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Raloxifene Teva (raloxifene hydrochloride) – Labelling - G03XC01

Updated on site: 09-Oct-2017

Medication nameRaloxifene Teva
ATC CodeG03XC01
Substanceraloxifene hydrochloride
ManufacturerTeva B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1.NAME OF THE MEDICINAL PRODUCT

Raloxifene Teva 60 mg film-coated tablets raloxifene hydrochloride

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 60 mg raloxifene hydrochloride, equivalent to 56 mg raloxifene free base.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablet

14 film-coated tablets

28 film-coated tablets

84 film-coated tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Swallow tablets whole.

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

Do not store above 25°C. Store in the original package 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

Teva B.V.

Swensweg 5

2031GA Haarlem

The Netherlands

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/10/627/001 14 film coated tablets

EU/1/10/627/002 28 film coated tablets

EU/1/10/627/003 84 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

Raloxifene Teva 60 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

1. NAME OF THE MEDICINAL PRODUCT

Raloxifene Teva 60 mg film-coated tablets raloxifene hydrochloride

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Teva B.V.

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

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