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

  • Name:

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

  • Company:
    info
  • Active Ingredients:

    Interferon beta-1a

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 20/09/19

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 20/9/2019

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Biogen Idec Ltd

Biogen Idec Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name AVONEX 30 micrograms/0.5 ml solution for injection Active Ingredients Interferon beta-1a
Medicine Name AVONEX 30 micrograms/0.5ml solution for injection, in pre-filled pen Active Ingredients Interferon beta-1a
Medicine Name Benepali 25mg solution for injection in pre-filled syringe Active Ingredients Etanercept
Medicine Name Benepali 50 mg solution for injection in pre-filled pen Active Ingredients Etanercept
Medicine Name Benepali 50 mg solution for injection in pre-filled syringe Active Ingredients Etanercept
Medicine Name Fampyra 10 mg prolonged-release tablets Active Ingredients Fampridine
Medicine Name Flixabi 100 mg powder for concentrate for solution for infusion Active Ingredients Infliximab
Medicine Name Imraldi 40 mg solution for injection in pre-filled syringe Active Ingredients adalimumab
Medicine Name Imraldi 40mg solution for injection in pre-filled pen Active Ingredients adalimumab
Medicine Name Plegridy 63 mcg, 94 mcg and 125mcg solution for injection in pre-filled pen Active Ingredients peginterferon beta-1a
Medicine Name Spinraza 12 mg solution for injection Active Ingredients Nusinersen sodium
Medicine Name Tecfidera 120mg and 240mg gastro-resistant hard capsules Active Ingredients Dimethyl fumarate
Medicine Name Tysabri 300mg concentrate for solution for infusion Active Ingredients Natalizumab
1 - 0 of 13 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 20 September 2019 SmPC

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 PIL

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 8 April 2019 PIL

Reasons for updating

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

Updated on 8 April 2019 SmPC

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 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 26 June 2017 SmPC

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 PIL

Reasons for updating

  • New PIL for new product

Updated on 14 June 2017 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 7 March 2016 PIL

Reasons for updating

  • Change to date of revision

Updated on 6 January 2016 SmPC

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 5 January 2016 PIL

Reasons for updating

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

Updated on 6 November 2014 PIL

Reasons for updating

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

Updated on 17 September 2014 PIL

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 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 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 9 June 2014 PIL

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 9 June 2014 SmPC

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 14 August 2013 PIL

Reasons for updating

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

Updated on 10 January 2013 PIL

Reasons for updating

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

Updated on 10 August 2012 SmPC

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 6 August 2012 PIL

Reasons for updating

  • Change to date of revision

Updated on 4 November 2011 PIL

Reasons for updating

  • Change to date of revision
  • Change of distributor details

Updated on 4 November 2011 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

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 1 July 2011 PIL

Reasons for updating

  • New PIL for new product

Updated on 30 June 2011 SmPC

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