| In Section 2, Qualitative and quantitative composition, the excipient Benzalkonium Chloride has been replaced with ‘polyquaternium-1 (POLYQUAD) 10 microgram, propylene glycol 7.5 mg’
In Section 4.2, Posology and method of administration, ‘For Ocular use’ is moved under the sub-section ‘Method of Administration’
In Section 4.4, Special warnings and precautions for use, the warning related to Benzalkonium Chloride is replaced with the following text – ‘TRAVATAN contains propylene glycol which may cause skin irritation.’
In Section 4.8, Undesirable effects, additional information about polyquaternium-1-preserved Travatan is included.
In Section 5.1, Pharmacodynamic properties, additional information about polyquaternium-1-preserved Travatan is included.
In Section 6.1, Excipients, the list of excipients has been modified to remove ‘Benzalkonium Chloride, Trometamol and Disodium Edetate’ and add ‘Polyquaternium-1, Sodium Chloride and Propylene Glycol (E1520)’
In Section 6.3, Shelf Life, the shelf life has been changed from 3 Years to 2 Years.
In Section 9, Date of first authorisation/ Renewal of authorisation, the date of last renewal is corrected.
In Section 10, Date of revision of the text, the revision date is amended.
|
