Summary of Product Characteristics
last updated on the eMC:
23/07/2009
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 23/07/2009 and displayed until Current
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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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: 01-Jul-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 6.3: New bottle with new shelf life
Section 6.5: Information added on new container - closure system of cap.
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Updated on 23/07/2007 and displayed until 23/07/2009
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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 3 - Pharmaceutical form
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Change to section 4. Clinical Particulars
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Change to section 6.1 - List of Excipients
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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: 07/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 1 Re-wording/update
Section 2 Update
Section 3 Update
Section 4.4 Update on information wrt the use of Xalatan in aphakic patients, in pseudophakic patients with torn posterior lens capsule or anterior chamber lenses, or in patients with known risk factors for cystoid macular oedema AND Update of information on asthma
Section 4.5 Update regarding concomitant ophthalmic administration of prostaglandin analogues or derivatives.
Section 4.8 Reformatting
Section 6.1 Re-wording
Section 6.4 Re-wording
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Updated on 04/04/2007 and displayed until 23/07/2007
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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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Change to section 4.8 - Undesirable Effects
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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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4.4 – Information regarding the change in eye colour. May change eyelashes and vellus hair in treated eye or the surrounding area.
4.8 – Update of the section to include new adverse events including palpitation.
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Updated on 26/09/2006 and displayed until 04/04/2007
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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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| Date of revision of text on the SPC: 09/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.2 (Poslogy and method of administration): Instruction on use of contact lenses added
Section 4.3 (Contraindications): Removal of contact lens contraindication
Section 4.4 (Warnings and precautions for use): benzalkonium chloride warning
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Updated on 13/05/2005 and displayed until 26/09/2006
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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 21/10/2004 and displayed until 13/05/2005
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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 27/09/2004 and displayed until 21/10/2004
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Updated on 01/03/2004 and displayed until 27/09/2004
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Reasons for adding or updating:
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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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Correction of spelling/typing errors
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Updated on 07/05/2002 and displayed until 01/03/2004
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 03/05/2002 and displayed until 07/05/2002
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Reasons for adding or updating:
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Change to section 1 - trade name
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Change to section 2 - qualitative and quantitative composition
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Change to section 4.1 - Therapeutic Indications
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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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Change to section 6.1 - List of Excipients
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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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Change to section 6. 6 - Instruction for Use/Handling
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Change to section 9 - Date of Renewal of Authorisation
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Change to section 10 (date of (partial) revision of the text
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