Aranesp PFS

  • Name:

    Aranesp PFS

  • Company:
    info
  • Active Ingredients:

    Darbepoetin alfa

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 03/08/18

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Summary of Product Characteristics last updated on medicines.ie: 17/10/2017
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Amgen Ltd

Amgen Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name AMGEVITA prefilled pen Active Ingredients adalimumab
Medicine Name AMGEVITA prefilled syringe Active Ingredients adalimumab
Medicine Name Aranesp PFS Active Ingredients Darbepoetin alfa
Medicine Name ARANESP PFS with needle guard Active Ingredients Darbepoetin alfa
Medicine Name Aranesp SureClick Active Ingredients Darbepoetin alfa
Medicine Name Blincyto Active Ingredients Blinatumomab
Medicine Name Imlygic Active Ingredients Talimogene laherparepvec
Medicine Name KANJINTI Active Ingredients Trastuzumab
Medicine Name Kyprolis Active Ingredients Carfilzomib
Medicine Name Mimpara Granules Active Ingredients cinacalcet hydrochloride
Medicine Name Mimpara tablets Active Ingredients cinacalcet hydrochloride
Medicine Name Neulasta On Body Injector Active Ingredients Pegfilgrastim
Medicine Name Neulasta Pre-Filled Syringe Active Ingredients Pegfilgrastim
Medicine Name Neupogen 30 MU (0.3 mg/ml) solution for injection Active Ingredients Filgrastim
Medicine Name Neupogen Singleject 30 MU (0.6 mg/ml) Active Ingredients Filgrastim
Medicine Name Neupogen Singleject 48 MU (0.96 mg/ml) Active Ingredients Filgrastim
Medicine Name Nplate Active Ingredients Romiplostim
Medicine Name Parsabiv Active Ingredients etelcalcetide
Medicine Name Prolia Active Ingredients Denosumab
Medicine Name Repatha SureClick Active Ingredients Evolocumab
Medicine Name Vectibix Active Ingredients Panitumumab
Medicine Name XGEVA Active Ingredients Denosumab
1 - 0 of 22 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 3 August 2018

Updated on 17 October 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 17 October 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 17 October 2017 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

information update to administration in section 4.2
Update with new AEs in Section 4.8
Date of revision changed to September 2017

Updated on 17 October 2017 PIL

Reasons for updating

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

Updated on 1 September 2017 SmPC

Reasons for 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

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

Free text change information supplied by the pharmaceutical company

Section 4.4 Addition of severe cutaneous adverse reactions
Section 4.8 Addition of severe cutaneous adverse reactions
Section 10 date of revision updated to August 2017

Updated on 1 September 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 10 April 2017 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 5 October 2015 SmPC

Reasons for 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 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

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 Language around utilisation of lowest possible dose has been strengthened

Section 4.4 Text added around investigation of causes for non-responders

Section 5.1 Addition of result from post-hoc analysis data

Section 10 Date of revision of the text updated to September 2015

Updated on 5 October 2015 PIL

Reasons for updating

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

Updated on 30 July 2015 PIL

Reasons for updating

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

Updated on 30 July 2015 SmPC

Reasons for updating

  • Addition of joint SPC covering all presentations

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 14 August 2013 PIL

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration

Updated on 5 March 2013 PIL

Reasons for updating

  • Change to date of revision
  • Addition of manufacturer

Updated on 14 December 2011 PIL

Reasons for updating

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

Updated on 29 March 2011 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to storage instructions
  • Change to drug interactions
  • Change to information about driving or using machinery
  • Change to further information section
  • Change to date of revision

Updated on 7 February 2011 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 9 September 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

Updated on 7 May 2010 PIL

Reasons for updating

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

Updated on 22 December 2009 PIL

Reasons for updating

  • Change to instructions about overdose
  • Change to side-effects
  • Change to date of revision

Updated on 4 December 2008 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 30 October 2008 PIL

Reasons for updating

  • Change to side-effects

Updated on 19 March 2008 PIL

Reasons for updating

  • Improved electronic presentation
  • Change to side-effects
  • Change to dosage and administration

Updated on 6 November 2007 PIL

Reasons for updating

  • Changes to therapeutic indications

Updated on 26 July 2007 PIL

Reasons for updating

  • Introduction of new strength

Updated on 19 January 2007 PIL

Reasons for updating

  • Change to dosage and administration

Updated on 17 January 2007 PIL

Reasons for updating

  • Change to dosage and administration
  • Change to date of revision

Updated on 14 June 2006 PIL

Reasons for updating

  • Improved electronic presentation
  • Change to date of revision

Updated on 22 March 2006 PIL

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration

Updated on 21 November 2005 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 27 July 2005 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 5 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie