Plegridy 63 mcg, 94 mcg and 125mcg solution for injection in pre-filled pen
*Company:
Biogen Idec (Ireland) 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 10 May 2023
File name
IE NI pen leaflet.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 10 May 2023
File name
IE NI Plegridy combined SPC.pdf
Reasons for updating
- 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)
Updated on 25 February 2021
File name
Plegridy_PEN_PIL_Feb_2021_IE.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 22 December 2020
File name
IE_Plegridy_combined-SmPC-en-clean_dated-Dec 2020.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 September 2019
File name
Plegridy Prefilled PEN PIL UK&IRL_Sept 2019.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 20 September 2019
File name
Plegridy Prefilled PEN SmPC UK&IRL_Sept 2019.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 08 April 2019
File name
Plegridy Prefilled Pen_PIL+UK&IRL_March 2019.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - driving and using machines
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
Updated on 08 April 2019
File name
Plegridy Prefilled PEN SmPC UK&IRL_March 2019.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Correction of spelling/typing errors
- Change from individual to joint SPC
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Changes following approval of Plegridy 5 year renewal:
- Removal of the black triangle
- Combined combine SmPC for all strengths and presentations
- Typographical and formatting corrections
SmPC section 4.4 'Special warnings and precautions for use’:
Nephrotic syndrome and Thrombotic microangiopathy (TMA) are the class effects in interferons, statement ‘class effects’ added to further clarify
SmPC section 4.7 ‘Effects on ability to drive and use machines’
Update to the section to be in line with QRD template
SmPC Section 4.8 ‘Undesirable effects’
- ADR table is updated to align with MedDRA terminology of using Preferred Terms, Angioedema is included in the ADR table however it is already listed under hypersensitivity reaction in section 4.8.
- Removal of ‘Depression and suicidal ideation’ and ‘Seizure’ from section 4.8 as this information is already presented in section 4.4.
Updated on 27 November 2018
File name
Plegridy Prefilled PEN 125 mcg SmPC UK&IRL_Oct 2018.pdf
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 Special precautions and warnings for use: hypersensitivity reactions section revised. Cases of anaphylaxis have been reported as a rare complication of treatment with interferon beta, including Plegridy. Advise is that Plegridy should be discontinued and medical care sought if signs and symptoms of anaphylaxis or severe hypersensitivity is experienced. Treatment with Plegridy should not be restarted.
SmPC Section 4.8 Undesirable effects: anaphylaxis added to table as adverse reaction with unknown frequency, hypersensitivity sub-section revised.
Updated on 02 August 2018
File name
Plegridy_Prefilled_Pen_PIL_UK_IRL_July2018.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 02 August 2018
File name
Plegridy_Prefilled_PEN_125mcg_SmPC UK_IRL_July 2018.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)
Updated on 08 May 2018
File name
Plegridy_Prefilled_Pen_PIL_UK_IRE_Apr_2018.pdf
Reasons for updating
- Change to information for healthcare professionals
Updated on 04 December 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 04 December 2017
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
Updated on 28 November 2017
File name
PIL_16249_30.pdf
Reasons for updating
- New PIL for new product
Updated on 28 November 2017
Reasons for updating
- Change to section 4 - possible side effects
Updated on 25 January 2017
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
Updated on 24 January 2017
Reasons for updating
- Change to section 4 - possible side effects
Updated on 07 March 2016
Reasons for updating
- Change to date of revision
Updated on 06 January 2016
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- 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 addition, the treatment initiation schedule has been clarified in section 4.2 and class labeling (PAH) has been added to section 4.8.
Updated on 04 January 2016
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to dosage and administration
Updated on 26 February 2015
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
Updated on 26 February 2015
Reasons for updating
- New PIL for new product