English
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Evista (raloxifene hydrochloride) – Labelling - G03XC01

Updated on site: 06-Oct-2017

Medication nameEvista
ATC CodeG03XC01
Substanceraloxifene hydrochloride
ManufacturerDaiichi Sankyo Europe GmbH

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE

PACKAGING

BOTTLE LABEL, BOTTLE CARTON:

1.NAME OF THE MEDICINAL PRODUCT

EVISTA 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

3.LIST OF EXCIPIENTS

Also includes lactose

See leaflet for further information

4.PHARMACEUTICAL FORM AND CONTENTS

100 film coated tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

For oral use

6.SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

OF THE REACH AND SIGHT OF CHILDREN

Keep out of the reach and sight of children.

7.OTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE

9.SPECIAL STORAGE CONDITIONS

Store in the original package.

Do not freeze.

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:

Daiichi Sankyo Europe GmbH

Zielstattstrasse 48

D-81379 Munich

Germany

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/98/073/004

13.BATCH NUMBER

Batch {number}

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Evista

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BLISTER BOX FILM COATED TABLETS:

1. NAME OF THE MEDICINAL PRODUCT

EVISTA 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

3. LIST OF EXCIPIENTS

Also includes lactose

See leaflet for further information

4. PHARMACEUTICAL FORM AND CONTENTS

14 film coated tablets

28 film coated tablets

84 film coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For oral use

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

OF THE REACH AND SIGHT OF CHILDREN

Keep out of the reach and sight of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

9. SPECIAL STORAGE CONDITIONS

Store in the original package. Do not freeze.

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:

Daiichi Sankyo Europe GmbH

Zielstattstrasse 48

D-81379 Munich

Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/98/073/001 14 film coated tablets

EU/1/98/073/002 28 film coated tablets

EU/1/98/073/003 84 film coated tablets

13. BATCH NUMBER

Batch {number}

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Evista

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER (ALL BLISTER PACKS):

1. NAME OF THE MEDICINAL PRODUCT

EVISTA 60 mg film coated tablets raloxifene hydrochloride

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Daiichi Sankyo Europe GmbH

3.EXPIRY DATE

4.BATCH NUMBER

Lot {number}

5.OTHER

Comments

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
  • Help
  • Get it on Google Play
  • About
  • Info on site by:

  • Presented by RXed.eu

  • 27558

    prescription drugs listed