated on site: 11-Oct-2017

Medication nameXenical
ATC CodeA08AB01
Substanceorlistat
ManufacturerCHEPLAPHARM Arzneimittel GmbH

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON FOR BLISTER PACKS

1.NAME OF THE MEDICINAL PRODUCT

Xenical 120 mg hard capsules

Orlistat

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each capsule contains 120 mg orlistat.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

21 hard capsules

42 hard capsules

84 hard 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

Do not store above 25 °C

Store in original package and keep the blister in the outer carton in order to protect from light and moisture.

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

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/98/071/001 21 capsules

EU/1/98/071/002 42 capsules

EU/1/98/071/003 84 capsules

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

xenical

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

BLISTER FOIL

1. NAME OF THE MEDICINAL PRODUCT

Xenical 120 mg hard capsules

Orlistat

2.NAME OF THE MARKETING AUTHORISATION HOLDER

CHEPLAPHARM Arzneimittel GmbH

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE

PACKAGING

OUTER CARTON AND BOTTLE LABEL

1. NAME OF THE MEDICINAL PRODUCT

Xenical 120 mg hard capsules

Orlistat

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each capsule contains 120 mg orlistat.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

21 hard capsules

42 hard capsules

84 hard 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

Do not store above 30 °C

Keep the container tightly closed in order to protect from moisture

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

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/98/071/004 21 capsules

EU/1/98/071/005 42 capsules

EU/1/98/071/006 84 capsules

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

xenical

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

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