Travatan 40 micrograms/ml eye drops solution
*Company:
Novartis Ireland LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 22 April 2022
File name
TRAVATAN 40 microgramsmL eye drops solution_PIL_29.09.2021_clean.pdf
Reasons for updating
- Change to name of manufacturer
Updated on 08 January 2020
File name
Travatan REG PIL 640836 IPHA .pdf
Reasons for updating
- Improved presentation of PIL
Updated on 29 August 2019
File name
Travatan REG_SPC PF18-0241combclean July 2018.pdf
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 25 March 2019
File name
IPHA_Travatan_640836_R92_TBI 6 FEB 2019.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 03 September 2018
File name
REG_SPC_TRAVATAN_PF18_0241combclean.pdf
Reasons for updating
- Change to section 5.3 - Preclinical safety data
- Change to section 6.4 - Special precautions for storage
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
EPA wording and QRD template updated
Updated on 04 July 2018
File name
REG_SPC_TRAVATAN_PF_0145.docx
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 13 June 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 13 June 2017
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 08 June 2017
File name
PIL_9075_232.pdf
Reasons for updating
- New PIL for new product
Updated on 08 June 2017
Reasons for updating
- Change to section 4 - possible side effects
Updated on 30 May 2017
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 19 May 2017
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 08 April 2015
Reasons for updating
- Improved electronic presentation
Updated on 12 February 2015
Reasons for updating
- Change to section 4.3 - Contraindications
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 11 February 2015
Reasons for updating
- Change of contraindications
Updated on 13 January 2015
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 09 January 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
Updated on 07 October 2014
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 03 October 2014
Reasons for updating
- Improved electronic presentation
Updated on 05 June 2014
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.2 - Added "After cap is removed, if the tamper evident snap collar is loose, remove before using the medicinal product." and "For patients who wear contact lenses, please refer to section 4.4."
Section 4.4 - Added "Periorbital and lid changes including deepening of the eyelid sulcus have also been observed with prostaglandin analogues.", "TRAVATAN should therefore be used with caution in patients with active intraocular inflammation." and "Macular oedema has been reported during treatment with prostaglandin F2a analogues."
Section 4.6 - Added fertility information
Section 4.7 - Added "TRAVATAN has no or negligible influence on the ability to drive and use machines, however..."
Section 4.8 - Section re-formatted and revised to update to adverse events and frequency. Added reporting information
Section 6.5 - Added "Each 4 mL bottle will contain 2.5 mL of solution."
Updated on 28 May 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 14 August 2013
Reasons for updating
- Improved electronic presentation
Updated on 16 July 2013
Reasons for updating
- Change to MA holder contact details
Updated on 30 May 2013
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 29 May 2013
Reasons for updating
- Change to marketing authorisation holder
Updated on 04 May 2011
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In the side effects listed under poluquaternium-1 preserved Travatan - 'eye irritation, foreign body sensation in eyes, conjunctival hyperaemia and eyelid pruritus' are removed, and 'ocular discomfort' is added.
In Section 10, Date of revision of the text, the date of revision is updated.
Updated on 09 December 2010
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
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.
Updated on 09 December 2010
Reasons for updating
- Change of inactive ingredient
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 20 March 2007
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 20 March 2007
Reasons for updating
- Improved electronic presentation
Updated on 18 May 2005
Reasons for updating
- Change to further information section
Updated on 28 October 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 13 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)