Plegridy 63 mcg, 94 mcg and 125mcg solution for injection in pre-filled pen

  • Name:

    Plegridy 63 mcg, 94 mcg and 125mcg solution for injection in pre-filled pen

  • Company:
    info
  • Active Ingredients:

    peginterferon 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 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 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 8 April 2019 PIL

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 8 April 2019 SmPC

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 SmPC
  • 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 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 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 2 August 2018 PIL

Reasons for updating

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

Updated on 2 August 2018 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)

Updated on 8 May 2018 PIL

Reasons for updating

  • Change to information for healthcare professionals

Updated on 4 December 2017 SmPC

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

Addition of class labeling (alopecia)

Updated on 4 December 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 28 November 2017 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 28 November 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 25 January 2017 SmPC

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

 
Details of an open-label study in patients switching from interferon beta therapy to Plegridy evaluating the onset and duration of prophylactically treated flu-like symptoms added.

Updated on 24 January 2017 PIL

Reasons for updating

  • Change to section 4 - possible side effects

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 4.2 - 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

A number of minor editorial changes are included with this update.

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 4 January 2016 PIL

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 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

Updated on 26 February 2015 PIL

Reasons for updating

  • New PIL for new product