Imlygic | Medicines.ie

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Imlygic

Name:
Imlygic
Company:
Amgen Ltd
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

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.

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Company Products

Medicine Name	Active Ingredients
Medicine Name AMGEVITA prefilled pen	Active Ingredients adalimumab
Medicine Name AMGEVITA prefilled syringe	Active Ingredients adalimumab
Medicine Name Aranesp PFS	Active Ingredients Darbepoetin alfa
Medicine Name ARANESP PFS with needle guard	Active Ingredients Darbepoetin alfa
Medicine Name Aranesp SureClick	Active Ingredients Darbepoetin alfa
Medicine Name Blincyto	Active Ingredients Blinatumomab
Medicine Name Imlygic	Active Ingredients Talimogene laherparepvec
Medicine Name KANJINTI	Active Ingredients Trastuzumab
Medicine Name Kyprolis	Active Ingredients Carfilzomib
Medicine Name Mimpara Granules	Active Ingredients cinacalcet hydrochloride
Medicine Name Mimpara tablets	Active Ingredients cinacalcet hydrochloride
Medicine Name Neulasta On Body Injector	Active Ingredients Pegfilgrastim
Medicine Name Neulasta Pre-Filled Syringe	Active Ingredients Pegfilgrastim
Medicine Name Neupogen 30 MU (0.3 mg/ml) solution for injection	Active Ingredients Filgrastim
Medicine Name Neupogen Singleject 30 MU (0.6 mg/ml)	Active Ingredients Filgrastim
Medicine Name Neupogen Singleject 48 MU (0.96 mg/ml)	Active Ingredients Filgrastim
Medicine Name Nplate	Active Ingredients Romiplostim
Medicine Name Nplate reconstitution kit	Active Ingredients Romiplostim
Medicine Name Otezla 10mg, 20mg, 30mg	Active Ingredients Apremilast
Medicine Name Parsabiv	Active Ingredients etelcalcetide
Medicine Name Prolia	Active Ingredients Denosumab
Medicine Name Repatha SureClick	Active Ingredients Evolocumab
Medicine Name Vectibix	Active Ingredients Panitumumab
Medicine Name XGEVA	Active Ingredients Denosumab

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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 10⁶PFU/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

Imlygic HCP BrochureRisk Minimisation Materials
(Click to Download)

Educational Materials for Medicines

Imlygic Information for Patients and Close ContactRisk Minimisation Materials
(Click to Download)
Imlygic Patient CardRisk Minimisation Materials
(Click to Download)