Last Updated on eMC 07-12-2017 View medicine  | Pfizer Limited Contact details

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.

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:01-12-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The SPC has been updated as follows:

Section 4.4 - Updated to update the frequency of reporting of peripheral demyelinating polyneuropathies.

Section 4.8 - ADRs have been tabulated and some ADRs frequencies have been updated and 3 additional ADRs (Leukaemia; Lymphoma; and Peripheral demyelinating events) are added. Information on 2 ADRs (Interstitial lung disease and Autoimmune hepatitis) for which there are notable differences observed in the frequencies between the etanercept only and etanercept plus concomitant methotrexate treatment groups is added.

Reasons for adding or updating:

  • Change to section 1 - Name of the medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:01-05-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Addition of 25mg Pre-filled Pen to the 50mg Pre-filled Pen SPC.  Updates to sections 1, 2, 4.2, 6.5, 8 & 10

Reasons for adding or updating:

  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:01-06-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 10 DATE OF REVISION OF THE TEXT has been updated to May 2017 for Enbrel 50mg pre-filled Pen. 

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:01-06-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Type II Variation update to Section 4.8 ‘Undesirable Effects’ of the SPC in order to change the frequency category of the ADR ‘elevated liver enzymes’ from ‘rare’ to ‘uncommon’ and to add some further details on the frequency of elevated liver enzymes reported with etanercept in double-blind controlled trials with or without concomitant methotrexate use. The Package Leaflet (Section 4) was updated accordingly.

In addition, Pfizer took the opportunity to update Section 4.4 of the SPC to add a statement on traceability of biological medicinal products as requested by the PRAC, to make a small correction in Section 6 of the 50 mg solution for injection in a pre-filled pen Package Leaflet ( EU / 1 / 99 / 126 / 0019-021), and to bring the PI in line with the latest QRD template version 10 (i.e. include the unique identifiers in sections 17 and 18 of Annex IIIA).

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:01-04-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Update to Section 4.8 ‘Undesirable Effects’ of the SPC in order to change the frequency category of the ADR ‘elevated liver enzymes’ from ‘rare’ to ‘uncommon’ and to add some further details on the frequency of elevated liver enzymes reported with etanercept in double-blind controlled trials with or without concomitant methotrexate use. The Package Leaflet (Section 4) was updated accordingly.

In addition, Pfizer took the opportunity to update Section 4.4 of the SPC to add a statement on traceability of biological medicinal products as requested by the PRAC, to make a small correction in Section 6 of the 50 mg solution for injection in a pre-filled pen Package Leaflet ( EU / 1 / 99 / 126 / 0019-021), and to bring the PI in line with the latest QRD template version 10

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:01-04-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The SPC has been updated as follows:

EU EN 043 is an update to Section 5.1 of the SmPC to add efficacy and safety information to reflect the final 2-year data from study B181031 (non-radiographic axial spondyloarthritis study).

EU EN 051 updates to Section 4.4 of the SmPC to include information on new onset congestive heart failure (CHF), including CHF in patients without known pre-existing cardiovascular disease, and Section 4.8 to amend the term ‘worsening of congestive heart failure’ to ‘congestive heart failure’

Reasons for adding or updating:

  • Change to section 4.6 - Fertility, pregnancy and lactation

Date of revision of text on the SPC:01-11-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The SPC has been updated as follows:

Section 4.6 of the SmPC and Section 2 of the PIL have been updated to include the information on the effects of etanercept on pregnancy to reflect the final report of the OTIS registry.

Reasons for adding or updating:

  • Change to section 5.1 - Pharmacodynamic properties

Date of revision of text on the SPC:01-03-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The SPC has been updated as follows: The  10-year efficacy data in rheumatoid arthritis (RA) has been added  in the clinical trials section 5.1 of the Summary of Product Characteristics (SmPC).

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects

Date of revision of text on the SPC:01-09-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Update section 4.8 SmPC to align with CDS to introduce viral infections in the list of opportunistic infections.

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 4.8 - Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:01-07-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Updates to sections

4.1, 4.2, 5.1 - Addition of axial spondyloarthritis

4.8 - All presentations have been updated to include the name change of the IMB to HPRA.

10 – date of revision

 

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration

Date of revision of text on the SPC:01-01-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Update to Section 4.2

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:01-10-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Update to Sections 4.4 & 4.8

Reasons for adding or updating:

  • Change to section 4.6 - Fertility, pregnancy and lactation

Date of revision of text on the SPC:01-07-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Update to section 4.6, Fertility, pregnancy and lactation to add information regarding the placental transfer of etanercept. Enhanced instructions for preparing for an injection using the pre-filled syringe presentations following the introduction of a new packaging design, referred to as a slim-pack design have been added. Minor changes to align with EMA Product Information (PI) QRD templates have also been introduced.

Reasons for adding or updating:

  • Change to section 6.6 - Special precautions for disposal and other handling

Date of revision of text on the SPC:01-05-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Update to the description of the liquid solution in the Enbrel pre-filled syringe (PFS) and pre-filled pen (PFP) presentations.

Reasons for adding or updating:

  • Change to section 4.6 - Fertility, pregnancy and lactation

Date of revision of text on the SPC:01-02-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.6 of the SPC has been updated regarding lactation information

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects

Date of revision of text on the SPC:03-12-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Update to section 4.8

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable Effects

Date of revision of text on the SPC:01-10-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Add scleritis as an adverse drug reaction to section 4.8 of the SPC

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:01-08-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Update to sections 4.4 & 4.8  to supplement the infections information in the special warnings and AE sections regarding listeria, legionella, and parasitic infection, including protozoal infections.

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 4.3 - Contraindications
  • 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 10 date of revision of the text

Date of revision of text on the SPC:01-07-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Sections 4.1 - 4.5, 4.8, 5.1, 5.2, 10: Extension the indication for juvenile idiopathic arthritis (JIA) to include three new subtypes of the disease and to include long-term safety information for the JIA population, together with reclassification of the licensed indication of polyarticular JIA into the International League of Associations for Rheumatology (ILAR) classification of polyarthritis (rheumatoid factor positive) and polyarthritis (rheumatoid factor negative). Furthermore, an additional etanercept dosage regimen of 0.8 mg/kg (up to a maximum of 50 mg per dose) once weekly is proposed in addition to the current approved JIA dosage of 0.4 mg/kg (up to a maximum of 25 mg per dose) twice weekly for the treatment of JIA

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:24-08-2011

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)

Reasons for adding or updating:

  • Change to section 6. 4 - Special Precautions for Storage

Date of revision of text on the SPC:24-08-2011

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

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:24-08-2011

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

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder

Date of revision of text on the SPC:05-08-2011

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

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable Effects

Date of revision of text on the SPC:29-06-2011

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

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable Effects

Date of revision of text on the SPC:27-05-2011

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

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable Effects

Date of revision of text on the SPC:13-05-2011

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.

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable Effects

Date of revision of text on the SPC:21-02-2011

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. 

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:21-01-2011

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

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:26-11-2010

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)

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:01-07-2010

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.

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for Use

Date of revision of text on the SPC:05-05-2010

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.

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:26-11-2009

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)

 

Reasons for adding or updating:

  • New SPC for new product

Date of revision of text on the SPC:01-01-0001

Legal Category:POM

Black Triangle (CHM): YES