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Ivabradine Accord (ivabradine hydrochloride) – Labelling - C01EB17

Updated on site: 08-Oct-2017

Medication nameIvabradine Accord
ATC CodeC01EB17
Substanceivabradine hydrochloride
ManufacturerAccord Healthcare Ltd

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

Ivabradine Accord 5 mg film-coated tablets Ivabradine Accord 7.5 mg film-coated tablets ivabradine

2.STATEMENT OF ACTIVE SUBSTANCE(S)

One film-coated tablet contains 5 mg ivabradine (as hydrochloride)

One film-coated tablet contains 7.5 mg ivabradine (as hydrochloride)

3.LIST OF EXCIPIENTS

Also contains lactose.

See package leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablet

14x1 film-coated tablets

28x1 film-coated tablets

56x1 film-coated tablets

84x1 film-coated tablets

98x1 film-coated tablets

100x1 film-coated tablets

112x1 film-coated tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

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

Accord Healthcare Limited

Sage House, 319 Pinner Road

North Harrow, Middlesex, HA1 4HF

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

Ivabradine Accord 5 mg film-coated tablets

EU/1/17/1190/001

14x1 film-coated tablets

EU/1/17/1190/002

28x1 film-coated tablets

 

EU/1/17/1190/003

56x1 film-coated tablets

 

EU/1/17/1190/004

84x1 film-coated tablets

 

EU/1/17/1190/005

98x1 film-coated tablets

 

EU/1/17/1190/006

100x1 film-coated tablets

 

EU/1/17/1190/007

112x1 film-coated tablets

Ivabradine Accord 7.5 mg film-coated tablets

EU/1/17/1190/008

14x1 film-coated tablets

EU/1/17/1190/009

28x1 film-coated tablets

 

EU/1/17/1190/010

56x1 film-coated tablets

 

EU/1/17/1190/011

84x1 film-coated tablets

 

EU/1/17/1190/012

98x1 film-coated tablets

 

EU/1/17/1190/013

100x1 film-coated tablets

 

EU/1/17/1190/014

112x1 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

Ivabradine Accord 5 mg

Ivabradine Accord 7.5 mg

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

Ivabradine Accord 5 mg film-coated tablets Ivabradine Accord 7.5 mg film-coated tablets ivabradine

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Accord

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

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