Imlygic

  • Name:

    Imlygic

  • Company:
    info
  • Active Ingredients:

    Talimogene laherparepvec

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 26/04/19

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Summary of Product Characteristics last updated on medicines.ie: 26/4/2019
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

Click on this link to Download PDF directly

Amgen Ireland Ltd

Amgen Ltd

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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 26 April 2019 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to MA holder contact details

Updated on 26 April 2019 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

Addition of final results from study to investigate talimogene laherparepvec DNA in blood, urine, injection site, exterior of the occlusive dressings, oral mucosa, anogenital area, and suspected herpetic lesions.

Updated on 16 January 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 16 January 2019 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)

Updated on 16 January 2019 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)

Updated on 29 August 2018 Ed-Ptnt

Reasons for updating

  • Add New Doc

Free text change information supplied by the pharmaceutical company

This IMLYGIC patient alert card includes contact details of the IMLYGIC prescriber, treatment start date, IMLYGIC batch number and information on the potential development of herpetic lesions and the importance of reporting ADRs. To request a copy of the patient card, please contact Amgen Medical Information on +44 (0) 1223 436441

Updated on 29 August 2018 Ed-Ptnt

Reasons for updating

  • Add New Doc

Free text change information supplied by the pharmaceutical company

This brochure contains important safety information you should know before and during IMLYGIC treatment. Please read this information carefully before and after each treatment. Please also read the IMLYGIC Package Leaflet. To request a copy of this guide, please contact Amgen Medical Information on +44 (0) 1223 436441

Updated on 29 August 2018 Ed-HCP

Reasons for updating

  • Add New Doc

Free text change information supplied by the pharmaceutical company

This educational brochure contains important information regarding the risks of transmission and herpetic complications, and safe use and handling of IMLYGIC.This brochure does not contain a comprehensive description of the risks associated with IMLYGIC. Please read the current Summary of Product Characteristics (SmPC) for IMLYGIC. To request a copy of the brochure, please contact Amgen Medical Information on +44 (0) 1223 436441

Updated on 7 August 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 6 August 2018 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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), addition of statement to help improve the overall monitoring of potential herpetic infections
  • In section 10, the date of revision has been updated to July 2018

Updated on 3 August 2018

Updated on 29 June 2018 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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 3 Pharmaceutical form

Clarification regarding appearance of 106 strength:

It may contain white, visible, variously shaped, virus-containing particles.

 

Section 4.4 Special warnings and precautions for use

Update to warnings for excipients per new EU template text:   

 

Section 4.8 Undesirable effects

  • Clarification that table includes data from clinical trials and post-marketing experience
  • Addition of hypersensitivity as an uncommon adverse reaction

Section 10 Date of revision of the text

May 2018

Updated on 29 June 2018 PIL

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 28 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 24 May 2018 SmPC

Reasons for updating

  • 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

Shelf life updated to 5 years

Reduction to stability period for thawed product

Updated on 24 May 2018 PIL

Reasons for updating

  • Change to information for healthcare professionals

Updated on 3 May 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 3 May 2017 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • 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

Addition of vial sleeve presentation

Updated on 28 July 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 28 July 2016 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic 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

Addition of ATC code (L01XX51) 
New storage condition for finished product in vials after thawing at 25°C: 17 hours for 106 PFU/mL and 85 hours for 108 PFU/mL.

Shelf-life of 8 hours for 106 PFU/mL and 16 hours at 108 PFU/mL at 2°C to 8°C for finished product packed in administration syringes

Shelf-life of: 2.5 hours for 106 PFU/mL and 4 hours for 108 PFU/mL at 25°C for finished product in administration syringe

Extend storage time of finished product in vials after thawing from 12 hours to 31 hours for 106 PFU/mL and from 48 hours to 6 weeks (42 days) for 108 PFU/mL at 2°C to 8°C.

Add needle gauge information to section 4.2

Updated on 28 July 2016 PIL

Reasons for updating

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

Updated on 23 December 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 23 December 2015 PIL

Reasons for updating

  • New PIL for new product