Thalidomide BMS

*
Pharmacy Only: Prescription
  • Company:

    Bristol-Myers Squibb Pharma EEIG
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to restricted prescription (C)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

EDM Updated on 15 February 2024

File name

2015-GB-2300002 - Thalidomide BMS - HCP Guide.pdf

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EDM Updated on 15 February 2024

File name

2015-GB-2300006 - Thalidomide BMS - CPDN Form.pdf

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EDM Updated on 15 February 2024

File name

2015-GB-2300011 - Thalidomide BMS - Order Form.pdf

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EDM Updated on 15 February 2024

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2015-GB-2300003 - Thalidomide BMS - Patient Guide.pdf

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EDM Updated on 15 February 2024

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2015-GB-2300004 - Thalidomide BMS - Patient Card.pdf

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EDM Updated on 15 February 2024

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2015-GB-2300010 - Thalidomide BMS - Pharmacy Registration Form.pdf

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EDM Updated on 15 February 2024

File name

2015-GB-2300005 - Thalidomide PAF.pdf

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EDM Updated on 15 February 2024

File name

2015-GB-2300009 - Thalidomide BMS - Male RAF.pdf

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EDM Updated on 15 February 2024

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2015-GB-2300014 - Thalidomide BMS - WCBP RAF.pdf

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EDM Updated on 15 February 2024

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2015-GB-2300015- Thalidomide BMS - WNCP RAF.pdf

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EDM Updated on 15 February 2024

File name

Thalidomide BMS - Complete Healthcare Professionals' Information Pack for Ireland.pdf

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EDM Updated on 15 February 2024

File name

Thalidomide BMS - Healthcare Professionals' Information Pack for Prescribers - Ireland.pdf

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EDM Updated on 15 February 2024

File name

Thalidomide BMS - Healthcare Professionals' Information Pack for Pharmacists - Ireland.pdf

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EDM Updated on 15 February 2024

File name

2015-GB-2300005 - Thalidomide PAF.pdf

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EDM Updated on 15 February 2024

File name

2015-GB-2300002 - Thalidomide BMS - HCP Guide.pdf

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EDM Updated on 15 February 2024

File name

2015-GB-2300006 - Thalidomide BMS - CPDN Form.pdf

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EDM Updated on 15 February 2024

File name

2015-GB-2300011 - Thalidomide BMS - Order Form.pdf

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EDM Updated on 15 February 2024

File name

2015-GB-2300003 - Thalidomide BMS - Patient Guide.pdf

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EDM Updated on 15 February 2024

File name

2015-GB-2300004 - Thalidomide BMS - Patient Card.pdf

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EDM Updated on 15 February 2024

File name

2015-GB-2300010 - Thalidomide BMS - Pharmacy Registration Form.pdf

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EDM Updated on 15 February 2024

File name

2015-GB-2300009 - Thalidomide BMS - Male RAF.pdf

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EDM Updated on 15 February 2024

File name

2015-GB-2300014 - Thalidomide BMS - WCBP RAF.pdf

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EDM Updated on 15 February 2024

File name

2015-GB-2300015- Thalidomide BMS - WNCP RAF.pdf

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EDM Updated on 15 February 2024

File name

Thalidomide BMS - Complete Healthcare Professionals' Information Pack for Ireland.pdf

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EDM Updated on 15 February 2024

File name

Thalidomide BMS - Healthcare Professionals' Information Pack for Prescribers - Ireland.pdf

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EDM Updated on 15 February 2024

File name

Thalidomide BMS - Healthcare Professionals' Information Pack for Pharmacists - Ireland.pdf

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Updated on 04 August 2023

File name

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

File name

ie-pl-13Dec2021.pdf

Reasons for updating

  • Company name change or merger
  • Change to marketing authorisation holder

Updated on 09 August 2022

File name

ie-pl-13Dec2022.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 09 August 2022

File name

ie-spc-13Dec2022.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to restricted prescription (C)

EDM Updated on 29 June 2022

File name

THAL HCPIP Full Pack V6 IRE May2022.pdf

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  • Replace File

EDM Updated on 28 June 2022

File name

Thalidomide HCP Information Pack v5.pdf

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  • Add New Doc

EDM Updated on 10 June 2022

File name

Thalidomide Order Form Ireland.pdf

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  • 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 

EDM Updated on 10 June 2022

File name

Community Pharmacy Dispensing Notification Form.pdf

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  • 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 

EDM Updated on 10 June 2022

File name

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 

EDM Updated on 10 June 2022

File name

Thalidomide Pharmacy Registration 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 

EDM Updated on 10 June 2022

File name

Information for Patients.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 

EDM Updated on 10 June 2022

File name

Patient Information Pocket Card.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 

EDM Updated on 10 June 2022

File name

Prescription Authorisation Form.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 

EDM Updated on 10 June 2022

File name

Male 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 

EDM Updated on 10 June 2022

File name

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 

EDM Updated on 10 June 2022

File name

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

File name

ie-pl-13Dec2021.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Company name change or merger

Updated on 08 November 2021

File name

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

File name

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

File name

ie-pl-16Jul2021.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 06 April 2021

File name

ie-pl-25Mar2021.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 06 April 2021

File name

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

File name

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)

EDM Updated on 11 February 2021

File name

Thalidomide Treatment Initiation Form (TIF) WNCBP_Aug20 v5 IRE.pdf

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EDM Updated on 11 February 2021

File name

Thalidomide Treatment Initiation Form (TIF) WCBP_Aug20 v5 IRE.pdf

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EDM Updated on 11 February 2021

File name

Thalidomide Treatment Initiation Form (TIF) Male_Aug20 v5 IRE.pdf

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EDM Updated on 11 February 2021

File name

Thalidomide Prescription Authorisation Form (PAF)_Aug20 v5 IRE.pdf

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EDM Updated on 11 February 2021

File name

Thalidomide Pharmacy Registration Form_Aug20 v5 IRE.pdf

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EDM Updated on 11 February 2021

File name

Thalidomide Patient Pocket Card_Aug20 v5 IRE.pdf

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EDM Updated on 11 February 2021

File name

Thalidomide Patient's Information Brochure_Aug20 v5 IRE.pdf

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EDM Updated on 11 February 2021

File name

Thalidomide Order Form_Aug20 v5 IRE.pdf

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  • Add New Doc

EDM Updated on 11 February 2021

File name

Thalidomide Community Pharmacy Dispensing Notification Form_Aug20 v5 IRE.pdf

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  • Add New Doc

EDM Updated on 11 February 2021

File name

Thalidomide Information for Healthcare Professional's Brochure_Aug20 v5 IRE.pdf

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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

File name

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

File name

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

File name

THALIDOMIDE PIL IRE V27 15APRIL2019.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 05 April 2019

File name

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

File name

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

Update to sections 4.2 & 6.6

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

Added pulmonary hypertension and viral reactivation.

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

Reporting of suspected adverse reactions: new details of the HPRA included 

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 2: Excipents removed
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 t
hat 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

4.4 Addition of paragraph regarding allergic reactions
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)

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Section 7 - The address of the MA holder has been updated
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

4.4 - Tumour Lysis Syndrome added
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

Name change from Thlaidomide Pharmion to Thalidomide Celgene

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

Section 4.2 Peripheral Neuropathy Guidelines ammendment

Updated on 12 August 2008

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to restricted prescription (C)