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Fablyn (lasofoxifene tartrate) – Labelling - G03

Updated on site: 06-Oct-2017

Medication nameFablyn
ATC CodeG03
Substancelasofoxifene tartrate
ManufacturerDr. Friedrich Eberth Arzneimittel GmbH

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR BLISTER PACK (30 film-coated tablets)

1. NAME OF THE MEDICINAL PRODUCT

FABLYN 500 microgram film-coated tablets

lasofoxifene

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains lasofoxifene tartrate, equivalent to 500 microgram lasofoxifene.

 

3.

LIST OF EXCIPIENTS

 

 

 

See the package leaflet for further information.

 

authorised

 

Contains lactose

 

 

 

 

4.

 

 

longer

 

 

PHARMACEUTICAL FORM AND CONTENTS

 

 

30 film-coated tablets

 

 

 

 

 

 

 

no

 

 

 

 

 

 

5.

 

product

 

 

METHOD AND ROUTE(S) OF ADMINISTRATION

 

 

For oral use.

 

 

 

 

Read the package leaflet before use.

 

 

 

 

 

 

 

 

Medicinal

 

 

 

 

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

 

 

Sealed pack.

 

 

 

Do not use if box has been opened.

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

Dr. Friedrich Eberth Arzneimittel GmbH

Am Bahnhof 2

92289 Ursensollen

Germany

12. MARKETING AUTHORISATION NUMBER

EU/1/08/500/001

EU/1/08/500/002

longer

 

EU/1/08/500/003

 

EU/1/08/500/004

 

13.

BATCH NUMBER

no

 

Lot:

 

product

 

 

 

 

14.

GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

Medicinal

 

 

15.

INSTRUCTIONS ON USE

 

16.

INFORMATION IN BRAILLE

 

FABLYN

authorised

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR BLISTER PACK (7 film-coated tablets)

1. NAME OF THE MEDICINAL PRODUCT

FABLYN 500 microgram film-coated tablets

lasofoxifene

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains lasofoxifene tartrate, equivalent to 500 microgram lasofoxifene.

 

3.

LIST OF EXCIPIENTS

 

 

 

See the package leaflet for further information.

 

authorised

 

Contains lactose

 

 

 

 

4.

 

 

longer

 

 

PHARMACEUTICAL FORM AND CONTENTS

 

 

7 film-coated tablets

 

 

 

 

 

 

 

no

 

 

 

 

 

 

5.

 

product

 

 

METHOD AND ROUTE(S) OF ADMINISTRATION

 

 

For oral use.

 

 

 

 

Read the package leaflet before use.

 

 

 

 

 

 

 

 

Medicinal

 

 

 

 

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

 

 

Sealed pack.

 

 

 

Do not use if box has been opened.

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

Dr. Friedrich Eberth Arzneimittel GmbH

Am Bahnhof 2

92289 Ursensollen

Germany

12. MARKETING AUTHORISATION NUMBER

EU/1/08/500/001

EU/1/08/500/002

longer

 

EU/1/08/500/003

 

EU/1/08/500/004

 

13.

BATCH NUMBER

no

 

Lot:

 

product

 

 

 

 

14.

GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

Medicinal

 

 

15.

INSTRUCTIONS ON USE

 

16.

INFORMATION IN BRAILLE

 

FABLYN

authorised

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR BOTTLE PACK (90 film-coated tablets)

1. NAME OF THE MEDICINAL PRODUCT

FABLYN 500 microgram film-coated tablets

lasofoxifene

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains lasofoxifene tartrate, equivalent to 500 microgram lasofoxifene.

 

3.

LIST OF EXCIPIENTS

 

 

 

See the package leaflet for further information.

 

authorised

 

Contains lactose

 

 

 

 

4.

 

 

longer

 

 

PHARMACEUTICAL FORM AND CONTENTS

 

 

90 film-coated tablets

 

 

 

 

 

 

 

no

 

 

 

 

 

 

5.

 

product

 

 

METHOD AND ROUTE(S) OF ADMINISTRATION

 

 

For oral use.

 

 

 

 

Read the package leaflet before use.

 

 

 

 

 

 

 

 

Medicinal

 

 

 

 

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

 

 

Sealed pack.

 

 

 

Do not use if box has been opened.

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

Dr. Friedrich Eberth Arzneimittel GmbH

Am Bahnhof 2

92289 Ursensollen

Germany

12. MARKETING AUTHORISATION NUMBER

EU/1/08/500/001

EU/1/08/500/002

longer

 

EU/1/08/500/003

 

EU/1/08/500/004

 

13.

BATCH NUMBER

no

 

Lot:

 

product

 

 

 

 

14.

GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

Medicinal

 

 

15.

INSTRUCTIONS ON USE

 

16.

INFORMATION IN BRAILLE

 

FABLYN

authorised

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR BLISTER PACK (28 film-coated tablets)

1. NAME OF THE MEDICINAL PRODUCT

FABLYN 500 microgram film-coated tablets

lasofoxifene

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains lasofoxifene tartrate, equivalent to 500 microgram lasofoxifene.

 

3.

LIST OF EXCIPIENTS

 

 

 

See the package leaflet for further information.

 

authorised

 

Contains lactose

 

 

 

 

4.

 

 

longer

 

 

PHARMACEUTICAL FORM AND CONTENTS

 

 

28 film-coated tablets

 

 

 

 

 

 

 

no

 

 

 

 

 

 

5.

 

product

 

 

METHOD AND ROUTE(S) OF ADMINISTRATION

 

 

For oral use.

 

 

 

 

Read the package leaflet before use.

 

 

 

 

 

 

 

 

Medicinal

 

 

 

 

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

 

 

Sealed pack.

 

 

 

Do not use if box has been opened.

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

Dr. Friedrich Eberth Arzneimittel GmbH

Am Bahnhof 2

92289 Ursensollen

Germany

12. MARKETING AUTHORISATION NUMBER

EU/1/08/500/001

EU/1/08/500/002

longer

 

EU/1/08/500/003

 

EU/1/08/500/004

 

13.

BATCH NUMBER

no

 

Lot:

 

product

 

 

 

 

14.

GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

Medicinal

 

 

15.

INSTRUCTIONS ON USE

 

16.

INFORMATION IN BRAILLE

 

FABLYN

authorised

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

BOTTLE LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

FABLYN 500 microgram film-coated tablets

 

 

 

lasofoxifene

 

 

authorised

For oral use

 

 

 

 

 

 

 

 

 

 

2.

METHOD OF ADMINISTRATION

 

 

 

Read the package leaflet before use.

 

 

 

 

 

 

 

 

3.

EXPIRY DATE

 

 

 

LOT:

 

 

longer

 

EXP:

 

 

 

 

4.

BATCH NUMBER

 

 

 

 

 

no

 

 

5.

product

 

 

 

CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

 

90 film-coated tablets

6.OTHER

Medicinal

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER 7 tablets

1. NAME OF THE MEDICINAL PRODUCT

FABLYN 500 microgram film-coated tablets

lasofoxifene

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Eberth

authorised

3.EXPIRY DATE

EXP:

 

 

 

 

 

4.

BATCH NUMBER

 

longer

 

 

LOT:

 

 

 

 

 

 

 

 

 

5.

OTHER

 

no

 

 

 

 

Mon

 

product

 

 

 

 

 

 

Tue

 

 

 

 

Wed

 

 

 

 

Thu

 

 

 

 

Medicinal

 

 

 

Fri

 

 

 

 

Sat

Sun

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER 30 tablets

1. NAME OF THE MEDICINAL PRODUCT

FABLYN 500 microgram film-coated tablets

lasofoxifene

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Eberth

authorised

3.EXPIRY DATE

EXP:

 

 

 

 

 

4.

BATCH NUMBER

 

longer

 

 

LOT:

 

 

 

 

 

 

 

 

 

5.

OTHER

 

no

 

 

 

 

Medicinal

product

 

 

 

 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER 28 tablets

1. NAME OF THE MEDICINAL PRODUCT

FABLYN 500 microgram film-coated tablets

lasofoxifene

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Eberth

authorised

3.EXPIRY DATE

EXP:

 

 

 

 

 

4.

BATCH NUMBER

 

longer

 

 

LOT:

 

 

 

 

 

 

 

 

 

5.

OTHER

 

no

 

 

 

 

Mon

 

product

 

 

 

 

 

 

Tue

 

 

 

 

Wed

 

 

 

 

Thu

 

 

 

 

Medicinal

 

 

 

Fri

 

 

 

 

Sat

Sun

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