Summary of Product Characteristics
last updated on the eMC:
05/03/2009
When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.
Updated on 05/03/2009 and displayed until Current
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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: 02-Feb-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.8 - Under heading cardiac disorders - 'Uncommon - arrhythmia' added
Under heading Eye disorders in Uncommon - 'corneal erosion, keratitis' added
Under heading Skin and tissue disorders - 'Uncommon - dermatitis contact' added and 'Not known - rash, alopecia' added
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Updated on 04/09/2008 and displayed until 05/03/2009
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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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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| Date of revision of text on the SPC: 31-Jul-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4 (Special warnings and precautions) has been updated to include information on absorption through the skin, including caution for pregnant women or women attempting to become pregnant coming into contact with the bottle contents. Additionally, information has been included in this section on known problems associated with prolonged use of BAC.
Section 4.6 (Pregnancy and lactation) has been updated to state that travoprost has harmful effects on pregnancy and/or foetus/new-born children.
Section 4.8 (Undesirable effects) Included is the adverse reactions listed were observed in clinical studies and post marketing experience. The adverse reactions have been put into a table.
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Updated on 11/05/2006 and displayed until 04/09/2008
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Reasons for adding or updating:
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