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Evotaz (atazanavir sulfate / cobicistat) – Labelling - J05AR

Updated on site: 06-Oct-2017

Medication nameEvotaz
ATC CodeJ05AR
Substanceatazanavir sulfate / cobicistat
ManufacturerBristol-Myers Squibb Pharma EEIG

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON TEXT AND BOTTLE LABEL

1.NAME OF THE MEDICINAL PRODUCT

EVOTAZ 300 mg/150 mg film-coated tablets atazanavir/cobicistat

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 300 mg of atazanavir (as sulphate) and 150 mg of cobicistat.

3.LIST OF EXCIPIENTS

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

Do not store above 30°C.

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

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1025/001 30 film-coated tablets

EU/1/15/1025/002 90 (3 bottles of 30) 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

evotaz

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

<NN>:

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