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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: 18/01/2012
SPC Enbrel 50 mg solution for injection in pre-filled pen

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 18/01/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   28-Nov-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Enbrel 50mg solution for injection in pre-filled pen – reduction in the number of medi-swabs supplied in pack (section 6.5)
Updated on 25/10/2011 and displayed until 18/01/2012
Reasons for adding or updating:
  • 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 medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Changes to section 6.4 - Update to allow storage outside of a refrigerator for 4 weeks
Updated on 29/09/2011 and displayed until 25/10/2011
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 medical prescription which may not be renewed (A)

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 26/08/2011 and displayed until 29/09/2011
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   05-Aug-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Section 7 Marketing Authorisation Holder now shows Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
Updated on 26/07/2011 and displayed until 26/08/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   29-Jun-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company


Section 4.8 has been updated to add systemic vasculitis as a rare side-effect.
Updated on 10/06/2011 and displayed until 26/07/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   27-May-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Section 4.8 of the SPC: Autoimmune hepatitis has been added as a rare undesirable effect under Hepatobiliary disorders
Updated on 01/06/2011 and displayed until 10/06/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   13-May-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Section 4.8 of SPC: Sarcoidosis has been added as a rare undesirable effect under Nervous system disorders.
Updated on 10/03/2011 and displayed until 01/06/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   21-Feb-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Section 4.8 of the SmPC has been updated as follows:
The introduction to the section has been completely revised to bring it more in line with the SPC guideline, highlighting the most common and the most serious AEs, providing the new prescriber with a succinct summary of the AE profile.
The system organ classification (SOC) has been re-ordered, consistent with the SPC guideline
The subsection to the table entitled ‘Serious adverse events reported in clinical trials’ has been deleted. 
Updated on 15/02/2011 and displayed until 10/03/2011
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   21-Jan-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Section 4.2: Inclusion of “The recommended dose is” under Paediatric populations
Further explanation of dosing in Paediatric populations (in pre-filled syringe and pre-filled pen presentations only)
Section 4.4: Warning of IBD in JIA patients
Section 4.8: Explanation of reports of IBD in JIA patients
Updated on 21/12/2010 and displayed until 15/02/2011
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 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC:   26-Nov-2010
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
SmPC
4.4: Updates regarding melanoma, merkel cell carcinoma & demyelination
Addition of precaution on use in Elderley (65 yrs and older)
4.8: Addition of melanoma, merkel cell carcinoma
6.3: Increase in shelf life from 2 years to 30 months (PFP & PFS SmPCs only)
(6.6: An error was found in Section 6.6 of the Enbrel 25mg/ml powder and solvent for solution for injection for paediatric use SPC, therefore it has been corrected here)
Updated on 06/08/2010 and displayed until 21/12/2010
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 10 - Date of revision of the text
Date of revision of text on the SPC:   06-Jul-2010
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Type II variation (EMEA/H/C/262/II/117). Update of section 4.4 and 4.8 of the SPC with information regarding Paediatric Malignancies and Leukaemia. The Patient Information Leaflet is updated accordingly.
Updated on 05/07/2010 and displayed until 06/08/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   05-May-2010
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Update of section 4.4 of the SmPC with information regarding reports of hypoglycaemia following initiation of Enbrel in patients receiving medication for diabetes. The Patient Information Leaflet is updated accordingly.
Updated on 07/01/2010 and displayed until 05/07/2010
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • 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 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Dec-2009
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company


Section 3: Pharmaceutical form expanded

Section 4.2: Updated with “Enbrel is administered by subcutaneous injection”

Section 4.4: Updated with “The safety and efficacy of Enbrel in patients with chronic infections have not been evaluated.” In the infections information

Section 4.4: Updated with “Enbrel should be used with caution in patients with a history of hepatitis C.” in the Hepatitis C information

Section 4.4: Updated with “The use of Enbrel in combination with other systemic therapies or phototherapy for the treatment of psoriasis has not been studied.” in the Combination Therapy information

Section 4.5: Updated with “Physicians should use caution when considering combination therapy with sulfasalazine.” in the Concurrent treatment with sulfasalazine information

Section 4.8: addition of “† Please see sub-section ‘Undesirable effects in paediatric patients with polyarticular juvenile idiopathic arthritis’ above.” In General disorders and administration site conditions information

Section 4.8: Update to information in Concurrent treatment with anakinra information.

Section 5.1: Update to description of Pharmacotherapeutic group

Section 5.2: Expansion of abbreviation - Enzyme-Linked Immunosorbent Assay (ELISA)

Section 6.1: Addition of E number for Mannitol

Section 6.3: Addition of information on in use shelf life

Section 6.6: Addition of “Any unused product or waste material should be disposed of in accordance with local requirements.”

Section 9: Update to date of last renewal
Updated on 30/10/2009 and displayed until 07/01/2010
Reasons for adding or updating:
  • SPC re-instated
Date of revision of text on the SPC:   16-Jul-2009
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
New SPC for new presentation of Enbrel
Updated on 04/08/2009 and displayed until 30/10/2009
Reasons for adding or updating:
  • New SPC for new product
  • SPC retired pending re-submission
Date of revision of text on the SPC:  
Legal Category:   Product subject to medical prescription which may not be renewed (A)

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

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Active Ingredients

 
  Etanercept