Enbrel 50 mg solution for injection in pre-filled pen

  • Name:

    Enbrel 50 mg solution for injection in pre-filled pen

  • Company:
    info
  • Active Ingredients:

    Etanercept

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 26/11/19

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Summary of Product Characteristics last updated on medicines.ie: 26/11/2019

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Pfizer Healthcare Ireland

Pfizer Healthcare Ireland

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Medicine Name Accupro 10 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 20 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 40 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 5 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accuretic 20 mg/12.5 mg Tablets Active Ingredients Hydrochlorothiazide, Quinapril hydrochloride
Medicine Name Aciclovir 25 mg/ml Concentrate for Solution for Infusion. Active Ingredients Aciclovir sodium
Medicine Name Aldactone 100mg film coated tablets Active Ingredients Spironolactone
Medicine Name Aldactone 25mg film-coated tablets Active Ingredients Spironolactone
Medicine Name Aldactone 50 mg Film-coated tablets. Active Ingredients Spironolactone
Medicine Name Amlodipine Pfizer 10 mg Tablets Active Ingredients Amlodipine besilate
Medicine Name Amlodipine Pfizer 5 mg Tablets Active Ingredients Amlodipine besilate
Medicine Name Anugesic HC Cream Active Ingredients Balsam Peru, Benzyl Benzoate, Bismuth Oxide, Hydrocortisone Acetate, Pramocaine Hydrochloride, Zinc Oxide
Medicine Name ARICEPT 10 mg film coated tablets Active Ingredients Donepezil Hydrochloride
Medicine Name ARICEPT 5 mg film coated tablets Active Ingredients Donepezil Hydrochloride
Medicine Name Aromasin 25 mg coated tablets Active Ingredients Exemestane
Medicine Name Arthrotec 50 Active Ingredients Diclofenac Sodium, Misoprostol
Medicine Name Arthrotec 75 modified-release tablets Active Ingredients Diclofenac Sodium, Misoprostol
Medicine Name Ativan 1mg Tablets Active Ingredients Lorazepam
Medicine Name ATIVAN INJECTION Active Ingredients Lorazepam
Medicine Name BeneFIX Active Ingredients nonacog alfa
Medicine Name BESPONSA 1 mg powder for concentrate for solution for infusion Active Ingredients Inotuzumab ozogamicin
Medicine Name Bosulif 100 mg, 400 mg & 500 mg film-coated tablets Active Ingredients Bosutinib monohydrate
Medicine Name Cabaser 1mg Tablet Active Ingredients Cabergoline
Medicine Name Cabaser 2mg Tablet Active Ingredients Cabergoline
Medicine Name CAMPTO 20 mg/ml, concentrate for solution for infusion Active Ingredients Irinotecan hydrochloride trihydrate
1 - 0 of 227 items.Total: Infinity pages

When a pharmaceutical company changes any document, 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 26 November 2019 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: Section 4.8 Addition of adverse reaction for Inflammatory bowel disease. Package Leaflet:

Updated on 26 November 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 23 April 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 23 April 2019 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: Section 4.8 addition of PRAC class labelling for Lichenoid Reactions

Updated on 4 April 2019 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: Section 4.6 addition of most up-to-date information on the safe and effective use of etanercept during pregnancy.

Updated on 12 March 2019 PIL

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision

Updated on 3 August 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 3 August 2018 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: Section 7 Name and address of MAH changed from Pfizer UK to Pfizer Belgium.

Updated on 11 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: Date of approval, PfLEET number and internal revision number only

Updated on 10 May 2018 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 5 April 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 5 April 2018 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 26 February 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 26 February 2018 PIL

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation number

Updated on 5 February 2018 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 5 December 2017 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 7 June 2017 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 24 April 2017 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 4 May 2016 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 7 March 2016 PIL

Reasons for updating

  • Correction of spelling/typing errors
  • Improved electronic presentation

Updated on 28 January 2016 PIL

Reasons for updating

  • Change to dosage and administration

Updated on 18 December 2015 PIL

Reasons for updating

  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 22 October 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability

Updated on 26 June 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 4 August 2014 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to side-effects
  • Change to date of revision

Updated on 23 October 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 23 August 2013 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 28 June 2013 PIL

Reasons for updating

  • Change to storage instructions
  • Change to side-effects
  • Change to date of revision
  • Change to appearance of the medicine
  • Change to MA holder contact details
  • Change to improve clarity and readability

Updated on 27 March 2013 PIL

Reasons for updating

  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 17 January 2013 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 7 August 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Change to dosage and administration
  • Changes to therapeutic indications

Updated on 13 January 2012 PIL

Reasons for updating

  • Change to packaging

Updated on 21 October 2011 PIL

Reasons for updating

  • Change to storage instructions

Updated on 11 October 2011 PIL

Reasons for updating

  • Change to packaging
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Change due to user-testing of patient information

Updated on 23 September 2011 PIL

Reasons for updating

  • Changes to therapeutic indications

Updated on 23 August 2011 PIL

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 22 July 2011 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 10 June 2011 PIL

Reasons for updating

  • Change to side-effects

Updated on 31 May 2011 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 8 March 2011 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 4 February 2011 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change to dosage and administration

Updated on 16 December 2010 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 30 July 2010 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to further information section
  • Change to date of revision
  • Correction of spelling/typing errors

Updated on 5 July 2010 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change to MA holder contact details

Updated on 18 January 2010 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to MA holder contact details

Updated on 2 November 2009 PIL

Reasons for updating

  • PIL re-instated

Updated on 5 August 2009 PIL

Reasons for updating

  • New PIL for new product
  • PIL retired pending re-submission