Bulgarian 
Croatian
Czech 
Danish
Dutch
Estonian
Finnish
French
German
Greek
Hungarian
Icelandic
Italian
Latvian
Lithuanian
Maltese
Norwegian
Polish
Portuguese 
Romanian
Slovak
Slovenian
Spanish
SwedishArticle Contents
- 1. NAME OF THE MEDICINAL PRODUCT
- 2. STATEMENT OF ACTIVE SUBSTANCE(S)
- 3. LIST OF EXCIPIENTS
- 4. PHARMACEUTICAL FORM AND CONTENTS
- 5. METHOD AND ROUTE(S) OF ADMINISTRATION
- 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
- 7. OTHER SPECIAL WARNING(S), IF NECESSARY
- 8. EXPIRY DATE
- 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
- 12. MARKETING AUTHORISATION NUMBER(S)
- 13. BATCH NUMBER
- 14. GENERAL CLASSIFICATION FOR SUPPLY
- 15. INSTRUCTIONS ON USE
- 16. INFORMATION IN BRAILLE
- 17. UNIQUE IDENTIFIER – 2D BARCODE
- 18. UNIQUE IDENTIFIER – HUMAN READABLE DATA
- 2. NAME OF THE MARKETING AUTHORISATION HOLDER
- 3. EXPIRY DATE
- 4. BATCH NUMBER
- 5. OTHER
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Oral solution - Carton of multipack containing 300 ml (5 bottles 60 ml) oral solution – including blue box
1.NAME OF THE MEDICINAL PRODUCT
Kaletra (80 mg + 20 mg) / ml oral solution (lopinavir + ritonavir)
2.STATEMENT OF ACTIVE SUBSTANCE(S)
Each ml contains: lopinavir 80 mg and ritonavir 20 mg (pharmacokinetic enhancer).
3.LIST OF EXCIPIENTS
Includes: alcohol, high fructose corn syrup, propylene glycol, glycerol, polyoxyl 40 hydrogenated castor oil, potassium (as acesulfame potassium).
4.PHARMACEUTICAL FORM AND CONTENTS
Multipack: 300 ml (5 bottles of 60 ml each) 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
Child resistant closure
8.EXPIRY DATE
EXP
9.SPECIAL STORAGE CONDITIONS
Store in a refrigerator
In use storage: If kept outside of the refrigerator, do not store above 25°C and discard any unused contents after 42 days (6 weeks). It is advised to write the date of removal from the refrigerator on the package.
Avoid exposure to excessive heat.
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
AbbVie Ltd
Maidenhead
SL6 4UB
United Kingdom
12.MARKETING AUTHORISATION NUMBER(S)
EU/1/01/172/003
13.BATCH NUMBER
Lot
14.GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15.INSTRUCTIONS ON USE
16.INFORMATION IN BRAILLE
Kaletra (80 mg + 20 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 IMMEDIATE PACKAGING
Oral Solution – Bottle label
1. NAME OF THE MEDICINAL PRODUCT
Kaletra (80 mg + 20 mg) / ml oral solution (lopinavir + ritonavir)
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each ml contains lopinavir 80 mg and ritonavir 20 mg (pharmacokinetic enhancer).
3. LIST OF EXCIPIENTS
Includes: alcohol (42 % v/v see leaflet), high fructose corn syrup, propylene glycol, glycerol, polyoxyl 40 hydrogenated castor oil, potassium (as acesulfame potassium).
4. PHARMACEUTICAL FORM AND CONTENTS
60 ml oral solution
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Read the package leaflet before use.
Oral use
Important to open
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
Child resistant closure
8. EXPIRY DATE
EXP
9. SPECIAL STORAGE CONDITIONS
Store in a refrigerator
In use storage: If kept outside of the refrigerator, do not store above 25°C and discard any unused contents after 42 days (6 weeks). It is advised to write the date of removal from the refrigerator on the package.
Avoid exposure to excessive heat.
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
AbbVie Ltd
Maidenhead
SL6 4UB
United Kingdom
12. MARKETING AUTHORISATION NUMBER(S)
EU/1/01/172/003
13. BATCH NUMBER
Lot
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
17. UNIQUE IDENTIFIER – 2D BARCODE
Not applicable
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA
Not applicable
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 200 mg/50 mg tablets – Carton of 1 bottle
1. NAME OF THE MEDICINAL PRODUCT
Kaletra 200 mg/50 mg
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each
3. LIST OF EXCIPIENTS
4. PHARMACEUTICAL FORM AND CONTENTS
120
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
AbbVie Ltd
Maidenhead
SL6 4UB
United Kingdom
12. MARKETING AUTHORISATION NUMBER(S)
EU/1/01/172/004
13. BATCH NUMBER
Lot
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Kaletra 200 mg/50 mg tablets
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
200 mg/50 mg Tablets – Carton of multipack containing 360 (3 bottles of 120)
– including blue box
1. NAME OF THE MEDICINAL PRODUCT
Kaletra 200 mg/50 mg
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each
3. LIST OF EXCIPIENTS
4. PHARMACEUTICAL FORM AND CONTENTS
Multipack: 360 (3 bottles of 120)
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
AbbVie Ltd
Maidenhead
SL6 4UB
United Kingdom
12. MARKETING AUTHORISATION NUMBER(S)
EU/1/01/172/007
13. BATCH NUMBER
Lot
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Kaletra 200 mg/50 mg tablets
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 ON THE IMMEDIATE PACKAGING 200 mg/50 mg tablets – Bottle label
1. NAME OF THE MEDICINAL PRODUCT
Kaletra 200 mg/50 mg
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each
3. LIST OF EXCIPIENTS
4. PHARMACEUTICAL FORM AND CONTENTS
120
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
- Exviera - AbbVie Ltd
- Venclyxto - AbbVie Ltd
- Humira - AbbVie Ltd
- Synagis - AbbVie Ltd
- Norvir - AbbVie Ltd
Prescription drugs listed. Manufacturer: "AbbVie Ltd"
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
AbbVie Ltd
Maidenhead
SL6 4UB
United Kingdom
12. MARKETING AUTHORISATION NUMBER(S)
EU/1/01/172/004
EU/1/01/172/007
13. BATCH NUMBER
Lot
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
17. UNIQUE IDENTIFIER – 2D BARCODE
Not applicable
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA
Not applicable
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Outer carton of multipacks of 120 (3 cartons of 40
Carton of blister pack containing 120 200 mg/50 mg
1. NAME OF THE MEDICINAL PRODUCT
Kaletra 200 mg/50 mg
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each
3. LIST OF EXCIPIENTS
4. PHARMACEUTICAL FORM AND CONTENTS
Multipack: 120 (3 packs of 40)
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
AbbVie Ltd
Maidenhead
SL6 4UB
United Kingdom
12. MARKETING AUTHORISATION NUMBER(S)
EU/1/01/172/005 – multipack: 120 (3 packs of 40)
EU/1/01/172/008 – carton of 120
13. BATCH NUMBER
Lot
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Kaletra 200 mg/50 mg tablets
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 INTERMEDIATE CARTON
Inner carton of multipack of 120 (3 packs of 40) 200 mg/50 mg
1. NAME OF THE MEDICINAL PRODUCT
Kaletra 200 mg/50 mg
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each
3. LIST OF EXCIPIENTS
4. PHARMACEUTICAL FORM AND CONTENTS
40
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
AbbVie Ltd
Maidenhead
SL6 4UB
United Kingdom
12. MARKETING AUTHORISATION NUMBER(S)
EU/1/01/172/005
13. BATCH NUMBER
Lot
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Kaletra 200 mg/50 mg tablets
17. UNIQUE IDENTIFIER – 2D BARCODE
Not applicable
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA
Not applicable
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
200 mg/50 mg tablets – Blister of 8
1. NAME OF THE MEDICINAL PRODUCT
Kaletra 200 mg/50 mg
2.NAME OF THE MARKETING AUTHORISATION HOLDER
AbbVie Ltd
3.EXPIRY DATE
EXP
4.BATCH NUMBER
Lot
5.OTHER
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 100 mg/ 25 mg tablets – Carton of 1 bottle
1. NAME OF THE MEDICINAL PRODUCT
Kaletra 100 mg/25 mg
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each
3. LIST OF EXCIPIENTS
4. PHARMACEUTICAL FORM AND CONTENTS
60
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
AbbVie Ltd
Maidenhead
SL6 4UB
United Kingdom
12. MARKETING AUTHORISATION NUMBER(S)
EU/1/01/172/006
13. BATCH NUMBER
Lot
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Kaletra 100 mg/25 mg tablets
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 ON THE IMMEDIATE PACKAGING 100 mg/25 mg tablets - bottle label
1. NAME OF THE MEDICINAL PRODUCT
Kaletra 100 mg/25 mg
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each
3. LIST OF EXCIPIENTS
4. PHARMACEUTICAL FORM AND CONTENTS
60
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
AbbVie Ltd
Maidenhead
SL6 4UB
United Kingdom
12. MARKETING AUTHORISATION NUMBER(S)
EU/1/01/172/006
13. BATCH NUMBER
Lot
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
17. UNIQUE IDENTIFIER – 2D BARCODE
Not applicable
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA
Not applicable
Comments
