AVONEX 30 micrograms/0.5ml solution for injection, in pre-filled pen * Pharmacy Only: Prescription
Company:
Biogen Idec LtdStatus:
No Recent UpdateLegal 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
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
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
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 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 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 4.8 (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 04 November 2011
Reasons for updating
- Change to date of revision
- Change of distributor details
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)