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Pfizer Limited
Ramsgate Road, Sandwich, Kent, CT13 9NJ
Telephone: +44 (0)1304 616 161
Fax: +44 (0)1304 656 221

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 20/01/2011
SPC Macugen 0.3 mg solution for injection

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
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 6 - Instructions for use, handling and disposal
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
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
Updated on 06/09/2010 and displayed until 20/01/2011
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
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
Update Section 6.3 of the SmPC - Shelf life change from 18 months to 36 months
Updated on 29/10/2008 and displayed until 06/09/2010
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Removal of Black Triangle
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
- Black triangle removed
- 'Date of revision' updated
Updated on 25/01/2008 and displayed until 29/10/2008
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 10 date of revision of the text
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

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
Updated on 10/05/2007 and displayed until 25/01/2008
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
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
 
Section 5.1 Pharmacotherapeutic Group: Ocular Vascular Disorder Agent, ATC Code: S01LA03
Updated on 22/05/2006 and displayed until 10/05/2007
Reasons for adding or updating:
  • New SPC for new product

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