Imlygic
- Name:
Imlygic
- Company:
Amgen Ireland Ltd
- Active Ingredients:
- 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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Amgen Ireland Ltd
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 MVASI | Active Ingredients Bevacizumab |
| 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 |
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 |
|
|
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
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
Updated on 23 December 2015 PIL
Reasons for updating
- New PIL for new product
Imlygic HCP BrochureRisk Minimisation Materials
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Educational Materials for Medicines
Educational Materials for Medicines
Imlygic Information for Patients and Close ContactRisk Minimisation Materials
(Click to Download)Imlygic Patient CardRisk Minimisation Materials
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Educational Materials for Medicines
Educational Materials for Medicines