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Xtandi (enzalutamide) – Labelling - L02BB04

Updated on site: 11-Oct-2017

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON WITH BLUE BOX

1.NAME OF THE MEDICINAL PRODUCT

Xtandi 40 mg soft capsules enzalutamide

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each capsule contains 40 mg enzalutamide.

3.LIST OF EXCIPIENTS

Contains sorbitol (E420).

See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

112 soft capsules

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

Astellas Pharma Europe B.V.

Sylviusweg 62

2333 BE Leiden

The Netherlands

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/13/846/001 112 soft capsules

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

xtandi 40 mg

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

WALLET WITHOUT BLUE BOX

1. NAME OF THE MEDICINAL PRODUCT

Xtandi 40 mg soft capsules enzalutamide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each capsule contains 40 mg enzalutamide.

3. LIST OF EXCIPIENTS

Contains sorbitol (E420).

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

28 soft capsules

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use.

Monday

Tuesday

Wednesday

Thursday

Friday

Saturday

Sunday

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

Astellas Pharma Europe B.V.

Sylviusweg 62

2333 BE Leiden

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

xtandi 40 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Xtandi 40 mg

2.NAME OF THE MARKETING AUTHORISATION HOLDER

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

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