English
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Emtriva (emtricitabine) – Labelling - J05AF09

Updated on site: 06-Oct-2017

Medication nameEmtriva
ATC CodeJ05AF09
Substanceemtricitabine
ManufacturerGilead Sciences International Limited

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

BOTTLE AND CARTON LABELLING

1.NAME OF THE MEDICINAL PRODUCT

Emtriva 200 mg hard capsules

Emtricitabine

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each hard capsule contains 200 mg of emtricitabine.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

30 hard capsules.

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use.

Read the package leaflet before 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 Intl Ltd.

Cambridge

CB21 6GT

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/03/261/001

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Emtriva [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}

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

BLISTER CARTON LABELLING

1.NAME OF THE MEDICINAL PRODUCT

Emtriva 200 mg hard capsules

Emtricitabine

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each hard capsule contains 200 mg of emtricitabine.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

30 hard capsules.

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use.

Read the package leaflet before 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 Intl Ltd.

Cambridge

CB21 6GT

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/03/261/002

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Emtriva [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}

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER

1.NAME OF THE MEDICINAL PRODUCT

Emtriva 200 mg hard capsules

Emtricitabine

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Gilead Sciences Intl Ltd.

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

BOTTLE AND CARTON LABELLING

1.NAME OF THE MEDICINAL PRODUCT

Emtriva 10 mg/ml oral solution

Emtricitabine

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each ml contains 10 mg of emtricitabine.

3.LIST OF EXCIPIENTS

Contains E110, E216, E218, and sodium, see leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

170 ml oral solution.

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use.

Read the package leaflet before 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

After opening: the solution should be used within 45 days. It is advised to write the date of removal from the refrigerator on the package.

Opened:

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

After opening: do not store above 25ºC.

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/1/03/261/003

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Emtriva [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}

Comments

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
  • Help
  • Get it on Google Play
  • About
  • Info on site by:

  • Presented by RXed.eu

  • 27558

    prescription drugs listed