AVONEX 30 micrograms/0.5ml solution for injection, in pre-filled pen *

  • Company:

    Biogen Idec Ltd
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

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 25 February 2021

File name

Avonex PEN_PIL_Feb 2021_IE_1614288805.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 19 January 2021

File name

Avonex PEN_PIL_UK & IRL_12_2020_1611097036.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 20 September 2019

File name

Avonex PEN_SmPC_UK&Ireland_Sept 2019_1569001177.pdf

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • 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 4.3: Removal of contraindication related to pregnancy

Section 4.4: Inclusion of statement regarding batch traceability

Section 4.6: Updated guidance on pregnancy and breastfeeding following closure of INF pregnancy registry.

Updated on 20 September 2019

File name

Avonex PEN_PIL_UK&Ireland_Sept 2019_1569001101.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Removal of contraindication related to pregnancy, Inclusion of statement regarding batch traceability, Updated guidance on pregnancy and breastfeeding.

Updated on 08 April 2019

File name

Avonex PEN_PIL_UK&Ireland_Aug 2018_1554733486.pdf

Reasons for updating

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

Updated on 08 April 2019

File name

Avonex PEN_SmPC_UK&Ireland_Aug 2018_1554718653.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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

MAH transfer to Biogen Netherlands B.V.

Updated on 26 June 2017

Reasons for updating

  • New SPC for new product

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

Updated on 26 June 2017

Reasons for updating

  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

Minor editorial changes associated with QRD v10 only.

Updated on 14 June 2017

File name

PIL_15033_952.pdf

Reasons for updating

  • New PIL for new product

Updated on 14 June 2017

Reasons for updating

  • Correction of spelling/typing errors

Updated on 07 March 2016

Reasons for updating

  • Change to date of revision

Updated on 06 January 2016

Reasons for updating

  • 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 4.8 has been updated to include class labeling (PAH).
Other minor editorial changes are included.

Updated on 05 January 2016

Reasons for updating

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

Updated on 06 November 2014

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 17 September 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 16 September 2014

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

  • In Section 4.4, information has been added on the occurrence of thrombotic microangiopathy in multiple sclerosis patients treated with interferon beta products, including diagnosis of the condition and subsequent patient management
  • In Section 4.8, thrombotic microangiopathy including thrombotic thrombocytopenic purpura/haemolytic uraemic syndrome has been added as a rare adverse reaction (class label for interferon beta products)
  • In Section 4.8, the contact details for the Irish Regulatory Agency have been updated, following their change of name from IMB to HPRA
  • In Section 10, the date of revision of the text has been changed to August 2014

Updated on 09 June 2014

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.3 - Shelf life
  • 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

In Section 4.4 (Special warnings and precautions for use), the following text has been added:

Nephrotic Syndrome: Cases of nephrotic syndrome with different underlying nephropathies including collapsing focal segmental glomerulosclerosis (FSGS), minimal change disease (MCD), membranoproliferative glomerulonephritis (MPGN) and membranous glomerulopathy (MGN) have been reported during treatment with interferon-beta products. Events were reported at various time points during treatment and may occur after several years of treatment with interferon-beta. Periodic monitoring of early signs or symptoms, e.g. oedema, proteinuria and impaired renal function is recommended, especially in patients at higher risk of renal disease. Prompt treatment of nephrotic syndrome is required and discontinuation of treatment with Avonex should be considered.

In Section 4.6 (Fertility, pregnancy and lactation), the following text has been added:

Fertility

Fertility and developmental studies in rhesus monkeys have been carried out with a related form of interferon beta 1a. At very high doses, anovulatory and abortifacient effects in test animals were observed (see section 5.3).

No information is available on the effects of interferon beta 1a on male fertility.

In Section 4.8 (Undesirable effects), nephrotic syndrome and glomerulosclerosis have been added as renal and urinary disorders reported rarely, and the following text has been added:

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via:

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

 

Ireland

IMB Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.imb.ie

e-mail: imbpharmacovigilance@imb.ie

 

In Section 6.3, the shelf life has been increased from 2 years to 3 years.

Updated on 09 June 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 14 August 2013

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 10 January 2013

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 10 August 2012

Reasons for updating

  • Change to section 5.2 - Pharmacokinetic 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

In Section 5.2 (Pharmacokinetic Properties)- the following statement has been removed. Intramuscular bioavailability is three-fold higher than subcutaneous bioavailability.
In Section 10 (Date of Revision of Text)- the date has been updated.

Updated on 06 August 2012

Reasons for updating

  • Change to date of revision

Updated on 04 November 2011

Reasons for updating

  • Change to date of revision
  • Change of distributor details

Updated on 04 November 2011

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

In section 4.2 (Posology and Method of Administration)- Inclusion of an alternative titration strategy has been added.
In section 4.8 (Undesirable Effects)- Information on titration reducing the incidence and severity of flu-like symptoms has been included.
In section 10: (Date of Revision of Text)- Date amended.

Updated on 01 July 2011

Reasons for updating

  • New PIL for new product

Updated on 30 June 2011

Reasons for updating

  • New SPC 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

None provided