2 years for the dropper container with white screw cap and tamper evident ring
After first opening of container: 4 weeks (for both dropper containers)
6.4 Special precautions for storage
store in a refrigerator (2°C – 8°C).
Keep the bottle in the outer carton in order to protect from light.
After first opening the bottle: do not store above 25°C and use within four weeks.
6.5 Nature and contents of container
Dropper container (5 ml) of polyethylene with either a screw cap and tamper evident overcap of polyethylene or with a screw cap and tamper-evident ring
Each dropper container contains 2.5 ml eye drops solution corresponding to approximately 80 drops of solution.
Pack sizes: 1 x 2.5 ml, 3 x 2.5 ml, 6 x 2.5 ml.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
No special requirements.
7. MARKETING AUTHORISATION HOLDER
Pharmacia Ireland
9 Riverwalk
National Digital Park
Citywest Business Campus
Dublin 24
Ireland
8. MARKETING AUTHORISATION NUMBER(S)
PA 936/41/1
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorization: 25th July 1997
Date of last renewal: 16th December 2006
10. DATE OF REVISION OF THE TEXT
6th October 2011
XN 12_0
|