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Plenadren (hydrocortisone) – Labelling - H02AB09

Updated on site: 09-Oct-2017

Medication namePlenadren
ATC CodeH02AB09
Substancehydrocortisone
ManufacturerShire Services BVBA

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF UNIT PACK

1.NAME OF THE MEDICINAL PRODUCT

Plenadren 5 mg modified-release tablets hydrocortisone

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each modified-release tablet contains hydrocortisone 5 mg.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

Modified-release tablet

50 modified-release tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Swallow the tablets whole. Do not divide, crush or chew tablets.

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

Shire Services BVBA

Rue Montoyer 47

B - 1000 Brussels

Belgium

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/11/715/001

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Plenadren 5 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 LABEL OF MULTIPACK (WITH BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Plenadren 5 mg modified-release tablets hydrocortisone

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each modified-release tablet contains hydrocortisone 5 mg.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Multipack: 100 (2 x 50) modified-release tablets

Multipack: 150 (3 x 50) modified-release tablets

Multipack: 300 (6 x 50) modified-release tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Swallow the tablets whole. Do not divide, crush or chew tablets.

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

Shire Services BVBA

Rue Montoyer 47

B - 1000 Brussels

Belgium

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/715/003 100 (2 x 50) modified-release tablets

EU/1/11/715/004 150 (3 x 50) modified-release tablets

EU/1/11/715/005 300 (6 x 50) modified-release tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Plenadren 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 SMALL IMMEDIATE PACKAGING UNITS

BOTTLE

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

Plenadren 5 mg modified-release tablets hydrocortisone

Oral use

2.METHOD OF ADMINISTRATION

Read the package leaflet before use.

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

50 modified-release tablets

6.OTHER

Shire Services BVBA

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF UNIT PACK

1. NAME OF THE MEDICINAL PRODUCT

Plenadren 20 mg modified-release tablets hydrocortisone

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each modified-release tablet contains hydrocortisone 20 mg.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Modified-release tablet

50 modified-release tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Swallow the tablets whole. Do not divide, crush or chew tablets.

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

Shire Services BVBA

Rue Montoyer 47

B - 1000 Brussels

Belgium

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/715/002

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Plenadren 20 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 LABEL OF MULTIPACK (WITH BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Plenadren 20 mg modified-release tablets hydrocortisone

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each modified-release tablet contains hydrocortisone 20 mg.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Multipack: 100 (2 x 50) modified-release tablets

Multipack: 150 (3 x 50) modified-release tablets

Multipack: 300 (6 x 50) modified-release tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Swallow the tablets whole, do not divide, crush or chew tablets.

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

Shire Services BVBA

Rue Montoyer 47

B - 1000 Brussels

Belgium

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/715/006 100 (2 x 50) modified-release tablets

EU/1/11/715/007 150 (3 x 50) modified-release tablets

EU/1/11/715/008 300 (6 x 50) modified-release tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Plenadren 20 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

BOTTLE

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

Plenadren 20 mg modified-release tablets hydrocortisone

Oral use

2. METHOD OF ADMINISTRATION

Read the package leaflet before use.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

50 modified-release tablets

6. OTHER

Shire Services BVBA

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