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Erelzi (etanercept) – Labelling - L04AB01

Updated on site: 06-Oct-2017

Medication nameErelzi
ATC CodeL04AB01
Substanceetanercept
ManufacturerSandoz GmbH

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF UNIT PACK – 25 MG PRE-FILLED SYRINGE

1.NAME OF THE MEDICINAL PRODUCT

Erelzi 25 mg solution for injection in pre-filled syringe etanercept

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each pre-filled syringe contains 25 mg etanercept.

3.LIST OF EXCIPIENTS

The other ingredients are:

Citric acid anhydrous, sodium citrate dihydrate, sodium chloride, sucrose, L-lysine hydrochloride, sodium hydroxide, hydrochloric acid and water for injection.

4.PHARMACEUTICAL FORM AND CONTENTS

1 pre-filled syringe with a needle guard

2 pre-filled syringes with a needle guard

4 pre-filled syringes with a needle guard

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Single use.

Subcutaneous use.

Injection:

Prior to use, allow 15 to 30 minutes for the solution to reach room temperature.

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 a refrigerator.

Do not freeze.

Keep the pre-filled syringe in the outer carton in order to protect from light.

Keep the pre-filled syringes in the outer carton in order to protect from light.

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

Sandoz GmbH

Biochemiestr. 10

A-6250 Kundl

Austria

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/17/1195/001

EU/1/17/1195/002

EU/1/17/1195/003

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

‘QR code to be included’ + <www.erelzi.eu>

16.INFORMATION IN BRAILLE

Erelzi 25 mg

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN:

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX) – 25 MG PRE-FILLED SYRINGE

1. NAME OF THE MEDICINAL PRODUCT

Erelzi 25 mg solution for injection in pre-filled syringe etanercept

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each pre-filled syringe contains 25 mg etanercept.

3. LIST OF EXCIPIENTS

The other ingredients are:

Citric acid anhydrous, sodium citrate dihydrate, sodium chloride, sucrose, L-lysine hydrochloride, sodium hydroxide, hydrochloric acid and water for injection.

4. PHARMACEUTICAL FORM AND CONTENTS

Multipack: 12 (3 packs of 4) pre-filled syringes with a needle guard.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Single use.

Subcutaneous use.

Injection:

Prior to use, allow 15 to 30 minutes for the solution to reach room temperature.

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 a refrigerator.

Do not freeze.

Keep the pre-filled syringes in the outer carton in order to protect from light.

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

Sandoz GmbH

Biochemiestr. 10

A-6250 Kundl

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/17/1195/004

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

‘QR code to be included’ + <www.erelzi.eu>

16. INFORMATION IN BRAILLE

Erelzi 25 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN:

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX) – 25 MG PRE-FILLED SYRINGE

1. NAME OF THE MEDICINAL PRODUCT

Erelzi 25 mg solution for injection in pre-filled syringe etanercept

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each pre-filled syringe contains 25 mg etanercept.

3. LIST OF EXCIPIENTS

The other ingredients are:

Citric acid anhydrous, sodium citrate dihydrate, sodium chloride, sucrose, L-lysine hydrochloride, sodium hydroxide, hydrochloric acid and water for injection.

4. PHARMACEUTICAL FORM AND CONTENTS

4 pre-filled syringes with a needle guard. Component of a multipack. Not to be sold separately.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Single use.

Subcutaneous use.

Injection:

Prior to use, allow 15 to 30 minutes for the solution to reach room temperature.

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 a refrigerator.

Do not freeze.

Keep the pre-filled syringes in the outer carton in order to protect from light.

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

Sandoz GmbH

Biochemiestr. 10

A-6250 Kundl

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/17/1195/004

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

‘QR code to be included’ + <www.erelzi.eu>

16. INFORMATION IN BRAILLE

Erelzi 25 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 TEXT FOR TRAY BACK – 25 MG PRE-FILLED SYRINGE

1. NAME OF THE MEDICINAL PRODUCT

Erelzi 25 mg Injection etanercept

2.NAME OF THE MARKETING AUTHORISATION HOLDER

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

SC

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

TEXT FOR PRE-FILLED SYRINGE LABEL – 25 MG PRE-FILLED SYRINGE

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Erelzi 25 mg injection etanercept SC

2.METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF UNIT PACK – 50 MG PRE-FILLED SYRINGE

1. NAME OF THE MEDICINAL PRODUCT

Erelzi 50 mg solution for injection in pre-filled syringe etanercept

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each pre-filled syringe contains 50 mg etanercept.

3. LIST OF EXCIPIENTS

The other ingredients are:

Citric acid anhydrous, sodium citrate dihydrate, sodium chloride, sucrose, L-lysine hydrochloride, sodium hydroxide, hydrochloric acid and water for injection.

4. PHARMACEUTICAL FORM AND CONTENTS

1 pre-filled syringe with a needle guard

2 pre-filled syringes with a needle guard

4 pre-filled syringes with a needle guard

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Single use.

Subcutaneous use.

Injection:

Prior to use, allow 15 to 30 minutes for the solution to reach room temperature.

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 a refrigerator.

Do not freeze.

Keep the pre-filled syringe in the outer carton in order to protect from light.

Keep the pre-filled syringes in the outer carton in order to protect from light.

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

Sandoz GmbH

Biochemiestr. 10

A-6250 Kundl

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/17/1195/005

EU/1/17/1195/006

EU/1/17/1195/007

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

‘QR code to be included’ + <www.erelzi.eu>

16. INFORMATION IN BRAILLE

Erelzi 50 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN:

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX) – 50 MG PRE-FILLED SYRINGE

1. NAME OF THE MEDICINAL PRODUCT

Erelzi 50 mg solution for injection in pre-filled syringe etanercept

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each pre-filled syringe contains 50 mg etanercept.

3. LIST OF EXCIPIENTS

The other ingredients are:

Citric acid anhydrous, sodium citrate dihydrate, sodium chloride, sucrose, L-lysine hydrochloride, sodium hydroxide, hydrochloric acid and water for injection.

4. PHARMACEUTICAL FORM AND CONTENTS

Multipack: 12 (3 packs of 4) pre-filled syringes with a needle guard.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Single use.

Subcutaneous use.

Injection:

Prior to use, allow 15 to 30 minutes for the solution to reach room temperature.

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 a refrigerator.

Do not freeze.

Keep the pre-filled syringes in the outer carton in order to protect from light.

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

Sandoz GmbH

Biochemiestr. 10

A-6250 Kundl

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/17/1195/008

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

‘QR code to be included’ + <www.erelzi.eu>

16. INFORMATION IN BRAILLE

Erelzi 50 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN:

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX) – 50 MG PRE-FILLED SYRINGE

1. NAME OF THE MEDICINAL PRODUCT

Erelzi 50 mg solution for injection in pre-filled syringe etanercept

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each pre-filled syringe contains 50 mg etanercept.

3. LIST OF EXCIPIENTS

The other ingredients are:

Citric acid anhydrous, sodium citrate dihydrate, sodium chloride, sucrose, L-lysine hydrochloride, sodium hydroxide, hydrochloric acid and water for injection.

4. PHARMACEUTICAL FORM AND CONTENTS

4 pre-filled syringes with a needle guard. Component of a multipack. Not to be sold separately.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Single use.

Subcutaneous use.

Injection:

Prior to use, allow 15 to 30 minutes for the solution to reach room temperature.

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 a refrigerator.

Do not freeze.

Keep the pre-filled syringes in the outer carton in order to protect from light.

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

Sandoz GmbH

Biochemiestr. 10

A-6250 Kundl

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/17/1195/008

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

‘QR code to be included’ + <www.erelzi.eu>

16. INFORMATION IN BRAILLE

Erelzi 50 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 TEXT FOR TRAY BACK – 50 MG PRE-FILLED SYRINGE

1. NAME OF THE MEDICINAL PRODUCT

Erelzi 50 mg Injection etanercept

2. NAME OF THE MARKETING AUTHORISATION HOLDER

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

SC

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

TEXT FOR PRE-FILLED SYRINGE LABEL – 50 MG PRE-FILLED SYRINGE

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Erelzi 50 mg injection etanercept SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF UNIT PACK – 50 MG PRE-FILLED PEN

1. NAME OF THE MEDICINAL PRODUCT

Erelzi 50 mg solution for injection in pre-filled pen etanercept

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each pre-filled pen contains 50 mg etanercept.

3. LIST OF EXCIPIENTS

The other ingredients are:

Citric acid anhydrous, sodium citrate dihydrate, sodium chloride, sucrose, L-lysine hydrochloride, sodium hydroxide, hydrochloric acid and water for injection.

4. PHARMACEUTICAL FORM AND CONTENTS

1pre-filled SensoReady pen

2pre-filled SensoReady pens

4pre-filled SensoReady pens

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Single use.

Subcutaneous use.

Injection:

Prior to use, allow 15 to 30 minutes for the solution to reach room temperature.

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 a refrigerator.

Do not freeze.

Keep the pre-filled SensoReady pen in the outer carton in order to protect from light. Keep the pre-filled SensoReady pens in the outer carton in order to protect from light.

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

Sandoz GmbH

Biochemiestr. 10

A-6250 Kundl

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/17/1195/009

EU/1/17/1195/010

EU/1/17/1195/011

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

‘QR code to be included’ + <www.erelzi.eu>

16. INFORMATION IN BRAILLE

Erelzi 50 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN:

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX) – 50 MG PRE-FILLED PEN

1. NAME OF THE MEDICINAL PRODUCT

Erelzi 50 mg solution for injection in pre-filled pen etanercept

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each pre-filled pen contains 50 mg etanercept.

3. LIST OF EXCIPIENTS

The other ingredients are:

Citric acid anhydrous, sodium citrate dihydrate, sodium chloride, sucrose, L-lysine hydrochloride, sodium hydroxide, hydrochloric acid and water for injection.

4. PHARMACEUTICAL FORM AND CONTENTS

Multipack: 12 (3 packs of 4) pre-filled SensoReady pens.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Single use.

Subcutaneous use.

Injection:

Prior to use, allow 15 to 30 minutes for the solution to reach room temperature.

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 a refrigerator.

Do not freeze.

Keep the pre-filled SensoReady pens in the outer carton in order to protect from light.

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

Sandoz GmbH

Biochemiestr. 10

A-6250 Kundl

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/17/1195/012

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

‘QR code to be included’ + <www.erelzi.eu>

16. INFORMATION IN BRAILLE

Erelzi 50 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN:

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX) – 50 MG PRE-FILLED PEN

1. NAME OF THE MEDICINAL PRODUCT

Erelzi 50 mg solution for injection in pre-filled pen etanercept

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each pre-filled pen contains 50 mg etanercept.

3. LIST OF EXCIPIENTS

The other ingredients are:

Citric acid anhydrous, sodium citrate dihydrate, sodium chloride, sucrose, L-lysine hydrochloride, sodium hydroxide, hydrochloric acid and water for injection.

4. PHARMACEUTICAL FORM AND CONTENTS

4 pre-filled SensoReady pens. Component of a multipack. Not to be sold separately.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Single use.

Subcutaneous use.

Injection:

Prior to use, allow 15 to 30 minutes for the solution to reach room temperature.

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 a refrigerator.

Do not freeze.

Keep the pre-filled SensoReady pens in the outer carton in order to protect from light.

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

Sandoz GmbH

Biochemiestr. 10

A-6250 Kundl

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/17/1195/012

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

‘QR code to be included’ + <www.erelzi.eu>

16. INFORMATION IN BRAILLE

Erelzi 50 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 SMALL IMMEDIATE PACKAGING UNITS

TEXT FOR PRE-FILLED PEN LABEL – 50 MG PRE-FILLED PEN

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Erelzi 50 mg Injection etanercept SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6. OTHER

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