Imnovid *
Pharmacy Only: Prescription

  • Company:

    Bristol-Myers Squibb Pharma EEIG
  • Status:

    Updated
  • Legal 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

Updated on 01 March 2023

File name

63ff1bd8a69f1.pdf

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Previous version of SPC reinstated

Legal category:Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Reinstated the SPC

Updated on 01 March 2023

File name

63ff1bd8a69f1.pdf

Reasons for updating

  • Change to section 3 - Pharmaceutical form

Legal category:Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Section 3, update to the capsule size

Updated on 01 March 2023

File name

63ff1b15655b0.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Previous version of PIL reinstated

Free text change information supplied by the pharmaceutical company

Previous PIL reinstated

Updated on 28 February 2023

File name

63fdd41072356.pdf

Reasons for updating

  • 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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients

Legal category:Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

EU 2nd 5 year renewal- minor changes to SmPC sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1, 5.2, 5.3 and 6.1.

Updated on 28 February 2023

File name

63fdd37759b0d.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use

Free text change information supplied by the pharmaceutical company

EU 2nd 5 year renewal- minor changes to PIL sections 2,3 and other sources of information

EDM Updated on 28 June 2022

File name

62bb18e235d96.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 27 June 2022

File name

62b9cfb2aa8f2.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 20 December 2021

File name

Imnovid®▼(pomalidomide) Physician Registration Form_Oct21 v4 IRE_1640020503.pdf

Reasons for updating

  • Replace File

EDM Updated on 20 December 2021

File name

Imnovid®▼(pomalidomide) Physicians Guide to Prescribing_Oct21 v4 IRE_1640020503.pdf

Reasons for updating

  • Replace File

EDM Updated on 20 December 2021

File name

Imnovid®▼(pomalidomide) Community Pharmacy Dispensing Notification Form_Oct21 v4 IRE_1640020503.pdf

Reasons for updating

  • Replace File

EDM Updated on 20 December 2021

File name

Imnovid®▼(pomalidomide) Prescription Authorisation Form (PAF)_Oct21 v4 IRE_1640020503.pdf

Reasons for updating

  • Replace File

EDM Updated on 20 December 2021

File name

Imnovid®▼(pomalidomide) Treatment Initiation Form (TIF) Male_Oct21 v4 IRE_1640020503.pdf

Reasons for updating

  • Replace File

EDM Updated on 20 December 2021

File name

Imnovid®▼(pomalidomide) Treatment Initiation Form (TIF) WCBP_Oct21 v4 IRE_1640020503.pdf

Reasons for updating

  • Replace File

EDM Updated on 20 December 2021

File name

Imnovid®▼(pomalidomide) Pharmacy Registration Form_Oct21 v4 IRE_1640020503.pdf

Reasons for updating

  • Replace File

EDM Updated on 20 December 2021

File name

Imnovid®▼(pomalidomide) Pharmacists Guide to Dispensing_Oct21 v4 IRE_1640020503.pdf

Reasons for updating

  • Replace File

EDM Updated on 20 December 2021

File name

Imnovid®▼(pomalidomide) Treatment Initiation Form (TIF) WNCBP_Oct21 v4 IRE_1640020503.pdf

Reasons for updating

  • Replace File

EDM Updated on 20 December 2021

File name

Imnovid®▼(pomalidomide) Order Form_Oct21 v4 IRE_1640020503.pdf

Reasons for updating

  • Replace File

EDM Updated on 20 December 2021

File name

Imnovid®▼(pomalidomide) Adverse Event Form_Oct21 v4 IRE_1640020503.pdf

Reasons for updating

  • Replace File

EDM Updated on 20 December 2021

File name

Imnovid®▼(pomalidomide) Pregnancy Report Form_Oct21 v4 IRE_1640020503.pdf

Reasons for updating

  • Replace File

EDM Updated on 20 December 2021

File name

Imnovid®▼(pomalidomide) Pregnancy Outcome Form_Oct21 v4 IRE_1640020503.pdf

Reasons for updating

  • Replace File

EDM Updated on 20 December 2021

File name

Imnovid®▼(pomalidomide) Information for Patients Brochure_Oct21 v4 IRE_1640020503.pdf

Reasons for updating

  • Replace File

EDM Updated on 20 December 2021

File name

Imnovid®▼(pomalidomide) Patient Information Pocket Card_Oct21 v4 IRE_1640020503.pdf

Reasons for updating

  • Replace File

EDM Updated on 20 December 2021

File name

Imnovid®▼(pomalidomide) Information for Healthcare Professionals Brochure_Oct21 v4 IRE_1640020257.pdf

Reasons for updating

  • Replace File

Updated on 19 December 2021

File name

ie-spc-9Dec2021_1639951987.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

SmPC section 4.8 – Inclusion of Solid organ transplant rejection in Table 9

Updated on 19 December 2021

File name

ie-pl-9Dec2021_1639951930.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Section 4, the inclusion of solid organ transplant rejection and amend the wording “such as heart and liver” to “such as heart or liver” for clarity

Updated on 04 November 2021

File name

ie-combined-18Oct2021_1636061256.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Free text change information supplied by the pharmaceutical company

Update to the current QP address for Celgene Distribution B.V.

Updated on 22 October 2021

File name

ie-pl-11Oct2021_1634862514.pdf

Reasons for updating

  • Change to other sources of information section

Free text change information supplied by the pharmaceutical company

The change is an update of the Labelling and Package Leaflet to introduce a QR code and URL. The QR code and URL provide access to a website with the most recently approved Package Leaflet (Annex IIIB).

Updated on 01 September 2021

File name

ie-spc-10Aug2021_1630500764.pdf

Reasons for updating

  • Change to section 3 - Pharmaceutical form

Legal category:Product subject to restricted prescription (C)

Updated on 14 July 2021

File name

ie-spc-24Jun2021_1626297725.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to restricted prescription (C)

Updated on 05 July 2021

File name

ie-pl-24Jun2021_1625494521.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to marketing authorisation holder

Updated on 05 July 2021

File name

ie-spc-24Jun2021_1625494467.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to MA holder contact details

Legal category:Product subject to restricted prescription (C)

EDM Updated on 11 February 2021

File name

Imnovid®▼(pomalidomide) Information for Patients Brochure_Dec20 v3 IRE_1613056784.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 11 February 2021

File name

Imnovid®▼(pomalidomide) Patient Information Pocket Card_Dec20 v3 IRE_1613056784.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 11 February 2021

File name

Imnovid®▼(pomalidomide) Pregnancy Outcome Form_Dec20 v3 IRE_1613056671.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 11 February 2021

File name

Imnovid®▼(pomalidomide) Pregnancy Report Form_Dec20 v3 IRE_1613056671.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 11 February 2021

File name

Imnovid®▼(pomalidomide) Adverse Event Form_Dec20 v3 IRE_1613056671.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 11 February 2021

File name

Imnovid®▼(pomalidomide) Order Form_Dec20 v3 IRE_1613056377.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 11 February 2021

File name

Imnovid®▼(pomalidomide) Pharmacists Guide to Dispensing_Dec20 v3 IRE_1613056377.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 11 February 2021

File name

Imnovid®▼(pomalidomide) Pharmacy Registration Form_Dec20 v3 IRE_1613056376.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 11 February 2021

File name

Imnovid®▼(pomalidomide) Treatment Initiation Form (TIF) WNCBP_Dec20 v3 IRE_1613056134.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 11 February 2021

File name

Imnovid®▼(pomalidomide) Treatment Initiation Form (TIF) WCBP_Dec20 v3 IRE_1613056134.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 11 February 2021

File name

Imnovid®▼(pomalidomide) Treatment Initiation Form (TIF) Male_Dec20 v3 IRE_1613056134.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 11 February 2021

File name

Imnovid®▼(pomalidomide) Prescription Authorisation Form (PAF)_Dec20 v3 IRE_1613056134.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 11 February 2021

File name

Imnovid®▼(pomalidomide) Community Pharmacy Dispensing Notification Form_Dec20 v3 IRE_1613055507.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 11 February 2021

File name

Imnovid®▼(pomalidomide) Physicians Guide to Prescribing_Dec20 v3 IRE_1613055507.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 11 February 2021

File name

Imnovid®▼(pomalidomide) Physician Registration Form_Dec20 v3 IRE_1613055507.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 11 February 2021

File name

Imnovid®▼(pomalidomide) Information for Healthcare Professionals Brochure_Dec20 v3 IRE_1613055139.pdf

Reasons for updating

  • Add New Doc

Updated on 20 November 2020

File name

ie-spc-clean_1605897705.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Legal category:Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Change to section 4.2 (posology and method of administration): within paediatric population section, wording referring to studies in children aged 4 to 18 years with recurrent or progressive brain tumours has been updated.

Change to section 4.8 (undesirable effects): within the post-marketing adverse reactions section, wording has been added with regards to the definition of adverse reactions frequencies. Also, a new paediatric population section has been added to mention adverse reactions reported in paediatric patients (aged 4 to 18 years) with recurrent or progressive brain tumours.

Change to section 5.1 (pharmacodynamic properties): new paediatric population section added.

Change to section 5.2 (pharmacokinetic properties): new information has been added to the paediatric population section.

 

Updated on 11 November 2020

File name

ie-spc-clean_1605113109.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

In section 4.4 (Special warnings and precautions for use), inclusion of new ADR Progressive multifocal leukoencephalopathy (PML).

Updated on 11 November 2020

File name

ie-pl-clean_1605112995.pdf

Reasons for updating

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

Updated on 10 June 2020

File name

ie-spc-3Jun2020_1591795490.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 10 June 2020

File name

ie-pl-3Jun2020_1591795391.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects

Updated on 21 May 2019

File name

IMNOVID PIL IRE V18.0 13May2019_1558444855.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 - dose and frequency
  • Change to section 3 - how to take/use
  • 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

IMNOVID SPC IRE V18.0 13May2019_1558444276.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - 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 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 03 April 2019

File name

Imnovid PIL IRE v17 25March2019_1554297788.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 15 October 2018

File name

IE Clean SPC_1539600321.pdf

Reasons for updating

  • Change to section 9 - Date of first authorisation/renewal of the authorisation

Legal category:Product subject to restricted prescription (C)

Updated on 11 October 2018

File name

IE PIL Clean_1539250744.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 11 October 2018

File name

IE SPC Clean_1539250678.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 02 August 2018

File name

IE Clean PIL_1533207198.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 02 August 2018

File name

Imnovid SmPC IE - v14_1533199277.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change from individual to joint SPC

Legal category:Product subject to restricted prescription (C)

Updated on 18 May 2018

File name

Pomalidomide SmPC Clean v13 - 1mg.docx

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 - how to report a side effect

Legal category:Product subject to restricted prescription (C)

Updated on 09 May 2018

File name

Imnovid PIL v13.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 27 September 2016

Reasons for updating

  • New SPC for new product

Legal category:Product subject to restricted prescription (C)

Updated on 27 September 2016

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 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, 4.4 and 10.

Updated on 23 September 2016

File name

PIL_15847_80.pdf

Reasons for updating

  • New PIL for new product

Updated on 23 September 2016

Reasons for updating

  • Change to, or new use for medicine
  • Change to date of revision

Updated on 16 August 2016

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties

Legal category:Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company



Update of sections 4.2, 4.9 and 5.2 to reflect clinical data based on meta-analysis of two renal impairment studies (CC-4047-MM-008 and CC-4047-MM-013)

Updated on 11 August 2016

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 18 July 2016

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

Legal category:Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company



Update of sections 4.2 and 5.2 to reflect clinical data from a hepatic impairment study (CC-4047-CP-009) on pomalidomide exposure in subjects with hepatic impairment. Update of sections 5.2 to reflect data from study

CC-4047-CP-011 on the effect of food, smoking and elderly age on pomalidomide exposure. Update of sections 4.2, 4.5 and 5.2 to reflect data from study CC-4047-CP-012 on co-administration of pomalidomide and CYP1A2 inhibitors.

Updated on 14 July 2016

Reasons for updating

  • Change to dosage and administration

Updated on 06 June 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic 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

Update to sections 4.4, 4.8, 5.1 and 10.

Updated on 02 June 2016

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 07 December 2015

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

Update of section4.4 to specify that the arterial thrombotic events of myocardial infarction and cerebrovascular accident can occur with pomalidomide in combination with dexamethasone and section 4.8 updated accordingly.

Scientific conclusions and grounds recommending the variation to the terms of the Marketing Authorisation

Updated on 03 December 2015

Reasons for updating

  • Change to side-effects

Updated on 12 June 2015

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data

Legal category:Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company



4.4          Special warnings and precautions for use:

Significant cardiac dysfunction – Addition of cardiac failure events and monitoring recommendations.

Allergic reaction – Angioedema and rash warnings included

Interstitial lung disease (ILD) – Section added

Hepatic Disorders – Section added

 

4.8          Undesirable effects:

Tabulated list of adverse reactions – *post marketing data added,

Metabolism and nutrition disorders - Hyperuricaemia* added as common adverse reaction

Cardiac disorders – Added to table (Cardiac failure*, Atrial fibrillation*)

Immune system disorders – Added to table (Angioedema*, Urticaria*)

Respiratory, thoracic and mediastinal disorders - Interstitial lung disease* added as common adverse reaction

Hepatobiliary disorders - Hepatitis* added as uncommon AR

Investigations - Blood uric acid increased* added as AR

* Identified from post marketing data, with frequencies based on clinical trial data – Added

 

5.3          Preclinical safety data

Repeat-dose toxicology studies – Change to wording

Updated on 08 June 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to dosage and administration

Updated on 07 January 2015

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



Section 4.8: post marketing experience of pancytopenia & tumour lysis syndrome included

 

Updated on 29 December 2014

Reasons for updating

  • Change to side-effects

Updated on 08 December 2014

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

Epistaxis has been added as an AE in section 4.8 of the SmPC and section 4 of the PIL. 

Updated on 04 December 2014

Reasons for updating

  • Change to side-effects

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

Individual SmPC from previously combined one

Updated on 15 October 2014

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 16 September 2014

Reasons for updating

  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.3 - Shelf life

Legal category:Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Section 5.2 Addition to the PK data section.  Final paragraph labelled 'Population Pharmacokinetics'
Section 6.3 Shelf life – Altered from 30 months to 3 years

Updated on 03 September 2014

Reasons for updating

  • Change to date of revision

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)

Free text change information supplied by the pharmaceutical company

HPRA details added

Updated on 24 July 2014

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 30 September 2013

Reasons for updating

  • New SPC for new product

Legal category:Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 24 September 2013

Reasons for updating

  • New PIL for new product