Glybera (alipogene tiparvovec)–Labelling - C10 AX10
1.NAME OF THE MEDICINAL PRODUCT
Glybera 3 × 1012 genome copies/ml solution for injection Alipogene tiparvovec
2.STATEMENT OF ACTIVE SUBSTANCE
Each vial contains 1 extractable ml of solution containing 3 × 1012 genome copies (gc) of alipogene tiparvovec.
3.LIST OF EXCIPIENTS
Potassium chloride Potassium dihydrogen phosphate Sodium chloride Disodium phosphate Sucrose Water for injections See package leaflet for further information
4.PHARMACEUTICAL FORM AND CONTENTS
Solution for injection
Patient-specific pack containing sufficient amount of vials to dose each patient Liquid absorbing sheet is also contained
5.METHOD AND ROUTE OF ADMINISTRATION
Intramuscular use.
Read the package leaflet before 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
Shelf life after first opening in the syringes: 8 hours (if space permitted)
9.SPECIAL STORAGE CONDITIONS
Store and transport vial frozen at -25°C to -15°C.
Keep the vial in the outer carton in order protect from light
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
This medicine contains genetically modified organisms.
Unused medicine must be disposed of in compliance with the local rules for genetically modified organisms.
11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
uniQure biopharma B.V.
Meibergdreef 61, 1105 BA Amsterdam, The Netherlands.
12.MARKETING AUTHORISATION NUMBER
EU/1/12/791/001
13.BATCH NUMBER
Lot
14.GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15.INSTRUCTIONS ON USE
16.INFORMATION IN BRAILLE
Justification for not including Braille accepted.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TRANSPARENT SEALED PLASTIC CASING LABEL (2 vial pack)
1. NAME OF THE MEDICINAL PRODUCT
Glybera 3 × 1012 genome copies/ml solution for injection Alipogene tiparvovec
2.NAME OF THE MARKETING AUTHORISATION HOLDER
uniQure biopharma B.V
3.EXPIRY DATE
EXP
4.BATCH NUMBER
Lot
5.OTHER
Intramuscular use
Read the package leaflet before use.
Store frozen at -25°C to -15°C.
This product contains genetically modified organisms.
Pack size 2 vials
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TRANSPARENT SEALED PLASTIC CASING LABEL (3 vial pack)
1. NAME OF THE MEDICINAL PRODUCT
Glybera 3 × 1012 genome copies/ml solution for injection
Alipogene tiparvovec
2. NAME OF THE MARKETING AUTHORISATION HOLDER
uniQure biopharma B.V
3. EXPIRY DATE
EXP
4. BATCH NUMBER
Lot
5. OTHER
Intramuscular use
Read the package leaflet before use.
Store frozen at -25°C to -15°C.
This product contains genetically modified organisms.
Pack size 3 vials
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
VIAL LABEL
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION
Glybera 3 × 1012 genome copies/ml solution for injection
Alipogene tiparvovec
Intramuscular 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
1 ml
6.OTHER
Store |
