PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON
1 NAME OF MEDICINAL PRODUCT
Vyndaqel 20 mg soft capsules tafamidis meglumine
2 STATEMENT OF ACTIVE SUBSTANCES
Each soft capsule contains 20mg tafamidis meglumine equivalent to 12.2 mg tafamidis
3 LIST OF EXCIPIENTS
The capsule contains sorbitol (E420). See leaflet for further information
4 PHARMACEUTICAL FORM AND CONTENTS
30 soft capsules
90 soft capsules
5 METHOD AND ROUTE(S) OF ADMINISTRATION
Read the package leaflet before use.
Oral use
Lift here
6.SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF SIGHTAND 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
Do not store above 25°C
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
Pfizer Limited
Ramsgate Road
Sandwich, Kent
CT13 9NJ
United Kingdom
12.MARKETING AUTHORISATION NUMBER(S)
EU/1/11/717/001
EU/1/11/717/002
13.BATCH NUMBER
Lot
14.GENERAL CLASSIFICATION FOR SUPPLY
15.INSTRUCTIONS ON USE
16.INFORMATION IN BRAILLE
Vyndaqel
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Heat sealed blister card of 30 x 20 mg Vyndaqel soft capsules
1 NAME OF MEDICINAL PRODUCT
Vyndaqel 20 mg soft capsules
Tafamidis meglumine
2 NAME OF THE MARKETING AUTHORISATION HOLDER
Pfizer Limited (as MA Holder logo)
3 EXPIRY DATE
EXP
4 BATCH NUMBER
Lot
5 OTHER
To remove capsule push through from this side
Fold and reclose after removing capsule
Pull here |
