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Ibandronic Acid Sandoz (ibandronic acid) – Labelling - M05BA06

Updated on site: 07-Oct-2017

Medication nameIbandronic Acid Sandoz
ATC CodeM05BA06
Substanceibandronic acid
ManufacturerSandoz GmbH

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer Carton

1.NAME OF THE MEDICINAL PRODUCT

Ibandronic acid Sandoz 50 mg film-coated tablets ibandronic acid

2.STATEMENT OF ACTIVE SUBSTANCE(S)

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

3.LIST OF EXCIPIENTS

The tablets also contain lactose.

See package leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

3 film-coated tablets

6 film-coated tablets

9 film-coated tablets

28 film-coated tablets

84 film-coated tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Do not suck, chew or crush 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

Store in the original package in order 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

Sandoz GmbH

Biochemiestraße 10

A-6250 Kundl

Austria

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/11/685/001

EU/1/11/685/002

EU/1/11/685/003

EU/1/11/685/004

EU/1/11/685/005

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Ibandronic acid Sandoz 50 mg

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC: {number}

SN: {number}

NN: {number}

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Polyamide/Al/PVC - Aluminium foil blister

1. NAME OF THE MEDICINAL PRODUCT

Ibandronic acid Sandoz 50 mg film-coated tablets ibandronic acid

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Sandoz GmbH

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

Mon

Tue

Wed

Thu

Fri

Sat

Sun

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