Thalidomide BMS
*Company:
Bristol-Myers Squibb Pharma EEIGStatus:
No Recent UpdateLegal Category:
Product subject to restricted prescription (C)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
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2015-GB-2300002 - Thalidomide BMS - HCP Guide.pdf
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2015-GB-2300006 - Thalidomide BMS - CPDN Form.pdf
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2015-GB-2300011 - Thalidomide BMS - Order Form.pdf
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2015-GB-2300003 - Thalidomide BMS - Patient Guide.pdf
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2015-GB-2300004 - Thalidomide BMS - Patient Card.pdf
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2015-GB-2300010 - Thalidomide BMS - Pharmacy Registration Form.pdf
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2015-GB-2300005 - Thalidomide PAF.pdf
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2015-GB-2300009 - Thalidomide BMS - Male RAF.pdf
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2015-GB-2300014 - Thalidomide BMS - WCBP RAF.pdf
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2015-GB-2300015- Thalidomide BMS - WNCP RAF.pdf
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Thalidomide BMS - Complete Healthcare Professionals' Information Pack for Ireland.pdf
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Thalidomide BMS - Healthcare Professionals' Information Pack for Prescribers - Ireland.pdf
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Thalidomide BMS - Healthcare Professionals' Information Pack for Pharmacists - Ireland.pdf
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2015-GB-2300005 - Thalidomide PAF.pdf
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2015-GB-2300002 - Thalidomide BMS - HCP Guide.pdf
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2015-GB-2300006 - Thalidomide BMS - CPDN Form.pdf
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2015-GB-2300011 - Thalidomide BMS - Order Form.pdf
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2015-GB-2300003 - Thalidomide BMS - Patient Guide.pdf
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2015-GB-2300004 - Thalidomide BMS - Patient Card.pdf
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2015-GB-2300010 - Thalidomide BMS - Pharmacy Registration Form.pdf
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2015-GB-2300009 - Thalidomide BMS - Male RAF.pdf
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2015-GB-2300014 - Thalidomide BMS - WCBP RAF.pdf
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2015-GB-2300015- Thalidomide BMS - WNCP RAF.pdf
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Thalidomide BMS - Complete Healthcare Professionals' Information Pack for Ireland.pdf
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Thalidomide BMS - Healthcare Professionals' Information Pack for Prescribers - Ireland.pdf
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Thalidomide BMS - Healthcare Professionals' Information Pack for Pharmacists - Ireland.pdf
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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
To 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 22 March 2023
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ie-pl-13Dec2021.pdf
Reasons for updating
- Company name change or merger
- Change to marketing authorisation holder
Updated on 09 August 2022
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ie-pl-13Dec2022.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 09 August 2022
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ie-spc-13Dec2022.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to restricted prescription (C)
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THAL HCPIP Full Pack V6 IRE May2022.pdf
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Thalidomide HCP Information Pack v5.pdf
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Thalidomide Order Form Ireland.pdf
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o Version numbers updated from 5.0 to 6.0
o Updated logo throughout the pack to the BMS company logo
o Product name changed from thalidomide to Thalidomide BMS®
o Updated all references from Celgene to BMS throughout the pack
o Updated contact details and points of contacts to reflect updated processes of reporting suspected pregnancies and adverse events to BMS medical information
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Community Pharmacy Dispensing Notification Form.pdf
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o Version numbers updated from 5.0 to 6.0
o Updated logo throughout the pack to the BMS company logo
o Product name changed from thalidomide to Thalidomide BMS®
o Updated all references from Celgene to BMS throughout the pack
o Updated contact details and points of contacts to reflect updated processes of reporting suspected pregnancies and adverse events to BMS medical information
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Information for Healthcare Professionals.pdf
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Free text change information supplied by the pharmaceutical company
o Version numbers updated from 5.0 to 6.0
o Updated logo throughout the pack to the BMS company logo
o Product name changed from thalidomide to Thalidomide BMS®
o Updated all references from Celgene to BMS throughout the pack
o Updated contact details and points of contacts to reflect updated processes of reporting suspected pregnancies and adverse events to BMS medical information
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Thalidomide Pharmacy Registration Form.pdf
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- Replace File
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o Version numbers updated from 5.0 to 6.0
o Updated logo throughout the pack to the BMS company logo
o Product name changed from thalidomide to Thalidomide BMS®
o Updated all references from Celgene to BMS throughout the pack
o Updated contact details and points of contacts to reflect updated processes of reporting suspected pregnancies and adverse events to BMS medical information
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Information for Patients.pdf
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Free text change information supplied by the pharmaceutical company
o Version numbers updated from 5.0 to 6.0
o Updated logo throughout the pack to the BMS company logo
o Product name changed from thalidomide to Thalidomide BMS®
o Updated all references from Celgene to BMS throughout the pack
o Updated contact details and points of contacts to reflect updated processes of reporting suspected pregnancies and adverse events to BMS medical information
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Patient Information Pocket Card.pdf
Reasons for updating
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Free text change information supplied by the pharmaceutical company
o Version numbers updated from 5.0 to 6.0
o Updated logo throughout the pack to the BMS company logo
o Product name changed from thalidomide to Thalidomide BMS®
o Updated all references from Celgene to BMS throughout the pack
o Updated contact details and points of contacts to reflect updated processes of reporting suspected pregnancies and adverse events to BMS medical information
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Prescription Authorisation Form.pdf
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o Version numbers updated from 5.0 to 6.0
o Updated logo throughout the pack to the BMS company logo
o Product name changed from thalidomide to Thalidomide BMS®
o Updated all references from Celgene to BMS throughout the pack
o Updated contact details and points of contacts to reflect updated processes of reporting suspected pregnancies and adverse events to BMS medical information
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Male Treatment Initiation Form.pdf
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Free text change information supplied by the pharmaceutical company
o Version numbers updated from 5.0 to 6.0
o Updated logo throughout the pack to the BMS company logo
o Product name changed from thalidomide to Thalidomide BMS®
o Updated all references from Celgene to BMS throughout the pack
o Updated contact details and points of contacts to reflect updated processes of reporting suspected pregnancies and adverse events to BMS medical information
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Woman of Childbearing Potential Treatment Initiation Form.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
o Version numbers updated from 5.0 to 6.0
o Updated logo throughout the pack to the BMS company logo
o Product name changed from thalidomide to Thalidomide BMS®
o Updated all references from Celgene to BMS throughout the pack
o Updated contact details and points of contacts to reflect updated processes of reporting suspected pregnancies and adverse events to BMS medical information
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Woman of Non-Childbearing Potential Treatment Initiation Form.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
o Version numbers updated from 5.0 to 6.0
o Updated logo throughout the pack to the BMS company logo
o Product name changed from thalidomide to Thalidomide BMS®
o Updated all references from Celgene to BMS throughout the pack
o Updated contact details and points of contacts to reflect updated processes of reporting suspected pregnancies and adverse events to BMS medical information
Updated on 19 December 2021
File name
ie-spc-13Dec2021.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Company name change or merger
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Marketing Authorisation Transfer (MAT) from Celgene Europe B.V. to Bristol-Myers Squibb Pharma EEIG
Updated on 19 December 2021
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ie-pl-13Dec2021.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Company name change or merger
Updated on 08 November 2021
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ie-pl-22Oct2021.pdf
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 3 - dose and frequency
- Change to section 3 - how to take/use
- Change to section 3 - duration of treatment
- Change to section 4 - possible side effects
- 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 - date of revision
- Change to product name
Updated on 08 November 2021
File name
ie-spc-22Oct2021.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- 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 4.7 - Effects on ability to drive and use machines
- Change to section 10 - Date of revision of the text
- Change to product name
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Grouped Type IA variation:
- To change the imprints used for marking the finished product, from 'Thalidomide Celgene 50mg' to 'Thalidomide BMS 50mg'.
- To change the (invented) name of the medicinal product from ‘Thalidomide Celgene’ to ‘Thalidomide BMS’
Updated on 19 October 2021
File name
ie-pl-11Oct2021.pdf
Reasons for updating
- Change to section 6 - manufacturer
Free text change information supplied by the pharmaceutical company
QP release address change
Updated on 20 July 2021
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ie-spc-16Jul2021.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
Section 4.4, addition of general warning of hypothyroidism under sub section `Thyroid disorders'
Updated on 20 July 2021
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ie-pl-16Jul2021.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 06 April 2021
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ie-pl-25Mar2021.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 06 April 2021
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ie-spc-25Mar2021.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
Section 4.4 (Special warnings and precaution for use), inclusion of Progressive Multifocal Leukoencephalopathy (PML).
Updated on 06 April 2021
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ie-spc-25Mar2021.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to restricted prescription (C)
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Thalidomide Treatment Initiation Form (TIF) WNCBP_Aug20 v5 IRE.pdf
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Thalidomide Treatment Initiation Form (TIF) WCBP_Aug20 v5 IRE.pdf
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Thalidomide Treatment Initiation Form (TIF) Male_Aug20 v5 IRE.pdf
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Thalidomide Prescription Authorisation Form (PAF)_Aug20 v5 IRE.pdf
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Thalidomide Pharmacy Registration Form_Aug20 v5 IRE.pdf
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Thalidomide Patient Pocket Card_Aug20 v5 IRE.pdf
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Thalidomide Patient's Information Brochure_Aug20 v5 IRE.pdf
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Thalidomide Order Form_Aug20 v5 IRE.pdf
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Thalidomide Community Pharmacy Dispensing Notification Form_Aug20 v5 IRE.pdf
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Thalidomide Information for Healthcare Professional's Brochure_Aug20 v5 IRE.pdf
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- Add New Doc
Updated on 11 June 2020
File name
ie-spc-Thalidomide-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 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 6.6 (Special precautions for disposal and other handling), inclusion on product handling.
Updated on 11 June 2020
File name
ie-pl-Thalidomide-2Jun2020.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
Updated on 09 August 2019
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Thalidomide UK PIL v28 31July2019.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 09 August 2019
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Thalidomide IRE SPC v28 31July2019.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
Legal category:Product subject to restricted prescription (C)
Updated on 21 May 2019
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THALIDOMIDE PIL IRE V27 15APRIL2019.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 05 April 2019
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Thalidomide PIL IRE v26 14Feb2019.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to improve clarity and readability
Updated on 05 April 2019
File name
Thalidomide SPC IRE v26 14Feb2019.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to improve clarity and readability
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Minor editorial changes: section 4.4 and section 4.6
Updated on 21 August 2018
File name
IE Clean PIL.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to name of medicinal product
Updated on 21 August 2018
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IE Clean SPC.pdf
Reasons for updating
- 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)
Free text change information supplied by the pharmaceutical company
Change the MAH name and address from Celgene Europe Limited, 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, United Kingdom to Celgene Europe BV, Winthontlaan 6 N, 3526 KV Utrecht, Netherlands.
Updated on 14 August 2018
File name
IE PIL Clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 14 August 2018
File name
IE SPC Clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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 to Section 4.8 (Undesirable effects) of the SmPC to add the adverse reaction leukocytoclastic vasculitis with a frequency not known and section 9: Date of latest renewal has been updated to: 08 February 2018.
Updated on 09 March 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to restricted prescription (C)
Updated on 09 March 2018
Reasons for updating
- 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)
Free text change information supplied by the pharmaceutical company
Renewal of Marketing Authorisation for Thalidomide Celgene with unlimited validity AND Update to Annexes I-III
Updated on 08 March 2018
File name
PIL_14573_468.pdf
Reasons for updating
- New PIL for new product
Updated on 08 March 2018
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 14 February 2017
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 6.6 - Special precautions for disposal and other handling
- 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 10 February 2017
Reasons for updating
- Change to section 3 - how to take/use
Updated on 27 July 2016
Reasons for updating
- 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
Updated on 22 July 2016
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 03 December 2015
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
· Update to sections 4.2 and 4.8 of Annex I to add new dosing/safety information for elderly patients (>75 years) with untreated MM receiving thalidomide in combination with MP. In addition section 4.2 is updated with the recommended starting doses for melphalan and prednisone for completeness.
Updated on 02 December 2015
Reasons for updating
- Change to dosage and administration
Updated on 11 August 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)
Free text change information supplied by the pharmaceutical company
Updated on 23 July 2014
Reasons for updating
- Addition of information on reporting a side effect.
Updated on 05 August 2013
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
Change to section 4.8 to include Posterior reversible encephalopathy syndrome (PRES)/ Reversible posterior leukoencephalopathy syndrome (RPLS) as an adverse drug reaction
Updated on 11 April 2013
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 9 - Date of renewal of authorisation
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Section 4.2
· Directly after the recommended dosing guidance, monitoring of patients for neutropenia and thrombocytopenia has been added
· Two paragraphs from this change, two further paragraphs regarding neutropenia and thrombocytopenia have been added regarding the monitoring of counts and potential dose delay, reduction or discontinuation dependent on the NCI CTC (National Cancer Institute Common Toxicity Criteria) grade is advised where necessary
Section 4.4
· Two paragraphs regarding haematological disorders have been added for neutropenia and thrombocytopenia, and include reports and increased incidence of grade 3 or 4 adverse reactions in multiple myeloma patients receiving the combination of melphalan, prednisone and thalidomide (MPT)
· A paragraph on hepatic disorders has been added advising monitoring and review of concomitant medications
Section 4.8
· The headings of Table 2 have been modified to combine 'Very common' and 'Common' reactions into one heading of 'All ADRs' and the frequency is indicated within each section instead
· The section after Table 2 concerning post-marketing experience now includes gastrointestinal haemorrhage and hepatic disorders, which were highlighted in section 4.4
· The final paragraph of this section states that AML and MDS have been reported in clinical studies in patients with previously untreated MM receiving the combination of melphalan, prednisone and thalidomide (MPT), see section 4.4
Section 9
· The date of latest renewal has been updated to 16 April 2013
Updated on 05 April 2013
Reasons for updating
- Change to warnings or special precautions for use
Updated on 11 February 2013
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.4 - Special warnings and precautions for use
- 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 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- Change to section 6.5 - Nature and contents of container
- 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 3: The word 'hard' removed
Section 4.4: Lactose intolerance section removed
Section 4.6: Fertility section revised
Section 4.7: Punctuation change
Section 4.8: Grammatical changes
Section 5.1: Grammatical changes
Section 6.1: Capsule content change
Section 6.3: Shelf life is no longer 3 years
Section 6.5: Material change to container
Section 9: Format changes
Updated on 06 February 2013
Reasons for updating
- Change of inactive ingredient
- Change to improve clarity and readability
Updated on 15 January 2013
Reasons for updating
- 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 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 6.1 - List of excipients
- Change to section 9 - Date of renewal of 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
Section 2- Grammatical changes
Section 3- Added the word 'hard'
Section 4.2-
- Formatting changes
- Added full abbreviation for NCI CTC (National Cancer Institute Common Toxicity Criteria)
- Paediatric population- There is no relevant use of Thalidomide Celgene in the paediatric population in the indication of multiple myeloma
Section 4.3- Added that excipients are listed in section 6.1
Section 4.4- Grammatical and formatting changes
Section 4.5- Italicized words added.
Thalidomide is a poor substrate for cytochrome P450 isoenzymes and therefore clinically important interactions with medicinal products that are inhibitors and/or inducers of this enzyme system are unlikely. Non-enzymatic hydrolysis of thalidomide, being the primary clearance mechanism, suggests that the potential for drug-drug interactions with thalidomide is low.
Section 4.6-
- Grammatical and formatting changes
- Fertility section added
Section 4.7-
Thalidomide Celgene has minor or moderate influence on the ability to drive and use machines. Thalidomide may cause fatigue, dizziness; somnolence and blurred vision (see section 4.8).
Section 4.8- Grammatical and formatting changes
Section 5.1-
- Pharmacotherapeutic group changed to: immunosuppressants, other immunosuppressants.
- Paediatric population added.
Section 5.2-
- Metabolism changed to biotransformation
- Linearity/ non linearity added
- insufficiency changed to impairment
Section 6.1- Formatting changes
Section 9- Formatting changes
Section 10- Formatting changes
Updated on 20 September 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)
Free text change information supplied by the pharmaceutical company
4.8 Additional information regarding allergic reactions
Updated on 12 August 2011
Reasons for updating
- Change to MA holder contact details
- Change to name of manufacturer
Updated on 11 August 2011
Reasons for updating
- Change to section 10 - Date of revision of the text
- Change to MA holder contact details
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Section 10 - The date of the revision of the text has been amended
Updated on 25 May 2011
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
- 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
Section 4.4 - Changes to Cardiovascular disorders section. Addition of section regarding MI and alteration to section regarding VTE. Addition to section regarding patients with renal/hepatic impairment.
Section 4.5 - "Non-enzymatic hydrolysis suggests that the potential for drug-drug interactions with thalidomide is low." added to first paragraph.
Section 4.6 - title altered to "Fertility, pregnancy and lactation". Addition of "hypersensitivity, hearing impaired or deafness, renal failure, myocardial infarction and worsening of Parkinson’s disease symptoms" to adverse reaction experienced in post marketing surveillance.
Section 4.8 - Pancytopenia also added. Venous and arterial thromboembolic events section altered: "An increased risk of venous thromboembolism (such as deep vein thrombosis and pulmonary embolism) and arterial thromboembolism (such as myocardial infarction and cerebrovascular event) has been reported in patients treated with thalidomide (see section 4.4)."
5.1 - ATC code: L04AX 02. Previously read: LO4AX
5.2 - Sentence added: "Thalidomide is metabolised almost exclusively by non-enzymatic hydrolysis." Second paragraph added under Elimination. Additional information added to Hepatic and Renal insufficiency section.
10 – Date of revision 04/05/2011
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
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
4.8 - Tumour Lysis Syndrome added. Febrile neutropenia added as an additional AE from post marketing experience.
5.2 - Additional information added in the Metabolism, Elimination and Hepatic and Renal Insufficiency sections.
Updated on 30 April 2010
Reasons for updating
- Change to side-effects
Updated on 05 February 2010
Reasons for updating
- New PIL for medicines.ie
Updated on 07 December 2009
Reasons for updating
- Change to product name
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Updated on 31 March 2009
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Updated on 12 August 2008
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to restricted prescription (C)