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Odefsey (emtricitabine / rilpivirine hydrochloride...) – Labelling - J05AR19

Updated on site: 08-Oct-2017

Medication nameOdefsey
ATC CodeJ05AR19
Substanceemtricitabine / rilpivirine hydrochloride / tenofovir alafenamide
ManufacturerGilead Sciences International Ltd 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

BOTTLE AND CARTON LABELLING

1.NAME OF THE MEDICINAL PRODUCT

Odefsey 200 mg/25 mg/25 mg film-coated tablets emtricitabine/rilpivirine/tenofovir alafenamide

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 200 mg of emtricitabine, rilpivirine hydrochloride equivalent to

25 mg of rilpivirine and tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide.

3.LIST OF EXCIPIENTS

Contains lactose (as monohydrate), see leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

30 film-coated tablets

90 (3 bottles of 30) 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

Store in the original package in order to protect from moisture. Keep the bottle tightly closed.

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

Gilead Sciences Intl Ltd.

Cambridge

CB21 6GT

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/16/1112/001 30 film-coated tablets

EU/1/16/1112/002 90 (3 bottles of 30) film-coated tablets

13.BATCH NUMBER, <DONATION AND PRODUCT CODES>

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Odefsey [Outer packaging only]

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC: {number}

SN: {number}

NN: {number}

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