Updated on 05/01/2012 and displayed until Current
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Reasons for adding or updating:
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-
Change to section 4.2 - Posology and method of administration
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Change to section 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.8 - Undesirable Effects
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Change to section 6. 4 - Special Precautions for Storage
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| Date of revision of text on the SPC: 01-Nov-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Changes to Sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.8 and 6.4.
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Updated on 20/06/2011 and displayed until 05/01/2012
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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Change to section 2 - Qualitative and quantitative composition
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 01-Jun-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Minor changes to Sections 1, 2 and 4.6.
Changes to Sections 4.4 and 4.8.
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Updated on 16/03/2011 and displayed until 20/06/2011
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Reasons for adding or updating:
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Correction of spelling/typing errors
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| Date of revision of text on the SPC: 01-Mar-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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Updated on 22/11/2010 and displayed until 16/03/2011
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Reasons for adding or updating:
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-
Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 01-Sep-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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SmPC: Changes to Sections 4.8
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Updated on 30/06/2010 and displayed until 22/11/2010
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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| Date of revision of text on the SPC: 01-Jun-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change to section 4.4: Special warnings and precautions for use.
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Updated on 03/12/2007 and displayed until 30/06/2010
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Reasons for adding or updating:
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-
Change to section 4.2 - Posology and method of administration
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 11/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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- XM_027
Section 4.2 & 4.4 - Update to contact lens wording for consistency with Xalatan label (MHRA request at renewal)
- XM_028
Section 4.8 - Removal of ADRs (SLE & Peyronie's disease) for timolol
(BfArM request at renewal)
- XM_029
Section 4.8 - Add palpitations as ADR for latanoprost
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Updated on 02/07/2007 and displayed until 03/12/2007
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Reasons for adding or updating:
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-
Change to section 4.1 - Therapeutic indications
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| Date of revision of text on the SPC: 06/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.1 To extend the indication by including treatment following therapy with prostaglandin analogues
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Updated on 03/04/2007 and displayed until 02/07/2007
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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Change to section 3 - Pharmaceutical form
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Change to section 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 4.8 - Undesirable Effects
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 6. 5 - Nature and Contents of Container
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| Date of revision of text on the SPC: 02/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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|
2 – Reformatting
3 – Reformatting
4.3 – Reformatting
4.4 – Rewording of the warning concerning Beta-blockers and hypoglycaemia.
4.5 – Interactions with concomitant ophthalmic administrations of two prostaglandin analogues. Also interactions concerning concomitant treatment with oral beta-adrenergic blocking agent.
4.7 – Wording inserted that patients should not drive or use machines due to transient blurring of vision.
4.8 – Includes new adverse events.
6.4 – Reformatting.
6.5 – Reformatting.
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Updated on 23/02/2006 and displayed until 03/04/2007
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Reasons for adding or updating:
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-
Removal of Black Triangle
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Updated on 28/10/2005 and displayed until 23/02/2006
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Reasons for adding or updating:
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Change to section 4.2 - Posology and Method of Administration
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 10 (date of (partial) revision of the text
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Updated on 20/05/2005 and displayed until 28/10/2005
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Reasons for adding or updating:
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-
Change to section 4.8 - Undesirable Effects
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Updated on 18/11/2004 and displayed until 20/05/2005
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Reasons for adding or updating:
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-
Change to section 6. 5 - Nature and Contents of Container
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Change to section 7 - Marketing Authorisation Holder
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Change to section 10 (date of (partial) revision of the text
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Updated on 16/11/2004 and displayed until 18/11/2004
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Reasons for adding or updating:
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-
Change to section 6. 5 - Nature and Contents of Container
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Change to section 7 - Marketing Authorisation Holder
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Pending awaiting re-submission
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Updated on 16/10/2001 and displayed until 16/11/2004
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Reasons for adding or updating:
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