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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: 16/01/2012
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 the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 16/01/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Removal of Black Triangle
Date of revision of text on the SPC:   24-Aug-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Enbrel 50mg solution for injection in pre-filled syringe – Removal of black triangle & reduction in the number of medi-swabs supplied in pack (section 6.5)
Updated on 24/10/2011 and displayed until 16/01/2012
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:   POM
Black Triangle (CHM):   YES

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 28/09/2011 and displayed until 24/10/2011
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:   POM
Black Triangle (CHM):   YES

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 31/08/2011 and displayed until 28/09/2011
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:   POM
Black Triangle (CHM):   YES

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 22/07/2011 and displayed until 31/08/2011
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:   POM
Black Triangle (CHM):   YES

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 13/06/2011 and displayed until 22/07/2011
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:   POM
Black Triangle (CHM):   YES

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 13/06/2011
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:   POM
Black Triangle (CHM):   YES

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:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
SmPC (Enbrel continues to be a black triangle ▼ product)
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 11/02/2011 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:   POM
Black Triangle (CHM):   YES

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 10/01/2011 and displayed until 11/02/2011
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
Date of revision of text on the SPC:   26-Nov-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
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)

Updated on 22/07/2010 and displayed until 10/01/2011
Reasons for adding or updating:
  • 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:   01-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Includes additional warnings in section 4.4 relating to reports of malignancies (including lymphoma) in children and leukaemia.  There is also the addition of leukaemia and lymphoma, as well as worsening of psoriasis as adverse reactions to the table in section 4.8 of the SPC.
Updated on 04/06/2010 and displayed until 22/07/2010
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:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.4 - Additional Text:

Hypoglycaemia in patients treated for diabetes

There have been reports of hypoglycaemia following initiation of Enbrel in patients receiving medication for diabetes, necessitating a reduction in anti-diabetic medication in some of these patients.
Updated on 21/12/2009 and displayed until 04/06/2010
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • 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
Date of revision of text on the SPC:   26-Nov-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Section 4.1: Addition text -
psoralen and ultraviolet-A light (PUVA)

Section 4.4: Additional text -
The safety and efficacy of Enbrel in patients with chronic infections have not been evaluated. 

Enbrel should be used with caution in patients with a history of hepatitis C.

The use of Enbrel in combination with other systemic therapies or phototherapy for the treatment of psoriasis has not been studied.

 


Section 4.5: Additional text -

Physicians should use caution when considering combination therapy with sulfasalazine.


Section 4.8:  (Undesirable Effects)

Uveitis and Worsening of congestive heart failure have been added.

Section 5.1: Addition of Immunosuppressants to the Pharmacotherapeutic group

Secrtion 5.2: Additional text –

Enzyme-Linked Immunosorbent Assay (ELISA)

 
Updated on 30/07/2009 and displayed until 21/12/2009
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   YES

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

Active Ingredients/Generics

 
  etanercept