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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: 13/04/2012
SPC Caverject 5mcg, 10mcg & 20mcg Powder and Solvent for 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 13/04/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
Date of revision of text on the SPC:   01-Oct-2011
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
2 – administrative update
4.4 – addition of benzyl alcohol warning, deletion of lactose warning
6.1 – updated (excipients unchanged)
6.6 – additional detail added: Do not use if the solution appears cloudy or contains particles. Discard any unused material.
9 – update to date of last Renewal

Updated on 24/10/2011 and displayed until 13/04/2012
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Oct-2011
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
SmPC changes to section 7 - MA Holder’s name change and Section 10 – revision date.
Updated on 29/09/2009 and displayed until 24/10/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   01-Sep-2009
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company


Update to section 4.4. to include a warning on lactose intolerance.

Revision of section 4.8 to medra terminology

Update to section 5.1 to include the ATC code and therapeutic group.
Updated on 19/08/2008 and displayed until 29/09/2009
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Alprostadil