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Pfizer Healthcare Ireland
9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24,
Telephone: +353 1 467 6500
Fax: +353 1 467 6501
Medical Information Direct Line: 1 800 633 363
Summary of Product Characteristics last updated on medicines.ie: 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 medicines.ie. For each version, we show the dates it was published on medicines.ie 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 - Special precautions for disposal and other handling
Date of revision of text on the SPC:   01-Dec-2010
Legal Category:   Product subject to restricted prescription (C)

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 07/09/2010 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:   Product subject to restricted prescription (C)

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 24/01/2008 and displayed until 07/09/2010
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   12/2007
Legal Category:   prescription only

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 14/05/2007 and displayed until 24/01/2008
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   04/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
 
 Section 5.1  Pharmacotherapeutic Group: Ocular Vascular Disorder Agent, ATC Code: S01LA03
Updated on 18/08/2006 and displayed until 14/05/2007
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 18/08/2006 and displayed until 18/08/2006
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 17/08/2006 and displayed until 18/08/2006
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 22/05/2006 and displayed until 17/08/2006
Reasons for adding or updating:
  • New SPC for new product

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Active Ingredients

 
  Pegaptanib sodium