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Abilify (aripiprazole) – Labelling - N05AX12

Updated on site: 05-Oct-2017

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

ABILIFY 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.

4.PHARMACEUTICAL FORM AND CONTENTS

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

Store in the original package in order to protect from moisture.

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

Otsuka Pharmaceutical Europe Ltd.

Gallions, Wexham Springs, Framewood Road,

Wexham, SL3 6PJ - United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/04/276/001 (5 mg, 14 x 1 tablets)

EU/1/04/276/002 (5 mg, 28 x 1 tablets)

EU/1/04/276/003 (5 mg, 49 x 1 tablets)

EU/1/04/276/004 (5 mg, 56 x 1 tablets)

EU/1/04/276/005 (5 mg, 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

abilify 5 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

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

ABILIFY 5 mg tablets

aripiprazole

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Otsuka

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

ABILIFY 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.

4. PHARMACEUTICAL FORM AND CONTENTS

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

Store in the original package in order to protect from moisture.

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

Otsuka Pharmaceutical Europe Ltd.

Gallions, Wexham Springs, Framewood Road,

Wexham, SL3 6PJ - United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/04/276/006 (10 mg, 14 x 1 tablets)

EU/1/04/276/007 (10 mg, 28 x 1 tablets)

EU/1/04/276/008 (10 mg, 49 x 1 tablets)

EU/1/04/276/009 (10 mg, 56 x 1 tablets)

EU/1/04/276/010 (10 mg, 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

abilify 10 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

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

ABILIFY 10 mg tablets

aripiprazole

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Otsuka

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

ABILIFY 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.

4. PHARMACEUTICAL FORM AND CONTENTS

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

Store in the original package in order to protect from moisture.

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

Otsuka Pharmaceutical Europe Ltd.

Gallions, Wexham Springs, Framewood Road,

Wexham, SL3 6PJ - United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/04/276/011 (15 mg, 14 x 1 tablets)

EU/1/04/276/012 (15 mg, 28 x 1 tablets)

EU/1/04/276/013 (15 mg, 49 x 1 tablets)

EU/1/04/276/014 (15 mg, 56 x 1 tablets)

EU/1/04/276/015 (15 mg, 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

abilify 15 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

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

ABILIFY 15 mg tablets

aripiprazole

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Otsuka

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

ABILIFY 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.

4. PHARMACEUTICAL FORM AND CONTENTS

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

Store in the original package in order to protect from moisture.

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

Otsuka Pharmaceutical Europe Ltd.

Gallions, Wexham Springs, Framewood Road,

Wexham, SL3 6PJ - United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/04/276/016 (30 mg, 14 x 1 tablets)

EU/1/04/276/017 (30 mg, 28 x 1 tablets)

EU/1/04/276/018 (30 mg, 49 x 1 tablets)

EU/1/04/276/019 (30 mg, 56 x 1 tablets)

EU/1/04/276/020 (30 mg, 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

abilify 30 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

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

ABILIFY 30 mg tablets

aripiprazole

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Otsuka

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

ABILIFY 10 mg orodispersible tablets

aripiprazole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 10 mg of aripiprazole.

3. LIST OF EXCIPIENTS

Contains aspartame and lactose. See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

14 x 1 orodispersible tablets

28 x 1 orodispersible tablets

49 x 1 orodispersible 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

Store in the original package in order to protect from moisture.

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

Otsuka Pharmaceutical Europe Ltd.

Gallions, Wexham Springs, Framewood Road,

Wexham, SL3 6PJ - United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/04/276/024 (10 mg, 14 x 1 orodispersible tablets)

EU/1/04/276/025 (10 mg, 28 x 1 orodispersible tablets)

EU/1/04/276/026 (10 mg, 49 x 1 orodispersible tablets)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

abilify 10 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

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

ABILIFY 10 mg orodispersible tablets

aripiprazole

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Otsuka

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

ABILIFY 15 mg orodispersible tablets

aripiprazole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 15 mg of aripiprazole.

3. LIST OF EXCIPIENTS

Contains aspartame and lactose. See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

14 x 1 orodispersible tablets

28 x 1 orodispersible tablets

49 x 1 orodispersible 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

Store in the original package in order to protect from moisture.

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

Otsuka Pharmaceutical Europe Ltd.

Gallions, Wexham Springs, Framewood Road,

Wexham, SL3 6PJ - United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/04/276/027 (15 mg, 14 x 1 orodispersible tablets)

EU/1/04/276/028 (15 mg, 28 x 1 orodispersible tablets)

EU/1/04/276/029 (15 mg, 49 x 1 orodispersible tablets)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

abilify 15 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

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

ABILIFY 15 mg orodispersible tablets

aripiprazole

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Otsuka

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

ABILIFY 30 mg orodispersible tablets

aripiprazole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 30 mg of aripiprazole.

3. LIST OF EXCIPIENTS

Contains aspartame and lactose. See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

14 x 1 orodispersible tablets

28 x 1 orodispersible tablets

49 x 1 orodispersible 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

Store in the original package in order to protect from moisture.

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

Otsuka Pharmaceutical Europe Ltd.

Gallions, Wexham Springs, Framewood Road,

Wexham, SL3 6PJ - United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/04/276/030 (30 mg, 14 x 1 orodispersible tablets)

EU/1/04/276/031 (30 mg, 28 x 1 orodispersible tablets)

EU/1/04/276/032 (30 mg, 49 x 1 orodispersible tablets)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

abilify 30 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

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

ABILIFY 30 mg orodispersible tablets

aripiprazole

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Otsuka

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

OUTER CARTON AND BOTTLE LABEL

1. NAME OF THE MEDICINAL PRODUCT

ABILIFY 1 mg/ml oral solution

aripiprazole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each ml contains 1 mg of aripiprazole.

3. LIST OF EXCIPIENTS

Contains fructose, sucrose, E218, and E216.

4. PHARMACEUTICAL FORM AND CONTENTS

50 ml oral solution

150 ml oral solution

480 ml oral solution

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 6 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

Outer carton:

Otsuka Pharmaceutical Europe Ltd.

Gallions, Wexham Springs, Framewood Road,

Wexham, SL3 6PJ - United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/04/276/033 - 50 ml bottle

EU/1/04/276/034 - 150 ml bottle

EU/1/04/276/035 - 480 ml bottle

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: abilify 1 mg/ml

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

1. NAME OF THE MEDICINAL PRODUCT

ABILIFY 7.5 mg/ml solution for injection

aripiprazole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each ml contains 7.5 mg of aripiprazole. A vial provides 9.75 mg in 1.3 ml.

3. LIST OF EXCIPIENTS

Also contains sulfobutylether b-cyclodextrin, tartaric acid, sodium hydroxide, and water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection 1 vial

9.75 mg / 1.3 ml

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Intramuscular 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

Keep the vial 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

Otsuka Pharmaceutical Europe Ltd.

Gallions, Wexham Springs, Framewood Road,

Wexham, SL3 6PJ - United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/04/276/036

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted.

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 LABEL

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

ABILIFY 7.5 mg/ml solution for injection

aripiprazole

IM use

2.METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

9.75 mg / 1.3 ml

6.OTHER

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