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Valdoxan (agomelatine) – Labelling - N06AX22

Updated on site: 10-Oct-2017

Medication nameValdoxan
ATC CodeN06AX22
Substanceagomelatine
ManufacturerLes Laboratoires Servier

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer carton

1.NAME OF THE MEDICINAL PRODUCT

Valdoxan 25 mg film-coated tablets

Agomelatine

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 25 mg of agomelatine.

3.LIST OF EXCIPIENTS

Contains lactose.

See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

7 film-coated tablets

14 film-coated tablets

28 film-coated tablets

42 film-coated tablets

56 film-coated tablets

84 film-coated tablets

98 film-coated tablets

100 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

Les Laboratoires Servier 50, rue Carnot

92284 Suresnes cedex France

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/08/499/001 7 film-coated tablets [EU/1/08/499/002] 14 film-coated tablets [EU/1/08/499/003] 28 film-coated tablets [EU/1/08/499/004] 42 film-coated tablets [EU/1/08/499/005] 56 film-coated tablets [EU/1/08/499/006] 84 film-coated tablets [EU/1/08/499/007] 98 film-coated tablets [EU/1/08/499/008] 100 film-coated tablets

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Valdoxan 25 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

Valdoxan 25 mg tablets

Agomelatine

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Les Laboratoires Servier

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

MON

TUE

WED

THU

FRI

SAT

SUN

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