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Harvoni (ledispavir 90 mg / sofosbuvir 400 mg) – Labelling - J05AX65

Updated on site: 07-Oct-2017

Medication nameHarvoni
ATC CodeJ05AX65
Substanceledispavir 90 mg / sofosbuvir 400 mg
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

Harvoni 90 mg/400 mg film-coated tablets ledipasvir/sofosbuvir

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 90 mg ledipasvir and 400 mg sofosbuvir.

3.LIST OF EXCIPIENTS

Contains lactose and sunset yellow FCF aluminium lake (E110). See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

28 film-coated tablets.

84 (3 bottles of 28) 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

Gilead Sciences International Ltd

Cambridge

CB21 6GT

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/14/958/001 28 film-coated tablets

EU/1/14/958/002 84 (3 bottles of 28) 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

Harvoni [Outer packaging only]

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