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Matever (levetiracetam) – Labelling - N03AX14

Updated on site: 08-Oct-2017

Medication nameMatever
ATC CodeN03AX14
Substancelevetiracetam
ManufacturerPharmathen S.A.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Box of 20, 30, 50, 60, 100

multipack containing 200 (2 x 100) [with Blue Box]

1.NAME OF THE MEDICINAL PRODUCT

Matever 250 mg film-coated tablets

Levetiracetam

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 250 mg levetiracetam.

3.LIST OF EXCIPIENTS

Contains sunset yellow FCF aluminium lake (E110) and propylene glycol (E1520). See the package leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

20 film-coated tablets

30 film-coated tablets

50 film-coated tablets

60 film-coated tablets

100 film-coated tablets

Multipack: 200 (2 packs of 100) film-coated tablets

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 WASTEMATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Pharmathen S.A. 6, Dervenakion str.

Pallini 15351, Attiki, Greece Tel.: +30 210 66 04 300 Email: info@pharmathen.com

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/11/711/001

EU/1/11/711/002

EU/1/11/711/003

EU/1/11/711/004

EU/1/11/711/005

EU/1/11/711/006

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Matever 250 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 packaging containing 100 tablets for multipack of 200 (2 x 100) tablets [without Blue Box]

1. NAME OF THE MEDICINAL PRODUCT

Matever 250 mg film-coated tablets

Levetiracetam

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 250 mg levetiracetam.

3. LIST OF EXCIPIENTS

Contains sunset yellow FCF aluminium lake (E110) and propylene glycol (E1520). See the package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

100 film-coated tablets.

Component of a multipack, can’t be sold separately.

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

Pharmathen S.A. 6, Dervenakion str.

Pallini 15351, Attiki, Greece Tel.: +30 210 66 04 300 Email: info@pharmathen.com

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/711/006

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Matever 250 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Aluminium/ PVC/PE/PVDC blister

1. NAME OF THE MEDICINAL PRODUCT

Matever 250 mg film-coated tablets

Levetiracetam

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Pharmathen S.A.

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Box of 10, 20, 30, 50, 60, 100, 120

multipack containing 200 (2 x 100) [with Blue Box]

1. NAME OF THE MEDICINAL PRODUCT

Matever 500 mg film-coated tablets

Levetiracetam

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 500 mg levetiracetam.

3. LIST OF EXCIPIENTS

Contains propylene glycol (E1520). See the package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

10 film-coated tablets

20 film-coated tablets

30 film-coated tablets

50 film-coated tablets

60 film-coated tablets

100 film-coated tablets

120 film-coated tablets

Multipack: 200 (2 packs of 100) film-coated tablets

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

Pharmathen S.A. 6, Dervenakion str.

Pallini 15351, Attiki, Greece Tel.: +30 210 66 04 300 Email: info@pharmathen.com

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/711/007

EU/1/11/711/008

EU/1/11/711/009

EU/1/11/711/010

EU/1/11/711/011

EU/1/11/711/012

EU/1/11/711/013

EU/1/11/711/014

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Matever 500 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 packaging containing 100 tablets for multipack of 200 (2 x 100) tablets [without Blue Box]

1. NAME OF THE MEDICINAL PRODUCT

Matever 500 mg film-coated tablets

Levetiracetam

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 500 mg levetiracetam.

3. LIST OF EXCIPIENTS

Contains propylene glycol (E1520). See the package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

100 film-coated tablets.

Component of a multipack, can’t be sold separately.

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

Pharmathen S.A. 6, Dervenakion str.

Pallini 15351, Attiki, Greece Tel.: +30 210 66 04 300 Email: info@pharmathen.com

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/711/014

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Matever 500 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

MINIMUM PARTICULARS TOAPPEAR ON BLISTERS OR STRIPS Aluminium/ PVC/PE/PVDC blisters

1. NAME OF THE MEDICINAL PRODUCT

Matever 500 mg film-coated tablets

Levetiracetam

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Pharmathen S.A.

3. EXPIRY DATE

EXP

4.BATCHN UMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Box of 20, 30, 50, 60, 80, 100, 120

multipack containing 200 (2 x 100) [with Blue Box]

1. NAME OF THE MEDICINAL PRODUCT

Matever 750 mg film-coated tablets

Levetiracetam

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 750 mg levetiracetam.

3. LIST OF EXCIPIENTS

Contains sunset yellow FCF aluminium lake (E110). See the package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

20 film-coated tablets

30 film-coated tablets

50 film-coated tablets

60 film-coated tablets

80 film-coated tablets

100 film-coated tablets

120 film-coated tablets

Multipack: 200 (2 packs of 100) film-coated tablets

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 SPECIALWARNING(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

Pharmathen S.A. 6, Dervenakion str.

Pallini 15351, Attiki, Greece Tel.: +30 210 66 04 300 Email: info@pharmathen.com

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/711/015

EU/1/11/711/016

EU/1/11/711/017

EU/1/11/711/018

EU/1/11/711/019

EU/1/11/711/020

EU/1/11/711/021

EU/1/11/711/022

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Matever 750 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 packaging containing 100tablets for multipack of 200(2 x 100) tablets [without Blue Box]

1. NAME OF THE MEDICINAL PRODUCT

Matever 750 mg film-coated tablets

Levetiracetam

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 750 mg levetiracetam.

3. LIST OF EXCIPIENTS

Contains sunset yellow FCF aluminium lake (E110). See the package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

100 film-coated tablets.

Component of a multipack, can’t be sold separately.

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 and 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

Pharmathen S.A. 6, Dervenakion str.

Pallini 15351, Attiki, Greece Tel.: +30 210 66 04 300 Email: info@pharmathen.com

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/711/022

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Matever 750 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Aluminium/ PVC/PE/PVDC blister

1. NAME OF THE MEDICINAL PRODUCT

Matever 750 mg film-coated tablets

Levetiracetam

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Pharmathen S.A.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Box of 10, 20, 30, 50, 60, 100

multipack containing 200 (2 x 100) [with Blue Box]

1. NAME OF THE MEDICINAL PRODUCT

Matever 1000 mg film-coated tablets

Levetiracetam

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 1,000 mg levetiracetam.

3. LIST OF EXCIPIENTS

Contains lactose. See the package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

10 film-coated tablets

20 film-coated tablets

30 film-coated tablets

50 film-coated tablets

60 film-coated tablets

100 film-coated tablets

Multipack: 200 (2 packs of 100) film-coated tablets

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

Pharmathen S.A. 6, Dervenakion str.

Pallini 15351, Attiki, Greece Tel.: +30 210 66 04 300 Email: info@pharmathen.com

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/711/023

EU/1/11/711/024

EU/1/11/711/025

EU/1/11/711/026

EU/1/11/711/027

EU/1/11/711/028

EU/1/11/711/029

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Matever 1000 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 packaging containing 100 tablets for multipack of 200(2 x 100) tablets [without Blue Box]

1. NAME OF THE MEDICINAL PRODUCT

Matever 1000 mg film-coated tablets

Levetiracetam

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 1,000 mg levetiracetam.

3. LIST OF EXCIPIENTS

Contains lactose. See the package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

100 film-coated tablets.

Component of a multipack, can’t be sold separately.

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

Pharmathen S.A. 6, Dervenakion str. Pallini Attiki

153 51 Greece

Tel.: +30 210 66 04 300 Email: info@pharmathen.com

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/711/029

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Matever 1000 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Aluminium/ PVC/PE/PVDC blister

1. NAME OF THE MEDICINAL PRODUCT

Matever 1000 mg film-coated tablets

Levetiracetam

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Pharmathen S.A.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Box of 10 vials

1. NAME OF THE MEDICINAL PRODUCT

Matever 100 mg/ml concentrate for solution for infusion

Levetiracetam

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One vial contains 500 mg/5 ml levetiracetam.

Each ml contains 100 mg of levetiracetam.

3. LIST OF EXCIPIENTS

Contains glacial acetic acid, water for injections, sodium acetate trihydrate, sodium chloride - see leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

500 mg/5 ml

10 vials of concentrate for solution for infusion

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intravenous 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

Use immediately after dilution.

9. SPECIAL STORAGE CONDITIONS

No special precautions for storage prior to reconstitution. After dilution the infusion is stable for 24 hours at 2 °C - 8 °C (in a refrigerator)

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

Pharmathen S.A. 6, Dervenakion str.

Pallini 15351, Attiki, Greece Tel.: +30 210 66 04 300 Email: info@pharmathen.com

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/711/030

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Matever 100 mg/ml concentrate for solution for infusion

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

Vial of 5 ml

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

Matever 100 mg/ml concentrate for solution for infusion

Levetiracetam

IV

2.METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

Use immediately after dilution.

4. BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

500 mg/5 ml

6.OTHER

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