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Adenuric (febuxostat) – Labelling - M04AA03

Updated on site: 11-Jul-2017

Medication nameAdenuric
ATC CodeM04AA03
Substancefebuxostat
ManufacturerMenarini International Operations Luxembourg S.A. (MIOL)

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON BOX

1.NAME OF THE MEDICINAL PRODUCT

ADENURIC 80 mg film-coated tablets

Febuxostat

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 80 mg febuxostat.

3.LIST OF EXCIPIENTS

Also contains lactose (as monohydrate).

See the package leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

14 film-coated tablets

28 film-coated tablets

42 film-coated tablets

56 film-coated tablets

84 film-coated tablets

98 film-coated tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

For 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

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

Marketing Authorisation Holder: Menarini International O. L. S.A.

1, Avenue de la Gare, L-1611 Luxembourg Luxembourg

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/08/447/001 28 film-coated tablets

EU/1/08/447/002 84 film-coated tablets

EU/1/08/447/005 14 film-coated tablets

EU/1/08/447/006 42 film-coated tablets

EU/1/08/447/007 56 film-coated tablets

EU/1/08/447/008 98 film-coated tablets

EU/1/08/447/013 14 film-coated tablets

EU/1/08/447/014 28 film-coated tablets

EU/1/08/447/015 42 film-coated tablets

EU/1/08/447/016 56 film-coated tablets

EU/1/08/447/017 84 film-coated tablets

EU/1/08/447/018 98 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

ADENURIC 80 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PVC/ACLAR/ALUMINIUM OR PVC/PE/PVDC/ALUMINIUM BLISTER

1. NAME OF THE MEDICINAL PRODUCT

ADENURIC 80 mg tablets

Febuxostat

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Menarini International O. L. S.A.

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

Mon

Tue

Wed

Thu

Fri

Sat

Sun

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON BOX

1. NAME OF THE MEDICINAL PRODUCT

ADENURIC 120 mg film-coated tablets

Febuxostat

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 120 mg febuxostat.

3. LIST OF EXCIPIENTS

Also contains lactose (as monohydrate).

See the package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

14 film-coated tablets

28 film-coated tablets

42 film-coated tablets

56 film-coated tablets

84 film-coated tablets

98 film-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For 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

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

Marketing Authorisation Holder: Menarini International O. L. S.A.

1, Avenue de la Gare, L-1611 Luxembourg Luxembourg

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/08/447/003 28 film-coated tablets

EU/1/08/447/004 84 film-coated tablets

EU/1/08/447/009 14 film-coated tablets

EU/1/08/447/010 42 film-coated tablets

EU/1/08/447/011 56 film-coated tablets

EU/1/08/447/012 98 film-coated tablets

EU/1/08/447/019 14 film-coated tablets

EU/1/08/447/020 28 film-coated tablets

EU/1/08/447/021 42 film-coated tablets

EU/1/08/447/022 56 film-coated tablets

EU/1/08/447/023 84 film-coated tablets

EU/1/08/447/024 98 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

ADENURIC 120 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PVC/ACLAR/ALUMINIUM OR PVC/PE/PVDC/ALUMINIUM BLISTER

1. NAME OF THE MEDICINAL PRODUCT

ADENURIC 120 mg tablets

Febuxostat

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Menarini International O. L. S.A.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

Mon

Tue

Wed

Thu

Fri

Sat

Sun

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