Posaconazole Zentiva
ItalyTable of Contents
- 1. NAME OF THE MEDICINAL PRODUCT
- 2. QUALITATIVE AND QUANTITATIVE COMPOSITION IN TERMS OF ACTIVE SUBSTANCE(S)
- 5. METHOD AND ROUTE(S) OF ADMINISTRATION
- 6. SPECIAL PRECAUTION TO KEEP THE MEDICINAL PRODUCT
- 7. OTHER PARTICULAR WARNING(S), IF NECESSARY
- 8. EXPIRY DATE
- 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
- 12. MARKETING AUTHORISATION NUMBERS
- 13. BATCH NUMBER
- 17. UNIQUE IDENTIFIER – TWO-DIMENSIONAL BARCODE
- 18. UNIQUE IDENTIFIER – READABLE DATA
- 1. NAME OF THE MEDICINAL PRODUCT
- 2. NAME OF THE MARKETING AUTHORISATION HOLDER
- 3. EXPIRY DATE
- 4. LOT NUMBER
- 5. OTHER
- 1. NAME OF THE MEDICINAL PRODUCT
- 2. NAME OF THE MARKETING AUTHORISATION HOLDER
- 3. EXPIRY DATE
- 4. LOT NUMBER
- 5. OTHER INFORMATION
INFORMATION TO BE INCLUDED ON THE SECONDARY AND PRIMARY PACKAGING
LABEL FOR BOTTLE AND CARTON BOX (BLISTER AND BOTTLES)
1. NAME OF THE MEDICINAL PRODUCT
Posaconazole Zentiva 100 mg gastro-resistant tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION IN TERMS OF ACTIVE SUBSTANCE(S)
Each gastro-resistant tablet contains 100 mg of posaconazole.
3. LIST OF EXCIPIENTS
4. PHARMACEUTICAL FORM AND CONTENT
Blister:
24 gastro-resistant tablets
96 gastro-resistant tablets
24x1 gastro-resistant tablets
96x1 gastro-resistant tablets
Bottles:
60 gastro-resistant tablets
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Read the instruction leaflet before use.
Oral use.
6. SPECIAL PRECAUTION TO KEEP THE MEDICINAL PRODUCT
OUT OF THE SIGHT AND REACH OF CHILDREN
Keep out of the sight and reach of children.
7. OTHER PARTICULAR WARNING(S), IF NECESSARY
Posaconazole delayed-release tablets and posaconazole oral suspension are NOT interchangeable.
8. EXPIRY DATE
Exp.
9. SPECIAL PRECAUTIONS FOR STORAGE
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINE OR
WASTE MATERIALS DERIVING FROM SUCH MEDICINE, IF
NECESSARY
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Zentiva Italia Srl
Viale L. Bodio, 37/B
20158 Milano
Italy
12. MARKETING AUTHORISATION NUMBERS
049469012 - "100 MG GASTRO-RESISTANT TABLETS" 24 TABLETS IN BLISTER
AL/AL
049469024 - "100 MG GASTRO-RESISTANT TABLETS" 96 TABLETS IN BLISTER
AL/AL
049469036 - "100 MG GASTRO-RESISTANT TABLETS" 24 TABLETS IN BLISTER
AL/AL DIVIDED INTO SINGLE DOSES
049469048 - "100 MG GASTRO-RESISTANT TABLETS" 96 TABLETS IN BLISTER
AL/AL DIVIDED INTO SINGLE DOSES
049469051 - "100 MG GASTRO-RESISTANT TABLETS" 24 TABLETS IN BLISTER
PVC/PCTFE/AL
049469063 - "100 MG GASTRO-RESISTANT TABLETS" 96 TABLETS IN BLISTER
PVC/PCTFE/AL
049469075 - "100 MG GASTRO-RESISTANT TABLETS" 24 TABLETS IN BLISTER
PVC/PCTFE/AL DIVIDED INTO SINGLE DOSES
049469087 - "100 MG GASTRO-RESISTANT TABLETS" 96 TABLETS IN BLISTER
PVC/PCTFE/AL DIVIDED INTO SINGLE DOSES
049469099 - "100 MG GASTRO-RESISTANT TABLETS" 24 TABLETS IN BLISTER
PVC/PE/PVDC/AL
049469101 - "100 MG GASTRO-RESISTANT TABLETS" 96 TABLETS IN BLISTER
PVC/PE/PVDC/AL
049469113 - "100 MG GASTRO-RESISTANT TABLETS" 24 TABLETS IN BLISTER
PVC/PE/PVDC/AL DIVIDED INTO SINGLE DOSES
049469125 - "100 MG GASTRO-RESISTANT TABLETS" 96 TABLETS IN BLISTER
PVC/PE/PVDC/AL DIVIDED INTO SINGLE DOSES
049469137 - "100 MG GASTRO-RESISTANT TABLETS" 60 TABLETS IN BOTTLE
HDPE
13. BATCH NUMBER
Batch
14. SUPPLY CONDITION
15. INSTRUCTIONS FOR USE
16. BRAILLE INFORMATION
Posaconazole Zentiva 100 mg gastro-resistant tablets
17. UNIQUE IDENTIFIER – TWO-DIMENSIONAL BARCODE
Secondary packaging
Two-dimensional barcode including unique identifier.
18. UNIQUE IDENTIFIER – READABLE DATA
PC
SN
NN
Blue Box
Generic medicinal product
Price: Euro xxx
Optical stamp
May impair the ability to drive vehicles and operate machinery.
To be sold only upon presentation of a medical prescription valid for a single use, issued by hospital centres or specialists: internist, infectiologist, haematologist
MINIMUM INFORMATION TO BE INDICATED ON BLISTER OR STRIP
BLISTER
1. NAME OF THE MEDICINAL PRODUCT
Posaconazole Zentiva 100 mg gastro-resistant tablets
2. NAME OF THE MARKETING AUTHORISATION HOLDER
COMMERCIO
Zentiva Italia S.r.l.
3. EXPIRY DATE
Exp:
4. LOT NUMBER
Lot
5. OTHER
MINIMUM INFORMATION TO BE INDICATED ON BLISTER OR STRIP
BLISTER for unit doses
1. NAME OF THE MEDICINAL PRODUCT
Posaconazole Zentiva 00 mg
2. NAME OF THE MARKETING AUTHORISATION HOLDER
COMMERCIALISATION
Zentiva Italia S.r.l.
3. EXPIRY DATE
Expired
4. LOT NUMBER
Lot