Entecavir Sun
Italy
Table of Contents
- 1. NAME OF THE MEDICINAL PRODUCT
- 2. QUALITATIVE AND QUANTITATIVE COMPOSITION IN TERMS OF
- 3. LIST OF EXCIPIENTS
- 4. PHARMACEUTICAL FORM AND CONTENTS
- 5. METHOD AND ROUTE(S) OF ADMINISTRATION
- 6. SPECIAL PRECAUTION TO KEEP THE
- 9. SPECIAL PRECAUTIONS FOR STORAGE
- 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF THE
- 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
- 12. MARKETING AUTHORISATION NUMBER(S)
- 13. LOT NUMBER
- 17. UNIQUE IDENTIFIER – TWO-DIMENSIONAL BARCODE
- 18. UNIQUE IDENTIFIER - MACHINE-READABLE DATA
- 1. NAME OF THE MEDICINAL PRODUCT
- 2. QUALITATIVE AND QUANTITATIVE COMPOSITION IN TERMS OF
- 3. LIST OF EXCIPIENTS
- 4. PHARMACEUTICAL FORM AND CONTENTS
- 5. METHOD AND ROUTE(S) OF ADMINISTRATION
- 6. SPECIAL WARNING TO KEEP THE
- 9. SPECIAL STORAGE PRECAUTIONS
- 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF
- 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
- 12. MARKETING AUTHORISATION NUMBER(S)
- 13. BATCH NUMBER
- 1. NAME OF THE MEDICINAL PRODUCT
- 2. QUALITATIVE AND QUANTITATIVE COMPOSITION IN TERMS OF
- 3. LIST OF EXCIPIENTS
- 4. PHARMACEUTICAL FORM AND CONTENTS
- 5. METHOD AND ROUTE(S) OF ADMINISTRATION
- 6. SPECIAL PRECAUTION TO KEEP THE
- 9. SPECIAL STORAGE PRECAUTIONS
- 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINE OR WASTE DERIVED FROM SUCH MEDICINE, IF NECESSARY
- 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
- 12. MARKETING AUTHORISATION NUMBER(S)
- 13. BATCH NUMBER
- 17. UNIQUE IDENTIFIER – TWO-DIMENSIONAL BARCODE
- 18. UNIQUE IDENTIFIER - HUMAN READABLE DATA
- 1. NAME OF THE MEDICINAL PRODUCT
- 2. NAME OF THE MARKETING AUTHORISATION HOLDER
- 3. EXPIRY DATE
- 4. LOT NUMBER
- 5. OTHER
INFORMATION TO BE DISPLAYED ON THE SECONDARY PACKAGING
BOX (Bottle)
1. NAME OF THE MEDICINAL PRODUCT
Entecavir SUN 0.5 mg film-coated tablets
Entecavir SUN 1 mg film-coated tablets
entecavir
Generic medicinal product
2. QUALITATIVE AND QUANTITATIVE COMPOSITION IN TERMS OF
ACTIVE SUBSTANCE
Each film-coated tablet contains 0.5 mg of entecavir
Each film-coated tablet contains 1 mg of entecavir
3. LIST OF EXCIPIENTS
Contains lactose monohydrate. Read the package leaflet for further information.
4. PHARMACEUTICAL FORM AND CONTENTS
30 film-coated tablets
90 film-coated tablets
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Read the instruction leaflet before use.
For oral use.
6. SPECIAL PRECAUTION TO KEEP THE
MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN
Keep out of the sight and reach of children.
7. OTHER SPECIAL PRECAUTION(S), IF NECESSARY
8. EXPIRY DATE
Exp.
9. SPECIAL PRECAUTIONS FOR STORAGE
it-interpack-Entecavir SUN-v3
This medicinal product does not require any special storage conditions.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF THE
UNUSED MEDICINE OR WASTE DERIVED FROM SUCH MEDICINE, IF NECESSARY
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Sun Pharma Italia Srl
Viale Giulio Richard 3
20143 Milan
Italy
12. MARKETING AUTHORISATION NUMBER(S)
13. LOT NUMBER
Lot
14. GENERAL SUPPLY CONDITION
15. INSTRUCTIONS FOR USE
16. BRAILLE INFORMATION
entecavir 0.5 mg
entecavir 1 mg
17. UNIQUE IDENTIFIER – TWO-DIMENSIONAL BARCODE
Two-dimensional barcode including unique identifier
18. UNIQUE IDENTIFIER - MACHINE-READABLE DATA
PC: {number}
SN: {number}
NN: {number}
it-interpack-Entecavir SUN-v3
Price €
To be sold only upon presentation of a medical prescription valid for a single use issued by hospital centres or specialists (internist, infectious disease specialist, gastroenterologist).
May affect the ability to drive vehicles and operate machinery.
Package dispensed by the National Health Service (SSN)
it-interpack-Entecavir SUN-v3
INFORMATION TO BE PRINTED ON THE PRIMARY PACKAGING
LABEL (Vial)
1. NAME OF THE MEDICINAL PRODUCT
Entecavir SUN 0.5 mg film-coated tablets
Entecavir SUN 1 mg film-coated tablets
Entecavir
2. QUALITATIVE AND QUANTITATIVE COMPOSITION IN TERMS OF
ACTIVE SUBSTANCE
Each film-coated tablet contains 0.5 mg of entecavir
Each film-coated tablet contains 1 mg of entecavir
3. LIST OF EXCIPIENTS
Contains lactose monohydrate. Read the package leaflet for further information.
4. PHARMACEUTICAL FORM AND CONTENTS
30 film-coated tablets
90 film-coated tablets
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Read the package leaflet before use.
Oral use.
6. SPECIAL WARNING TO KEEP THE
MEDICINE 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 PRECAUTIONS
This medicinal product does not require any special storage conditions.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF
UNUSED MEDICINE OR WASTE DERIVED FROM SUCH
it-interpack-Entecavir SUN-v3
MEDICINE, IF NECESSARY
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
TO PLACE ON THE MARKET
Sun Pharma Italia Srl
viale Giulio Richard 3
20143 Milano
Italy
12. MARKETING AUTHORISATION NUMBER(S)
13. BATCH NUMBER
Batch
14. SUPPLY CONDITION
15. INSTRUCTIONS FOR USE
16. BRAILLE INFORMATION
it-interpack-Entecavir SUN-v3
INFORMATION TO APPEAR ON THE SECONDARY PACKAGING
BOX (Blister)
1. NAME OF THE MEDICINAL PRODUCT
Entecavir SUN 0.5 mg film-coated tablets
Entecavir SUN 1 mg film-coated tablets
entecavir
Generic medicine
2. QUALITATIVE AND QUANTITATIVE COMPOSITION IN TERMS OF
ACTIVE SUBSTANCE
Each film-coated tablet contains 0.5 mg of entecavir
Each film-coated tablet contains 1 mg of entecavir
3. LIST OF EXCIPIENTS
Contains lactose monohydrate.
4. PHARMACEUTICAL FORM AND CONTENTS
30 film-coated tablets
90 film-coated tablets
30 x 1 film-coated tablets
90 x 1 film-coated tablets
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Read the instruction leaflet before use.
Oral use.
6. SPECIAL PRECAUTION TO KEEP THE
MEDICINE OUT OF SIGHT AND REACH OF CHILDREN
Keep out of sight and reach of children.
7. OTHER SPECIAL PRECAUTION(S), IF NECESSARY
8. EXPIRY DATE
it-interpack-Entecavir SUN-v3
Exp.
9. SPECIAL STORAGE PRECAUTIONS
This medicinal product does not require any special storage conditions.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINE OR WASTE DERIVED FROM SUCH MEDICINE, IF NECESSARY
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
FOR PLACING ON THE MARKET
Sun Pharma Italia Srl
viale Giulio Richard 3
20143 Milano
Italy
12. MARKETING AUTHORISATION NUMBER(S)
13. BATCH NUMBER
Batch
14. GENERAL SUPPLY CONDITION
15. INSTRUCTIONS FOR USE
16. BRAILLE INFORMATION
entecavir 0.5 mg
entecavir 1 mg
17. UNIQUE IDENTIFIER – TWO-DIMENSIONAL BARCODE
Two-dimensional barcode including unique identifier
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA
it-interpack-Entecavir SUN-v3
PC: {number}
SN: {number}
NN: {number}
Price €
To be sold only upon presentation of a medical prescription valid for a single use, issued by hospital centres or specialists (internist, infectious disease specialist, gastroenterologist).
May impair the ability to drive vehicles and operate machinery.
Package dispensed by the National Health Service
it-interpack-Entecavir SUN-v3
MINIMUM INFORMATION TO BE INDICATED ON BLISTER OR STRIP
Blister
1. NAME OF THE MEDICINAL PRODUCT
Entecavir SUN 0.5 mg film-coated tablets
Entecavir SUN 1 mg film-coated tablets
2. NAME OF THE MARKETING AUTHORISATION HOLDER
IN COMMERCE
Sun Pharma Italia Srl
3. EXPIRY DATE
Exp.
4. LOT NUMBER
Lot No.
5. OTHER
it-interpack-Entecavir SUN-v3