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Ucedane (carglumic acid) – Labelling - A16AA05

Updated on site: 10-Oct-2017

Medication nameUcedane
ATC CodeA16AA05
Substancecarglumic acid
ManufacturerLucane Pharma

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

Ucedane 200 mg dispersible tablets carglumic acid

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 200 mg of carglumic acid.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

60 dispersible tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use only.

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

Lucane Pharma

172 rue de Charonne

75011 Paris France

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/17/1202/001

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Ucedane 200 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

Ucedane 200 mg dispersible tablets carglumic acid

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Lucane Pharma

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Batch

5.OTHER

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