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Ibandronic Acid Teva (ibandronic acid) – Labelling - M05BA06

Updated on site: 07-Oct-2017

Medication nameIbandronic Acid Teva
ATC CodeM05BA06
Substanceibandronic acid
ManufacturerTeva Pharma B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

Ibandronic Acid Teva 50 mg film-coated tablets ibandronic acid

2.STATEMENT OF ACTIVE SUBSTANCE

Each film-coated tablet contains 50 mg ibandronic acid (as sodium monohydrate).

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablet

28 film-coated tablets

84 film-coated tablets

5.METHOD AND ROUTE OF ADMINISTRATION

Do not suck, chew or crush the tablets.

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

Teva B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/10/642/001

28 film-coated tablets

EU/1/10/642/002

 

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

Ibandronic Acid Teva 50 mg film-coated tablets

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Ibandronic Acid Teva 50 mg film-coated tablets ibandronic acid

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Teva B.V.

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

Mon.

Tue.

Wed.

Thu.

Fri.

Sat.

Sun.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Ibandronic Acid Teva 150 mg film-coated tablets ibandronic acid

2. STATEMENT OF ACTIVE SUBSTANCE

Each film-coated tablet contains 150 mg ibandronic acid (as sodium monohydrate).

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablet

1 film-coated tablet

3 film-coated tablets

5. METHOD AND ROUTE OF ADMINISTRATION

Do not suck, chew or crush the tablet.

Once monthly tablet.

Note down the date you take your tablet.

Month 1 __/__/__

Month 2 __/__/__

Month 3 __/__/__

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

Teva B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/10/642/003

1 film-coated tablet

 

EU/1/10/642/004

 

3 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

Ibandronic Acid Teva 150 mg film-coated tablets

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Ibandronic Acid Teva 150 mg film-coated tablets ibandronic acid

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Teva B.V.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

3 film-coated tablets pack

Month 1

Month 2

Month 3

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