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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: 29/09/2011
SPC Enbrel 10 mg powder and solvent for solution for injection for paediatric use

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 29/09/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
Date of revision of text on the SPC:   24-Aug-2011
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
Section 4.1:    Extension of polyarticular JIA population to include 2 & 3 year olds. Extension of paediatric psoriasis to include 6 & 7 year olds.
Section 4.2:    Update to paediatric population information.
Section 5.1:    Update to Clinical efficacy and safety information. Update to paediatric population information.
Section 6.3:     Update to shelf life information
Section 6.4:     Update to storage information
Updated on 25/08/2011 and displayed until 29/09/2011
Reasons for adding or updating:
  • New SPC for medicines.ie
Date of revision of text on the SPC:  
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
None provided

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Active Ingredients

 
  Etanercept