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Advagraf (tacrolimus) – Labelling - L04AD02

Updated on site: 05-Oct-2017

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON Advagraf 0.5 mg prolonged-release hard capsules

1.NAME OF THE MEDICINAL PRODUCT

Advagraf 0.5 mg prolonged-release hard capsules

Tacrolimus

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each capsule contains 0.5 mg tacrolimus (as monohydrate).

3.LIST OF EXCIPIENTS

Also contains lactose and traces of soya lecithin. See package leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

30 prolonged-release hard capsules 30×1 prolonged-release hard capsules 50 prolonged-release hard capsules 50×1 prolonged-release hard capsules 100 prolonged-release hard capsules 100×1 prolonged-release hard capsules

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Once daily.

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

Do not swallow the desiccant.

8.EXPIRY DATE

EXP

Use all the capsules within 1 year of opening the aluminium wrapping and before the expiry date.

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

Astellas Pharma Europe B.V.

Sylviusweg 62

2333 BE Leiden

Netherlands

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/07/387/001 30 capsules

EU/1/07/387/002 50 capsules

EU/1/07/387/009 100 capsules

EU/1/07/387/014 30×1 capsules

EU/1/07/387/015 50×1 capsules

EU/1/07/387/016 100×1 capsules

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Advagraf 0.5 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER Advagraf 0.5 mg prolonged-release hard capsules

1. NAME OF THE MEDICINAL PRODUCT

Advagraf 0.5 mg prolonged-release hard capsules

Tacrolimus

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Astellas Pharma Europe B.V.

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Batch

5.OTHER

Once daily.

MINIMUM PARTICULARS TO APPEAR ON BLISTER WRAPPERS

ALUMINIUM WRAPPER Advagraf 0.5 mg prolonged-release hard capsules (30, 50, 100 Aluminium Wrapper)

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

Advagraf 0.5 mg prolonged-release hard capsules

Tacrolimus

Oral use.

2.METHOD OF ADMINISTRATION

Read the package leaflet before use.

3. EXPIRY DATE

EXP

Use all the capsules within 1 year of opening the aluminium wrapping and before the expiry date.

4. BATCH NUMBER

Batch

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

30 prolonged-release hard capsules 30×1 prolonged-release hard capsules 50 prolonged-release hard capsules 50×1 prolonged-release hard capsules 100 prolonged-release hard capsules 100 1 prolonged-release hard capsules

6.OTHER

Once daily.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON Advagraf 1 mg prolonged-release hard capsules

1. NAME OF THE MEDICINAL PRODUCT

Advagraf 1 mg prolonged-release hard capsules

Tacrolimus

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each capsule contains 1 mg tacrolimus (as monohydrate).

3. LIST OF EXCIPIENTS

Also contains lactose and traces of soya lecithin. See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

30 prolonged-release hard capsules 30×1 prolonged-release hard capsules 50 prolonged-release hard capsules 50×1 prolonged-release hard capsules 60 prolonged-release hard capsules 60×1 prolonged-release hard capsules 100 prolonged-release hard capsules 100×1 prolonged-release hard capsules

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Once daily.

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

Do not swallow the desiccant.

8. EXPIRY DATE

EXP

Use all the capsules within 1 year of opening the aluminium wrapping and before the expiry date.

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

Astellas Pharma Europe B.V.

Sylviusweg 62

2333 BE Leiden

Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/387/003 30 capsules

EU/1/07/387/004 50 capsules

EU/1/07/387/005 60 capsules

EU/1/07/387/006 100 capsules

EU/1/07/387/017 30×1 capsules

EU/1/07/387/018 50×1 capsules

EU/1/07/387/019 60×1 capsules

EU/1/07/387/020 100×1 capsules

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Advagraf 1 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER Advagraf 1 mg prolonged-release hard capsules

1. NAME OF THE MEDICINAL PRODUCT

Advagraf 1 mg prolonged-release hard capsules

Tacrolimus

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Astellas Pharma Europe B.V.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Batch

5. OTHER

Once daily.

MINIMUM PARTICULARS TO APPEAR ON BLISTER WRAPPERS

ALUMINIUM WRAPPER Advagraf 1 mg prolonged-release hard capsules (30, 50, 60, 100 Aluminium Wrapper)

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

Advagraf 1 mg prolonged-release hard capsules

Tacrolimus

Oral use.

2. METHOD OF ADMINISTRATION

Read the package leaflet before use.

3. EXPIRY DATE

EXP

Use all the capsules within 1 year of opening the aluminium wrapping and before the expiry date.

4. BATCH NUMBER

Batch

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

30 prolonged-release hard capsules 30×1 prolonged-release hard capsules 50 prolonged-release hard capsules 50×1 prolonged-release hard capsules 60 prolonged-release hard capsules 60×1 prolonged-release hard capsules 100 prolonged-release hard capsules 100×1 prolonged-release hard capsules

6. OTHER

Once daily.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON Advagraf 3 mg prolonged-release hard capsules

1. NAME OF THE MEDICINAL PRODUCT

Advagraf 3 mg prolonged-release hard capsules

Tacrolimus

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each capsule contains 3 mg tacrolimus (as monohydrate).

3. LIST OF EXCIPIENTS

Also contains lactose and traces of soya lecithin. See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

30 prolonged-release hard capsules 30×1 prolonged-release hard capsules 50 prolonged-release hard capsules 50×1 prolonged-release hard capsules 100 prolonged-release hard capsules 100×1 prolonged-release hard capsules

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Once daily.

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

Do not swallow the desiccant.

8. EXPIRY DATE

EXP

Use all the capsules within 1 year of opening the aluminium wrapping and before the expiry date.

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

Astellas Pharma Europe B.V.

Sylviusweg 62

2333 BE Leiden

Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/387/011 30 capsules

EU/1/07/387/012 50 capsules

EU/1/07/387/013 100 capsules

EU/1/07/387/021 30×1 capsules

EU/1/07/387/022 50×1 capsules

EU/1/07/387/023 100×1 capsules

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Advagraf 3 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER Advagraf 3 mg prolonged-release hard capsules

1. NAME OF THE MEDICINAL PRODUCT

Advagraf 3 mg prolonged-release hard capsules

Tacrolimus

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Astellas Pharma Europe B.V.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Batch

5. OTHER

Once daily.

MINIMUM PARTICULARS TO APPEAR ON BLISTER WRAPPERS

ALUMINIUM WRAPPER Advagraf 3 mg prolonged-release hard capsules (30, 50, 100 Aluminium Wrapper)

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

Advagraf 3 mg prolonged-release hard capsules

Tacrolimus

Oral use.

2. METHOD OF ADMINISTRATION

Read the package leaflet before use.

3. EXPIRY DATE

EXP

Use all the capsules within 1 year of opening the aluminium wrapping and before the expiry date.

4. BATCH NUMBER

Batch

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

30 prolonged-release hard capsules 30×1 prolonged-release hard capsules 50 prolonged-release hard capsules 50×1 prolonged-release hard capsules 100 prolonged-release hard capsules 100×1 prolonged-release hard capsules

6. OTHER

Once daily.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON Advagraf 5 mg prolonged-release hard capsules

1. NAME OF THE MEDICINAL PRODUCT

Advagraf 5 mg prolonged-release hard capsules

Tacrolimus

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each capsule contains 5 mg tacrolimus (as monohydrate).

3. LIST OF EXCIPIENTS

Also contains lactose and traces of soya lecithin. See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

30 prolonged-release hard capsules 30×1 prolonged-release hard capsules 50 prolonged-release hard capsules 50×1 prolonged-release hard capsules 100 prolonged-release hard capsules 100×1 prolonged-release hard capsules

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Once daily.

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

Do not swallow the desiccant.

8. EXPIRY DATE

EXP

Use all the capsules within 1 year of opening the aluminium wrapping and before the expiry date.

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

Astellas Pharma Europe B.V.

Sylviusweg 62

2333 BE Leiden

Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/387/007 30 capsules

EU/1/07/387/008 50 capsules

EU/1/07/387/010 100 capsules

EU/1/07/387/024 30×1 capsules

EU/1/07/387/025 50×1 capsules

EU/1/07/387/026 100×1 capsules

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Advagraf 5 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER Advagraf 5 mg prolonged-release hard capsules

1. NAME OF THE MEDICINAL PRODUCT

Advagraf 5 mg prolonged-release hard capsules

Tacrolimus

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Astellas Pharma Europe B.V.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Batch

5. OTHER

Once daily.

MINIMUM PARTICULARS TO APPEAR ON BLISTER WRAPPERS

ALUMINIUM WRAPPER Advagraf 5 mg prolonged-release hard capsules (30, 50, 100 Aluminium Wrapper)

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

Advagraf 5 mg prolonged-release hard capsules

Tacrolimus

Oral use.

2. METHOD OF ADMINISTRATION

Read the package leaflet before use.

3. EXPIRY DATE

EXP

Use all the capsules within 1 year of opening the aluminium wrapping and before the expiry date.

4. BATCH NUMBER

Batch

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

30 prolonged-release hard capsules 30×1 prolonged-release hard capsules 50 prolonged-release hard capsules 50×1 prolonged-release hard capsules 100 prolonged-release hard capsules 100 1 prolonged-release hard capsules

6. OTHER

Once daily.

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