Ticagrelor aurovitas
PolandTable of Contents
- 1. NAME OF THE MEDICINAL PRODUCT
- 2. COMPOSITION OF THE ACTIVE SUBSTANCE
- 3. LIST OF EXCIPIENTS
- 4. PHARMACEUTICAL FORM AND PACKAGE CONTENTS
- 5. METHOD AND ROUTE OF ADMINISTRATION
- 6. WARNING ON STORAGE OF THE MEDICINAL PRODUCT
- 11. NAME AND ADDRESS OF THE RESPONSIBLE ENTITY
- 12. MARKETING AUTHORISATION NUMBER
- 13. BATCH NUMBER
- 14. GENERAL AVAILABILITY CATEGORY
- 17. UNIQUE IDENTIFIER – 2D CODE
- 18. UNIQUE IDENTIFIER – HUMAN-READABLE DATA
- 1. NAME OF THE MEDICINAL PRODUCT
- 2. NAME OF THE MARKETING AUTHORISATION HOLDER
- 3. EXPIRY DATE
- 4. BATCH NUMBER
- 5. OTHERS
- 1. NAME OF THE MEDICINAL PRODUCT
- 2. NAME OF THE MARKETING AUTHORISATION HOLDER
- 3. EXPIRY DATE
- 4. BATCH NUMBER
- 5. OTHER
- 1. NAME OF THE MEDICINAL PRODUCT
- 2. COMPOSITION OF THE ACTIVE SUBSTANCE
- 3. LIST OF EXCIPIENTS
- 4. PHARMACEUTICAL FORM AND PACKAGE CONTENTS
- 5. METHOD AND ROUTE OF ADMINISTRATION
- 6. WARNINGS ON STORAGE OF THE MEDICINAL PRODUCT
- 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
- 12. MARKETING AUTHORISATION NUMBER
- 13. LOT NUMBER
- 14. GENERAL AVAILABILITY CATEGORY
- 17. UNIQUE IDENTIFIER – 2D CODE
- 18. UNIQUE IDENTIFIER – HUMAN-READABLE DATA
- 1. NAME OF THE MEDICINAL PRODUCT
- 2. COMPOSITION OF THE ACTIVE SUBSTANCE
- 3. LIST OF EXCIPIENTS
- 4. PHARMACEUTICAL FORM AND PACKAGE CONTENTS
- 5. METHOD AND ROUTE OF ADMINISTRATION
- 6. WARNING ON STORAGE OF THE MEDICINAL PRODUCT
- 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
- 12. MARKETING AUTHORISATION NUMBER
- 13. LOT NUMBER
- 14. GENERAL AVAILABILITY CATEGORY
INFORMATION ON OUTER PACKAGING
CARDBOARD BOX (FOR BLISTER AND CALENDAR BLISTER)
1. NAME OF THE MEDICINAL PRODUCT
Ticagrelor Aurovitas, 60 mg, film-coated tablets
Ticagrelorum
2. COMPOSITION OF THE ACTIVE SUBSTANCE
Each coated tablet contains 60 mg of ticagrelor.
3. LIST OF EXCIPIENTS
Contains monohydrate lactose, additional information - see package leaflet.
4. PHARMACEUTICAL FORM AND PACKAGE CONTENTS
Film-coated tablet
Blister
- GTIN number: 14 film-coated tablets
- GTIN number: 30 film-coated tablets
- GTIN number: 56 film-coated tablets
- GTIN number: 60 film-coated tablets
- GTIN number: 90 film-coated tablets
- GTIN number: 100 film-coated tablets
- GTIN number: 168 film-coated tablets
- GTIN number: 180 film-coated tablets
- GTIN number: 200 film-coated tablets
Calendar blister
- GTIN number: 14 film-coated tablets
- GTIN number: 56 film-coated tablets
- GTIN number: 168 film-coated tablets
5. METHOD AND ROUTE OF ADMINISTRATION
Oral administration.
Read the instruction leaflet before using the medicine.
6. WARNING ON STORAGE OF THE MEDICINAL PRODUCT
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
Keep the medicinal product out of the sight and reach of children.
7. OTHER SPECIAL WARNINGS, IF NECESSARY
8. EXPIRY DATE
EXP:
EXP = Expiry date
9. SPECIAL STORAGE CONDITIONS
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCT OR WASTE MATERIAL DERIVING FROM SUCH MEDICINAL PRODUCT, IF APPROPRIATE
11. NAME AND ADDRESS OF THE RESPONSIBLE ENTITY
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa Street 13D, Unit 27
01-909 Warsaw
12. MARKETING AUTHORISATION NUMBER
Authorisation number:
13. BATCH NUMBER
Lot:
Lot = Batch number
14. GENERAL AVAILABILITY CATEGORY
Rp - Medicinal product supplied on prescription only.
15. INSTRUCTIONS FOR USE
16. INFORMATION PROVIDED IN BRAILLE
ticagrelor aurovitas 60 mg
17. UNIQUE IDENTIFIER – 2D CODE
Includes a 2D code serving as the carrier of the unique identifier.
18. UNIQUE IDENTIFIER – HUMAN-READABLE DATA
PC:
SN:
NN:
MINIMUM INFORMATION ON BLISTER PACKS OR
FILM PACKAGING
BLISTER
1. NAME OF THE MEDICINAL PRODUCT
Ticagrelor Aurovitas, 60 mg, film-coated tablets
Ticagrelorum
2. NAME OF THE MARKETING AUTHORISATION HOLDER
Aurovitas Pharma Polska Sp. z o.o.
3. EXPIRY DATE
EXP:
4. BATCH NUMBER
Lot:
5. OTHERS
MINIMUM INFORMATION TO BE DISPLAYED ON BLISTER PACKS OR
ALUMINUM FOIL PACKS
CALENDAR BLISTER
1. NAME OF THE MEDICINAL PRODUCT
Ticagrelor Aurovitas, 60 mg, coated tablets
Ticagrelorum
2. NAME OF THE MARKETING AUTHORISATION HOLDER
Aurovitas Pharma Polska Sp. z o.o.
3. EXPIRY DATE
EXP:
4. BATCH NUMBER
Lot:
5. OTHER
Mon Tue Wed Thu Fri Sat Sun
Sun/Moon Symbol
INFORMATION ON OUTER PACKAGING
CARDBOARD BOX (FOR BOTTLE)
1. NAME OF THE MEDICINAL PRODUCT
Ticagrelor Aurovitas, 60 mg, coated tablets
Ticagrelorum
2. COMPOSITION OF THE ACTIVE SUBSTANCE
Each coated tablet contains 60 mg of ticagrelor.
3. LIST OF EXCIPIENTS
Contains monohydrate lactose, additional information - see package leaflet.
4. PHARMACEUTICAL FORM AND PACKAGE CONTENTS
Film-coated tablet
- GTIN number: 250 film-coated tablets
- GTIN number: 500 film-coated tablets
5. METHOD AND ROUTE OF ADMINISTRATION
Oral administration.
Read the instruction leaflet before use.
6. WARNINGS ON STORAGE OF THE MEDICINAL PRODUCT
KEEP OUT OF SIGHT AND REACH OF CHILDREN
Keep the medicine out of sight and reach of children.
7. OTHER SPECIAL WARNINGS, IF NECESSARY
8. EXPIRY DATE
EXP:
EXP = Expiry date
9. SPECIAL STORAGE CONDITIONS
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCT OR
WASTE MATERIAL DERIVING FROM SUCH MEDICINAL PRODUCT, IF APPROPRIATE
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa Street 13D, local 27
01-909 Warsaw
12. MARKETING AUTHORISATION NUMBER
Authorisation number:
13. LOT NUMBER
Lot:
Lot = Lot number
14. GENERAL AVAILABILITY CATEGORY
Rp - Medicinal product subject to medical prescription.
15. INSTRUCTIONS FOR USE
16. INFORMATION IN BRAILLE
ticagrelor aurovitas 60 mg
17. UNIQUE IDENTIFIER – 2D CODE
Includes a 2D code serving as the carrier of the unique identifier.
18. UNIQUE IDENTIFIER – HUMAN-READABLE DATA
PC:
SN:
NN:
MINIMUM INFORMATION TO BE PLACED ON SMALL
PRIMARY PACKAGING
LABEL FOR BOTTLE
1. NAME OF THE MEDICINAL PRODUCT
Ticagrelor Aurovitas, 60 mg, film-coated tablets
Ticagrelorum
2. COMPOSITION OF THE ACTIVE SUBSTANCE
Each coated tablet contains 60 mg of ticagrelor.
3. LIST OF EXCIPIENTS
Contains monohydrate lactose, additional information - see package leaflet.
4. PHARMACEUTICAL FORM AND PACKAGE CONTENTS
Film-coated tablet
250 film-coated tablets
500 film-coated tablets
5. METHOD AND ROUTE OF ADMINISTRATION
Oral use.
Read the instruction leaflet before using the medicine.
6. WARNING ON STORAGE OF THE MEDICINAL PRODUCT
KEEP OUT OF SIGHT AND REACH OF CHILDREN
Keep the medicine in a place out of sight and reach of children.
7. OTHER SPECIAL WARNINGS, IF NECESSARY
8. EXPIRY DATE
EXP:
9. SPECIAL STORAGE CONDITIONS
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED
MEDICINAL PRODUCT OR WASTE DERIVED FROM IT, IF
APPLICABLE
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Aurovitas Pharma Polska Sp. z o.o.
12. MARKETING AUTHORISATION NUMBER
Authorisation number:
13. LOT NUMBER
Lot:
14. GENERAL AVAILABILITY CATEGORY
Rp - Prescription-only medicine.
15. INSTRUCTIONS FOR USE
16. INFORMATION IN BRAILLE
17. UNIQUE IDENTIFIER – 2D CODE
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA