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Aripiprazole Sandoz (aripiprazole) – Labelling - N05AX12

Updated on site: 05-Oct-2017

Medication nameAripiprazole Sandoz
ATC CodeN05AX12
Substancearipiprazole
ManufacturerSandoz GmbH

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

OUTER CARTON FOR BOTTLE AND LABEL FOR BOTTLE

1.NAME OF THE MEDICINAL PRODUCT

Aripiprazole Sandoz 5 mg tablets aripiprazole

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 5 mg of aripiprazole.

3.LIST OF EXCIPIENTS

Also contains: lactose monohydrate.

See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

Tablet

100 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

Use within 3 months after first opening.

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

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Austria

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1029/014

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Outer carton:Aripiprazole Sandoz 5 mg

17.UNIQUE IDENTIFIER – 2D BARCODE

[Only Carton for bottle:]

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER – HUMAN READABLE DATA

[Only Carton for bottle:] PC: {number}

SN: {number} NN: {number}

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON FOR THE BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

Aripiprazole Sandoz 5 mg tablets aripiprazole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 5 mg of aripiprazole.

3. LIST OF EXCIPIENTS

Also contains: lactose monohydrate.

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Tablet

10 tablets

14 tablets

16 tablets

28 tablets

30 tablets

35 tablets

56 tablets

70 tablets

14 x 1 tablets

28 x 1 tablets

49 x 1 tablets

56 x 1 tablets

98 x 1 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

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1029/001 10 tablets

EU/1/15/1029/002 14 tablets

EU/1/15/1029/003 16 tablets

EU/1/15/1029/004 28 tablets

EU/1/15/1029/005 30 tablets

EU/1/15/1029/006 35 tablets

EU/1/15/1029/007 56 tablets

EU/1/15/1029/008 70 tablets

EU/1/15/1029/009 14 x 1 tablets

EU/1/15/1029/010 28 x 1 tablets

EU/1/15/1029/011 49 x 1 tablets

EU/1/15/1029/012 56 x 1 tablets

EU/1/15/1029/013 98 x 1 tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aripiprazole Sandoz 5 mg

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

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

Aripiprazole Sandoz 5 mg tablets aripiprazole

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Sandoz

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

OUTER CARTON FOR BOTTLE AND LABEL FOR BOTTLE

1. NAME OF THE MEDICINAL PRODUCT

Aripiprazole Sandoz 10 mg tablets aripiprazole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 10 mg of aripiprazole.

3. LIST OF EXCIPIENTS

Also contains: lactose monohydrate.

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Tablet

100 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

Use within 3 months after first opening.

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

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1029/028

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Outer carton: Aripiprazole Sandoz 10 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

[Only Carton for bottle:]

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

[Only Carton for bottle:] PC: {number}

SN: {number} NN: {number}

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON FOR BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Aripiprazole Sandoz 10 mg tablets aripiprazole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 10 mg of aripiprazole.

3. LIST OF EXCIPIENTS

Also contains: lactose monohydrate.

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Tablet

10 tablets

14 tablets

16 tablets

28 tablets

30 tablets

35 tablets

56 tablets

70 tablets

14 x 1 tablets

28 x 1 tablets

49 x 1 tablets

56 x 1 tablets

98 x 1 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

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1029/015 10 tablets

EU/1/15/1029/016 14 tablets

EU/1/15/1029/017 16 tablets

EU/1/15/1029/018 28 tablets

EU/1/15/1029/019 30 tablets

EU/1/15/1029/020 35 tablets

EU/1/15/1029/021 56 tablets

EU/1/15/1029/022 70 tablets

EU/1/15/1029/023 14 x 1 tablets

EU/1/15/1029/024 28 x 1 tablets

EU/1/15/1029/025 49 x 1 tablets

EU/1/15/1029/026 56 x 1 tablets

EU/1/15/1029/027 98 x 1 tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aripiprazole Sandoz 10 mg

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

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

Aripiprazole Sandoz 10 mg tablets aripiprazole

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Sandoz

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

OUTER CARTON FOR BOTTLE AND LABEL FOR BOTTLE

1. NAME OF THE MEDICINAL PRODUCT

Aripiprazole Sandoz 15 mg tablets aripiprazole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 15 mg of aripiprazole

3. LIST OF EXCIPIENTS

Also contains: lactose monohydrate.

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Tablet

100 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

Use within 3 months after first opening.

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

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1029/042

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Outer carton: Aripiprazole Sandoz 15 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

[Only Carton for bottle:]

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

[Only Carton for bottle:] PC: {number}

SN: {number} NN: {number}

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON FOR BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Aripiprazole Sandoz 15 mg tablets aripiprazole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 15 mg of aripiprazole

3. LIST OF EXCIPIENTS

Also contains: lactose monohydrate.

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Tablet

10 tablets

14 tablets

16 tablets

28 tablets

30 tablets

35 tablets

56 tablets

70 tablets

14 x 1 tablets

28 x 1 tablets

49 x 1 tablets

56 x 1 tablets

98 x 1 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

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1029/029 10 tablets

EU/1/15/1029/030 14 tablets

EU/1/15/1029/031 16 tablets

EU/1/15/1029/032 28 tablets

EU/1/15/1029/033 30 tablets

EU/1/15/1029/034 35 tablets

EU/1/15/1029/035 56 tablets

EU/1/15/1029/036 70 tablets

EU/1/15/1029/037 14 x 1 tablets

EU/1/15/1029/038 28 x 1 tablets

EU/1/15/1029/039 49 x 1 tablets

EU/1/15/1029/040 56 x 1 tablets

EU/1/15/1029/041 98 x 1 tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aripiprazole Sandoz 15 mg

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

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

Aripiprazole Sandoz 15 mg tablets aripiprazole

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Sandoz

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON FOR BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

Aripiprazole Sandoz 20 mg tablets aripiprazole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 20 mg of aripiprazole.

3. LIST OF EXCIPIENTS

Also contains: lactose monohydrate.

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Tablet

14 tablets

28 tablets

49 tablets

56 tablets

98 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

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1029/043 14 tablets

EU/1/15/1029/044 28 tablets

EU/1/15/1029/045 49 tablets

EU/1/15/1029/046 56 tablets

EU/1/15/1029/047 98 tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aripiprazole Sandoz 20 mg

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

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

Aripiprazole Sandoz 20 mg tablets aripiprazole

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Sandoz

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

OUTER CARTON FOR BOTTLE AND LABEL FOR BOTTLE

1. NAME OF THE MEDICINAL PRODUCT

Aripiprazole Sandoz 30 mg tablets aripiprazole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 30 mg of aripiprazole

3. LIST OF EXCIPIENTS

Also contains: lactose monohydrate.

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Tablet

100 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

Use within 3 months after first opening.

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

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1029/061

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Outer carton: Aripiprazole Sandoz 30 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

[Only Carton for bottle:]

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

[Only Carton for bottle:] PC: {number}

SN: {number} NN: {number}

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON FOR BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Aripiprazole Sandoz 30 mg tablets aripiprazole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 30 mg of aripiprazole

3. LIST OF EXCIPIENTS

Also contains: lactose monohydrate.

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Tablet

10 tablets

14 tablets

16 tablets

28 tablets

30 tablets

35 tablets

56 tablets

70 tablets

14 x 1 tablets

28 x 1 tablets

49 x 1 tablets

56 x 1 tablets

98 x 1 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

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1029/048 10 tablets

EU/1/15/1029/049 14 tablets

EU/1/15/1029/050 16 tablets

EU/1/15/1029/051 28 tablets

EU/1/15/1029/052 30 tablets

EU/1/15/1029/053 35 tablets

EU/1/15/1029/054 56 tablets

EU/1/15/1029/055 70 tablets

EU/1/15/1029/056 14 x 1 tablets

EU/1/15/1029/057 28 x 1 tablets

EU/1/15/1029/058 49 x 1 tablets

EU/1/15/1029/059 56 x 1 tablets

EU/1/15/1029/060 98 x 1 tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aripiprazole Sandoz 30 mg

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

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

Aripiprazole Sandoz 30 mg tablets aripiprazole

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Sandoz

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

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