Imlygic * Pharmacy Only: Prescription
Company:
Amgen Ireland LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 21 April 2022
File name
en_imlygic_approved_pil_v48_CDSv12_1650551937.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 21 April 2022
File name
en_imlygic_approved_spc_v48_CDSv12_1650551902.pdf
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)
File name
2960_IMLYGIC_BROCHURE_HCPs_IRELAND_FINAL Feb21_1621952558.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Update to RMM following renewal of marketing authorisation
File name
3083_IMLYGIC_PATIENT_CARD_IRELAND_FINAL Feb21_1621952558.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Update to RMM following renewal of marketing authorisation
File name
2961_IMLYGIC_BROCHURE_PATIENTS_IRELAND_FINAL Feb21_1621952497.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Update to RMM following renewal of marketing authorisation
Updated on 24 November 2020
File name
en_imlygic_approved_pil_r39_renewal_1606219167.pdf
Reasons for updating
- Change to section 6 - date of revision
- Removal of Black Inverted Triangle
- Improved presentation of PIL
Updated on 24 November 2020
File name
en_imlygic_approved_spc_r39_renewal_1606219019.pdf
Reasons for updating
- Change to section 10 - Date of revision of the text
- Removal of Black Inverted Triangle
- Updated inline with QRD template and/or excipient guideline
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Editorial updates to align with latest QRD template
Removal of black triangle
Updated on 26 April 2019
File name
en_imlygic_approved_pil_v29_1556279164.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to MA holder contact details
Updated on 26 April 2019
File name
en_imlygic_approved_spc_v29_1556279266.pdf
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
File name
en_imlygic_approved_pil_v27_1547646407.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 16 January 2019
File name
en_imlygic_approved_spc_v27_1547646374.pdf
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
File name
en_imlygic_approved_spc_v27_1547646355.pdf
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)
File name
2961_TVEC_Safety Brochure_IRELAND_V3_080115 FINAL.pdf
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
File name
3083_TVEC_ Patient Alert Card_IRELAND_V4_060116 FINAL.pdf
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
File name
2960_TVEC_Physician Brochure_IRELAND_V4_120116 FINAL.pdf
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 07 August 2018
File name
en_imlygic_approved_pil_PSURv04_1533548507.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 06 August 2018
File name
en_imlygic_approved_spc_PSURv04_1533548651.pdf
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
File name
en_imlygic_approved_pil_v20.pdf
Updated on 29 June 2018
File name
en_imlygic_approved_spc_v20.docx
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.
|
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Section 4.4 Special warnings and precautions for use |
Update to warnings for excipients per new EU template text:
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Section 4.8 Undesirable effects |
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Section 10 Date of revision of the text |
May 2018 |
Updated on 29 June 2018
File name
en_imlygic_approved_pil_v20.pdf
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
File name
32428.docx
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 24 May 2018
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
File name
en_imlygic_approved_pil_v21.pdf
Reasons for updating
- Change to information for healthcare professionals
Updated on 03 May 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 03 May 2017
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
File name
PIL_16571_767.pdf
Reasons for updating
- New PIL for new product
Updated on 28 July 2016
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
Reasons for updating
- Change to storage instructions
- Change to further information section
- Change to date of revision
Updated on 23 December 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 23 December 2015
Reasons for updating
- New PIL for new product