Summary of Product Characteristics
last updated on the eMC:
20/01/2011
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 20/01/2011 and displayed until Current
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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 4.1 - Therapeutic indications
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Change to section 4.2 - Posology and method of administration
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Change to section 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.6 - Pregnancy and Lactation
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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 4.9 - Overdose
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 6.1 - List of Excipients
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Change to section 6. 6 - Instructions for use, handling and disposal
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| Date of revision of text on the SPC: 01-Dec-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 2 – minor change.
Section 3 – minor change.
Section 4.1 – minor wording change.
Section 4.2 – changes to posology, administration and patient population.
Section 4.3 – Additional wording.
Section 4.4 – minor changes.
Section 4.6 – minor template changes.
Section 4.7 – additional warning.
Section 4.8 – Section reformatted and uses MeDRA terms.
Section 4.9 – Addition information added.
Section 5.1 – Therapeutic group updated, template updates and a waiver has been added.
Section 5.2 – minor template change.
Section 6.1 – minor descriptive changes made to excipients.
Section 6.6 – minor template changes and some re-wording
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Updated on 06/09/2010 and displayed until 20/01/2011
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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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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| Update Section 6.3 of the SmPC - Shelf life change from 18 months to 36 months
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Updated on 29/10/2008 and displayed until 06/09/2010
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Reasons for adding or updating:
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Change to section 10 date of revision of the text
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Removal of Black Triangle
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| Date of revision of text on the SPC: 01-Oct-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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- Black triangle removed
- 'Date of revision' updated
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Updated on 25/01/2008 and displayed until 29/10/2008
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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 8 - MARKETING AUTHORISATION NUMBER(S)
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 12/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 4.2: Update to the administration information, ie
After 2 consecutive injections of Macugen, if a patient does not demonstrate a treatment benefit (loss of less than 15 letters of visual acuity) at the 12-week visit, consideration should be given to stopping or withholding Macugen therapy.
Section 8 – (as per Luer Lok approval)
New EU number, ie EU/1/05/325/002
Section 10 - (as per Luer Lok approval)
Date update (ie December 2007)
Information update
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Updated on 10/05/2007 and displayed until 25/01/2008
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Reasons for adding or updating:
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 04/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 5.1 Pharmacotherapeutic Group: Ocular Vascular Disorder Agent, ATC Code: S01LA03
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Updated on 22/05/2006 and displayed until 10/05/2007
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Reasons for adding or updating:
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