Revlimid 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg hard capsules
*Company:
Bristol-Myers Squibb Pharma EEIGStatus:
No Recent UpdateLegal Category:
Product subject to restricted prescription (C)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
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2003-GB-2300019 - Revlimid WNCBP RAF.pdf
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2003-GB-2300017 - Revlimid WCBP RAF.pdf
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2003-GB-2300018 - Revlimid Male RAF.pdf
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2003-GB-2300010 - Revlimid PAF.pdf
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2003-GB-2300011 - Revlimid Pharmacy Registration Form.pdf
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2003-GB-2300029 - Revlimid Patient Card.pdf
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2003-GB-2300012 - Revlimid Order Form.pdf
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2003-GB-2300024 - Revlimid Patient Guide.pdf
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2003-GB-2300015 - Revlimid HCP Guide.pdf
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2003-GB-2300020 - Revlimid CPDN Form.pdf
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2003-GB-2300048 - Revlimid HCPIP.pdf
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2003-GB-2300025 - Revlimid HCPIP for Pharmacists.pdf
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2003-GB-2300026 - Revlimid HCPIP for Prescribers.pdf
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2003-GB-2300019 - Revlimid WNCBP RAF.pdf
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2003-GB-2300017 - Revlimid WCBP RAF.pdf
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2003-GB-2300018 - Revlimid Male RAF.pdf
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2003-GB-2300010 - Revlimid PAF.pdf
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2003-GB-2300011 - Revlimid Pharmacy Registration Form.pdf
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2003-GB-2300029 - Revlimid Patient Card.pdf
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2003-GB-2300012 - Revlimid Order Form.pdf
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2003-GB-2300024 - Revlimid Patient Guide.pdf
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2003-GB-2300015 - Revlimid HCP Guide.pdf
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2003-GB-2300020 - Revlimid CPDN Form.pdf
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2003-GB-2300048 - Revlimid HCPIP.pdf
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2003-GB-2300025 - Revlimid HCPIP for Pharmacists.pdf
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2003-GB-2300026 - Revlimid HCPIP for Prescribers.pdf
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2003-GB-2300019 - Revlimid WNCBP RAF.pdf
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2003-GB-2300017 - Revlimid WCBP RAF.pdf
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2003-GB-2300018 - Revlimid Male RAF.pdf
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2003-GB-2300010 - Revlimid PAF.pdf
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2003-GB-2300011 - Revlimid Pharmacy Registration Form.pdf
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2003-GB-2300029 - Revlimid Patient Card.pdf
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2003-GB-2300012 - Revlimid Order Form.pdf
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2003-GB-2300024 - Revlimid Patient Guide.pdf
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2003-GB-2300015 - Revlimid HCP Guide.pdf
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2003-GB-2300020 - Revlimid CPDN Form.pdf
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Updated on 03 October 2023
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ie-spc-28Sep2023.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Final Clinical Study Report (CSR) for MDS PASS (CC-5013-MDS-010) to fulfil the EU Specific condition for Revlimid (lenalidomide)
Updated on 04 August 2023
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ie-spc-26Jul2023.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Update the terminology utilised in the RMP and PI documents, relating to the safety concern of teratogenicity and its risk minimisation measure of the Pregnancy Prevention Plan.
Updated on 16 June 2023
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Revlimid IE - PIL.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Free text change information supplied by the pharmaceutical company
These changes are being introduced following the approval of version 22 of the Company Core Data Sheet (CCDS) for lenalidomide (dated 20Oct 2021).
Updated on 16 June 2023
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Revlimid IE - SPC.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
update section 5.1 of the SmPC with OS data from study CC-5013-NHL 007
Updated on 13 February 2023
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ie-spc-9Feb2023.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Update to section 5.1 of the SmPC with OS data from study CC-5013-NHL 007
Updated on 28 October 2022
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ie-spc-14Oct2022.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
• Update of section 4.2 of the SmPC to update the dosage for patients with impaired renal function (severe renal impairment and end stage renal disease) for the follicular lymphoma (FL) indication based on additional PK analysis.
• In addition, the MAH proposed to update the existing warning in section 4.4 of the SmPC to highlight that male patients should not donate semen or sperm during treatment and for at least seven days after the end of treatment in order to align with the Revlimid Annex IID requirements for the patient educational brochures and to align with similar wording in the Imnovid (pomalidomide) and Thalidomide BMS (thalidomide) SmPC.
Updated on 28 October 2022
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ie-pl-14Oct2022.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
Updated on 07 October 2022
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ie-pl-imp2Dec2021.pdf
Reasons for updating
- Previous version of PIL reinstated
Updated on 07 October 2022
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ie-spc-16Sept2021.pdf
Reasons for updating
- Previous version of SPC reinstated
Legal category:Product subject to restricted prescription (C)
Updated on 22 September 2022
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ie-spc-15Sept2022.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
- Update of section 4.2 of the SmPC to update the dosage for patients with impaired renal function (severe renal impairment and end stage renal disease) for the follicular lymphoma (FL) indication based on additional PK analysis.
- In addition, the MAH proposed to update the existing warning in section 4.4 of the SmPC to highlight that male patients should not donate semen or sperm during treatment and for at least seven days after the end of treatment in order to align with the Revlimid Annex IID requirements for the patient educational brochures and to align with similar wording in the Imnovid (pomalidomide) and Thalidomide BMS (thalidomide) SmPCs.
Updated on 22 September 2022
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ie-pl-15Sept2022.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
Free text change information supplied by the pharmaceutical company
Update the existing warning in section 2 of the PIL to highlight that male patients should not donate semen or sperm during treatment and for at least seven days after the end of treatment in order to align with the Revlimid Annex IID requirements for the patient educational brochures
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Revlimid (lenalidomide) - Additional Risk Minimisation Materials for Pharmacists - IRE Jul22.pdf
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Revlimid (lenalidomide) - Additional Risk Minimisation Materials for Prescribers - IRE Jul22.pdf
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2003-GB-2200029 - Lenalidomide WNCBP Treatment Initiation Forms Jul-22.pdf
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2003-GB-2200027 - Lenalidomide WCBP Treatment Initiation Forms Jul-22.pdf
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2003-GB-2200028 - Lenalidomide Male Treatment Initiation Forms Jul-22.pdf
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2003-GB-2200019 - Lenalidomide Prescription Authorisation Form Jul-22.pdf
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2003-GB-2200023 - Revlimid Pharmacy Registration Form IRE Mar22.pdf
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2003-GB-2200021 - Lenalidomide Patient Pocket Card Jul-22.pdf
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2003-GB-2200018 - Revlimid Order Form Jul-22.pdf
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2003-GB-2200020 - Lenalidomide Patient Guide Jul-22.pdf
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2003-GB-2200017 - Revlimid Healthcare Professional Information Guide Jul-22.pdf
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2003-GB-2200016 - Lenalidomide Community Pharmacy Dispensing Notification Form Jul-22.pdf
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Updated on 14 January 2022
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ie-pl-imp2Dec2021.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 21 September 2021
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ie-spc-16Sept2021.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Update of section 4.4 of the SmPC to update the warning for Tumour flare reaction and tumour lysis syndrome.
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Revlimid®▼(lenalidomide) Treatment Initiation Form (TIF) WNCBP_Jan21 v6 IRE.pdf
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Revlimid®▼(lenalidomide) Treatment Initiation Form (TIF) WCBP_Jan21 v6 IRE.pdf
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Revlimid®▼(lenalidomide) Treatment Initiation Form (TIF) Male_Jan21 v6 IRE.pdf
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Revlimid®▼(lenalidomide) Prescription Authorisation Form (PAF)_Jan21 v6 IRE.pdf
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Revlimid®▼(lenalidomide) Pharmacy Registration Form_Jan21 v6 IRE.pdf
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Revlimid®▼(lenalidomide) Patient Information Pocket Card_Jan21 v6 IRE.pdf
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Revlimid®▼(lenalidomide) Order Form_Jan21 v6 IRE.pdf
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Revlimid®▼(lenalidomide) Information for Patients Brochure_Jan21 v6 IRE.pdf
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Revlimid®▼(lenalidomide) Information for Healthcare Professionals Brochure_Jan21 v6 IRE.pdf
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Revlimid®▼(lenalidomide) Community Pharmacy Dispensing Notification Form_Jan21 v6 IRE.pdf
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Revlimid®▼(lenalidomide) Prescription Authorisation Form (PAF)_Aug20 v5 IRE.pdf
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Revlimid®▼(lenalidomide) Information for Healthcare Professionals Booklet_Aug20 v5 IRE.pdf
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Revlimid®▼(lenalidomide) Pharmacy Registration Form_Aug20 v5 IRE.pdf
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Revlimid®▼(lenalidomide) Treatment Initiation Form (TIF) Male_Aug20 v5 IRE.pdf
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Revlimid®▼(lenalidomide) Treatment Initiation Form (TIF) WNCBP_Aug20 v5 IRE.pdf
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Revlimid®▼(lenalidomide) Treatment Initiation Form (TIF) WCBP_Aug20 v5 IRE.pdf
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Revlimid®▼(lenalidomide) Patient Information Pocket Card_Aug20 v5 IRE.pdf
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Revlimid®▼(lenalidomide) Order Form_Aug20 v5 IRE.pdf
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Revlimid®▼(lenalidomide) Information for Patients Brochure_Aug20 v5 IRE.pdf
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Revlimid®▼(lenalidomide) Community Pharmacy Dispensing Notification Form_Aug20 v5 IRE.pdf
Reasons for updating
- Add New Doc
Updated on 27 November 2020
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ie-pil-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
- Company name change or merger
Updated on 27 November 2020
File name
ie-spc-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
- Company name change or merger
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
In section 7 (Marketing Authorisation Holder). ‘Bristol-Myers Squibb Pharma EEIG, Plaza 254 Blanchardstown Corporate Park 2 Dublin 15, D15 T867, Ireland’ has replaced the previous text which was ‘Celgene Europe B.V. Winthontlaan 6 N 3526KV Utrecht Netherlands’
Updated on 02 October 2020
File name
ie-pl-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 02 October 2020
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ie-spc-clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
In section 4.4 (Special warnings and precautions for use), to add the additional ADR Pulmonary hypertension.
In section 4.8 (Undesirable effects), to add the additional ADR Pulmonary hypertension.
Updated on 03 July 2020
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ie-spc-2Jun2020.pdf
Reasons for updating
- Other
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Print to PDF did not complete for the full document. Pages were missing.
Updated on 05 June 2020
File name
ie-pl-2Jun2020.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
Updated on 05 June 2020
File name
ie-spc-2Jun2020.pdf
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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.1 - List of excipients
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
In section 4.2 (Posology and method of administration), update to now read anaphylactic reaction.
In section 4.4 (Special warnings and precautions for use), inclusion on product handling.
In section 4.8 (Undesirable effects), update to now read anaphylactic reaction and consolidation of subsection 'Allergic reactions and severe skin reactions'
In section 5.1 (Pharmacodynamic properties), update on the cyles days for sub section 'Lenalidomide in combination with bortezomib and dexamethasone in patients who are not eligible for stem cell transplantation'.
In section 6.1 (List of excipients), inclusion of E number for Propylene glycol.
In Section 6.6 (Special precautions for disposal and other handling), inclusion on product handling.
Updated on 07 January 2020
File name
ie-spc-clean.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
In section 4.1 (Therapeutic indications), add a new additional indication 'Follicular lymphoma'
In section 4.2 (Posology and method of administration), add a new additional indication 'Follicular lymphoma', new posology Tumour lysis syndrome (TLS), update to Tumour flare reaction
In section 4.4 (Special warnings and precautions for use), add a new additional indication 'Follicular lymphoma', update to Neutropenia and thrombocytopenia warning, update to Tumour flare reaction and tumour lysis syndrome warning, update Second primary malignancies in follicular lymphoma warning
In section 4.6 (Fertility, pregnancy and lactation), update to pregnancy sub-section
In section 4.8 (Undesirable effects), add a new additional indication 'Follicular lymphoma'
In section 5.1 (Pharmacodynamic properties), add a new additional indication 'Follicular lymphoma' and update to sub-sections: mechanism of action, Clinical efficacy and safety
Updated on 07 January 2020
File name
ie-pl-clean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
Updated on 21 May 2019
File name
REVLIMID PIL IRE V48.0 13May2019.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - dose and frequency
- Change to section 4 - possible side effects
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 21 May 2019
File name
REVLIMID SPC IRE V48.0 13May2019.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Updated on 20 March 2019
File name
IE Clean PIL.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 26 November 2018
File name
IE Clean PIL.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 26 November 2018
File name
IE Clean SPC.pdf
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Updated on 19 July 2018
File name
Revlimid IE SmPC19-07-18.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 restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Update to section 4.8 "Solid Organ Transplant Rejection"
Updated on 18 July 2018
File name
Revlimid IE PIL.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 14 May 2018
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to restricted prescription (C)
Updated on 05 October 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to restricted prescription (C)
Updated on 05 October 2017
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 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Update of Annex I (Sections 4.2, 4.4, 4.8), and Annex IIIB
Introduction of dose modifications in case of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), to add a relevant warning and to include DRESS in the list of adverse reactions with a frequency unknown
Updated on 04 October 2017
File name
PIL_16257_925.pdf
Reasons for updating
- New PIL for new product
Updated on 04 October 2017
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 31 May 2017
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Extension of indication to add treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who have undergone autologous stem cell transplantation (ASCT). Consequently SmPC sections 4.1, 4.2, 4.4, 4.8 and 5.1 have been updated with the efficacy and safety data. Furthermore, the MAH introduced 7-day pack sizes for the 10 mg and 15 mg strengths with subsequent changes to the Product Information.
All strenghs of the product are now all on 1 SPC.
Updated on 18 May 2017
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 2 - interactions with other medicines, food or drink
- 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 3 - dose and frequency
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 3 - duration of treatment
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 16 February 2017
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
- Update of Annex I and Annex III-B and Annex III-B
o section 4.4 and 4.8 of the SmPC and the corresponding sections of the PIL to implement the wording agreed by the PRAC/CHMP regarding the risk of viral reactivation.
o Update to sections 6.6 of the SmPC and corresponding section of the PIL with additional guidance on product handling.
o Update according to the latest QRD template (v 10.0) and some other minor editorial changesUpdated on 16 February 2017
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
Updated on 17 October 2016
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 restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Updated on 23 September 2016
Reasons for updating
- Change to date of revision
Updated on 14 September 2016
Reasons for updating
- Improved electronic presentation
Updated on 26 August 2016
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Updated on 12 August 2016
Reasons for updating
- Change to date of revision
- Change to dosage and administration
Updated on 27 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 4.4 - Special warnings and precautions for use
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Updated on 19 July 2016
Reasons for updating
- Change to improve clarity and readability
Updated on 07 August 2015
Reasons for updating
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Updated on 02 April 2015
Reasons for updating
- Addition of black triangle
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Updated on 27 March 2015
Reasons for updating
- Addition of black triangle
Updated on 11 March 2015
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- 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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of renewal of authorisation
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Section 2 – wording updated
Section 3 – description of capsule updated
Section 4.1 –indications updated
Section 4.2 –new section included for new indication
Section 4.2 – existing indication updated
Section 4.3 - order of contraindications updated
Section 4.4 – wording updated and new information for new indication added
Section 4.5 – Wording updated
Section 4.8 – new sections included for added new indication
Section 4.8 – undesirable effects updated
Section 5.1 – new sections included for added new indication
Section 5.2 – Wording updated
Section 6.5 – Description updated
Section 6.6 – wording updated
Section 9 – wording updated
Updated on 05 March 2015
Reasons for updating
- New PIL for medicines.ie
Updated on 26 November 2014
Reasons for updating
- Change to separate SPCs covering individual presentations
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Updated on 17 October 2014
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.2 - Pharmacokinetic properties
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SPC has been amended to address changes required in the following regulatory procedure:
- II/070 - update of sections 4.2, 4.5 and 5.2 of the EU SmPC following the availability of new clinical pharmacology data including; the drug interaction potential of lenalidomide
Updated on 15 October 2014
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.2 - Pharmacokinetic properties
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· Section 4.2 Posology and method of administration – Amendment of the paragraph for older people, stating PK data is in section 5.2
· Section 4.5 Interaction with other medicinal products and other forms of interaction – Addition of a paragraph for interations with dexamethasone; amendment to the paragraph for interaction with P-glycoprotein inhibitors
· Section 4.8 Undesirable effects – Addition of a final paragraph regarding adverse event reporting
· Section 5.2 Pharmacokinetic properties –
o Addition of a final paragraph regarding the oral absorption rate for MM and MDS patients
o Amendment to the paragraph on biotransformation and elimination
o Addition of a paragraph on older people
o Addition of a paragraph on hepatic impairment
o Addition of a paragraph outlining other intrinsic factors (e.g. weight, gender etc.)
Updated on 30 July 2014
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to restricted prescription (C)
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Updated on 13 June 2014
Reasons for updating
- Correction of spelling/typing errors
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Updated on 14 April 2014
Reasons for updating
- 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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
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· Update of sections 4.4 and 4.8 with the adverse drug reaction “hyperthyroidism” and “leucocytoclastic vasculitis“
· Update of section 4.8 with the adverse drug reaction “weight decreased” applicable to 2.5mg, 5mg and10mg strengths only.
· Revisions to section 4.4, 4.5, 4.6, 4.8 and 5.1 with grammatical amends
Updated on 06 December 2013
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
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Interraction between lenalidomide and statins reported
Section 4.8:
Rhabdomyolysis included as a rare side efect reported with the use of lenaldiomide and statins
Updated on 28 June 2013
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to restricted prescription (C)
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Section 4.1
Addition of myelodysplastic syndromes (MDS) to therapeutic indication
Section 4.2
Addition of MDS to posolgy and method of administration
Section 4.4
Additional information for female patients regarding amenorrhoea and lactation and male patients and contraception
Updates to educational materials
Updated information for venous thromboembolism for MDS patients
Updated information for Neutropenia and thrombocytopenia for MM patients
Progression to AML and TP53 status for MDS patients
Section 4.8
Addition of undesirable effects for MDS indication
Section 4.9
Overdose section has been generalized to include both indications
Section 5.1
Addition of MDS data
Section 5.2
Addition of MDS data
Updated on 12 February 2013
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 6.1 - List of excipients
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Section 1- Addition of 2.5 mg and 7.5 mg strengths
Section 2- Addition of 2.5 mg and 7.5 mg strengths and description of excipient for both strengths
Section 3- Addition of the following:
Pale yellow/white capsules marked “REV 7.5 mg”.
Blue-green/white capsules marked “REV 2.5 mg”.
Section 4.2- Changes to renal table which includes 7.5 mg dose as an option for severe renal impairment in countries where it is available
Section 6.1- Description of excipients within the capsule contents, shell and printing ink for both 2.5 mg and 7.5 mg strengths
Updated on 13 December 2012
Reasons for updating
- 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 4.8 - Undesirable effects
Legal category:Product subject to restricted prescription (C)
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4.4 Special warnings and precautions for use - Additional two paragraphs added to the end of the section entitled 'Hepatic Disorders', cautioning usage in patients with impaired hepatic function and suggestions for monitoring/dose interruption.
4.5 Interaction with other medicinal products and other forms of interaction - Additional paragraph: 'Interactions with other medicines'
4.8 Undesirable effects:
- Table 1 contains more adverse drug reactions (all and Grade 3-4) for Hepatobiliary Disorders
- Additional paragraph at the end of the section 'Hepatic Disorders' reporting the frequency of hepatic related conditions
Updated on 20 September 2012
Reasons for updating
- Change to improve clarity and readability
Legal category:Product subject to restricted prescription (C)
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Updated on 02 May 2012
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- 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 4.6 - 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 6.5 - Nature and contents of container
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
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- Section 2 (qualitative and quantitative composition) - excipients with known effect are listed only here
- Section 4.1 (therapeutic indications) - specified that revlimid is indicated in adults
- Section 4.2 (posology and method of administration) - administration section has moved from second paragraph to the end of the section
- Special populations are titled together
- Wording has changed from patients to populations for all of these groups
- Safety and efficacy in 0-17yr olds has been altered to say 'no data available' rather than 'do not use'
- Section 4.3 (contraindications) - highlights that excipients are listed in section 6.1
- Section 4.4 (special warnings and precautions for use) - wording in counselling section has changed: contraceptive measure rather than treatment
- The word substance is used rather than drug
- Section 4.5 (interaction with other medicinal products and other forms of interaction) - Final section of Oral contraceptives regarding metabolic studies has been moved to the end of this section
- Section 4.6 (fertility, pregnancy and lactation) - Two paragraphs, regarding women of childbearing potential and revlimid levels in semen, originally under the pregnancy sub-heading are now at the start of the section
- Fertility studies in rats showing no genetic toxicity has been included
- Section 4.7 (effects on ability to drive and use machines) - No longer states that no studies have been performed, but still provides a cautionary note
- Section 4.8 (undesirable effects) - does not specify safety in multiple myeloma patients anymore
- Removed the paragraph outlining the efficacy & safety data for the two major registration trials MM-09 & MM-10 (already contained in section 5.1)
- Updated the statistics of most frequently observed adverse event section
- Removed text regarding rairy and isolated reports
- Includes post-marketing data in the title of Table 1, rather than at the bottom
- Tumour lysis syndrome, interstitial pneumonitis, pancreatitis, angioedema, Stevens-Johnson Syndrome, toxic epidermal necrolysis have been added
- Table 2 containing post-marketing data has been removed an incorporated into Table
- Section 5.1 (pharmacodynamic properties) - Sub-heading have been added and altered slightly
- Statement that the EMA has waived the obligation to perform pediatric studies in multiple myeloma
- The word substance is used rather than drug
- Section 6.5 (nature and contents of container) - Wording has altered but the content is the same regarding technical particulars
- Section 9 (date of the first authorisation/renewal of the authorisation) - Wording added
- Section 10 (date of revision of the text) - 13th April 2012
Updated on 12 March 2012
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to restricted prescription (C)
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Paragraph added regarding the incidence of second primary malignancies, and the risk of occurence of SPM should be taken into account pior to initiating treatment with lenalidomide
Section 4.8 Undesirable effects
Squamous skin cancer added into Table 1.
Small section on second primary malignancies and basal cell or squamous cell skin cancers.
Updated on 21 July 2011
Reasons for updating
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
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Section 5.2 - Minor alterations to first paragraph in the absorption section and an addition of a second paragraph regarding administration with or without food.
Distribution section - Alteration of figures to 23% and 29% from 22.7% and 29.2% with respect to plasma protein binding.
Metabolism and excretion section - Deletion of final sentence in first paragraph and addition of faecal excretion percentage. Additional paragraph entered regarding metabolism of lenalidomide. Final paragraph removed.
Section 7.0 - Change of address of MA holder to
Celgene Europe Limited
1 Longwalk Road
Stockley Park
Uxbridge
UB11 1DB
Section 10 - change of date of revision of text to 26/05/11
Updated on 08 February 2011
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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
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Section 4.4: Additional information added under sections "Cardiovascular disorders", regarding Myocardial Infarction and Venous and Arterial Thromboembolic Events.
Section 4.6: Title altered to "Fertility, Pregnancy and Lactation"
Section 4.8: Adverse Events put into a tabular format. Table 2 regarding adverse reactions noted from post marketing data has been added. Description of selected adverse reactions has been added.
Section 4.9: 50mg changed to 150mg. Addition to first sentence stating: "and in single-dose studies, some patients were exposed to up to 400 mg."
Section 5.1: Exploratory study added
Section 10: Date or Revision updated to 04/11/2010
Updated on 10 May 2010
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
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Section 4.8 - Myocardial Infarction added as a common side effect to Cardiovascular Disorders. Interstitial pneumonitis (frequency unknown) added to Respiratory, thoracic and mediastinal disorders. Pancreatitis (frequency unknown) added to Gastrointestinal disorders.
Updated on 15 February 2010
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.4 - Special precautions for storage
- Change to section 10 - Date of revision of the text
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In section 4.6 (Preganancy and lactation) this same information has been added (above).
In section 5.1 (Pharmacodynamic properties) extended follow up data has been added regarding the MM 009 and MM 010 studies.
In section 5.3 (Preclinical safety data) more detail regarding the findings of an embryofoetal malformation study conducted in monkeys has been added. Preliminary findings have been removed.
In section 6.4 (Special precautions for storage): This has changed to "no special storage conditions" being required and the original precaution of "Do not store above 25C" has been removed.
Section 10: date of revision of text updated to 12/01/2010.
Updated on 02 December 2009
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Summary of changes include:
Section 4.4 Special Warnings and Precautions
Under special warning for venous thromboembolism – the threshold for haemoglobin concentration above which erythropoietic agents must be discontinued has changed from 13 to 12 g/dl.
Special warnings added for Allergic Reactions and Severe skin reactions.
Section 4.8 Undesirable Effects
Tumour lysis syndrome and Hypersensitivity reactions are added as rare events
Updated on 31 March 2009
Reasons for updating
- Change to section 4.2 - Posology and method of administration
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Updated on 28 October 2008
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Updated on 11 August 2008
Reasons for updating
- New SPC for medicines.ie
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