Imnovid * Pharmacy Only: Prescription
Company:
Bristol-Myers Squibb Pharma EEIGStatus:
UpdatedLegal 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
File name
62bb18e235d96.pdf
Reasons for updating
- Add New Doc
File name
62b9cfb2aa8f2.pdf
Reasons for updating
- Add New Doc
File name
Imnovid®▼(pomalidomide) Physician Registration Form_Oct21 v4 IRE_1640020503.pdf
Reasons for updating
- Replace File
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Imnovid®▼(pomalidomide) Physicians Guide to Prescribing_Oct21 v4 IRE_1640020503.pdf
Reasons for updating
- Replace File
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Imnovid®▼(pomalidomide) Community Pharmacy Dispensing Notification Form_Oct21 v4 IRE_1640020503.pdf
Reasons for updating
- Replace File
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Imnovid®▼(pomalidomide) Prescription Authorisation Form (PAF)_Oct21 v4 IRE_1640020503.pdf
Reasons for updating
- Replace File
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Imnovid®▼(pomalidomide) Treatment Initiation Form (TIF) Male_Oct21 v4 IRE_1640020503.pdf
Reasons for updating
- Replace File
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Imnovid®▼(pomalidomide) Treatment Initiation Form (TIF) WCBP_Oct21 v4 IRE_1640020503.pdf
Reasons for updating
- Replace File
File name
Imnovid®▼(pomalidomide) Pharmacy Registration Form_Oct21 v4 IRE_1640020503.pdf
Reasons for updating
- Replace File
File name
Imnovid®▼(pomalidomide) Pharmacists Guide to Dispensing_Oct21 v4 IRE_1640020503.pdf
Reasons for updating
- Replace File
File name
Imnovid®▼(pomalidomide) Treatment Initiation Form (TIF) WNCBP_Oct21 v4 IRE_1640020503.pdf
Reasons for updating
- Replace File
File name
Imnovid®▼(pomalidomide) Order Form_Oct21 v4 IRE_1640020503.pdf
Reasons for updating
- Replace File
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Imnovid®▼(pomalidomide) Adverse Event Form_Oct21 v4 IRE_1640020503.pdf
Reasons for updating
- Replace File
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Imnovid®▼(pomalidomide) Pregnancy Report Form_Oct21 v4 IRE_1640020503.pdf
Reasons for updating
- Replace File
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Imnovid®▼(pomalidomide) Pregnancy Outcome Form_Oct21 v4 IRE_1640020503.pdf
Reasons for updating
- Replace File
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Imnovid®▼(pomalidomide) Information for Patients Brochure_Oct21 v4 IRE_1640020503.pdf
Reasons for updating
- Replace File
File name
Imnovid®▼(pomalidomide) Patient Information Pocket Card_Oct21 v4 IRE_1640020503.pdf
Reasons for updating
- Replace File
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)
File name
Imnovid®▼(pomalidomide) Information for Patients Brochure_Dec20 v3 IRE_1613056784.pdf
Reasons for updating
- Add New Doc
File name
Imnovid®▼(pomalidomide) Patient Information Pocket Card_Dec20 v3 IRE_1613056784.pdf
Reasons for updating
- Add New Doc
File name
Imnovid®▼(pomalidomide) Pregnancy Outcome Form_Dec20 v3 IRE_1613056671.pdf
Reasons for updating
- Add New Doc
File name
Imnovid®▼(pomalidomide) Pregnancy Report Form_Dec20 v3 IRE_1613056671.pdf
Reasons for updating
- Add New Doc
File name
Imnovid®▼(pomalidomide) Adverse Event Form_Dec20 v3 IRE_1613056671.pdf
Reasons for updating
- Add New Doc
File name
Imnovid®▼(pomalidomide) Order Form_Dec20 v3 IRE_1613056377.pdf
Reasons for updating
- Add New Doc
File name
Imnovid®▼(pomalidomide) Pharmacists Guide to Dispensing_Dec20 v3 IRE_1613056377.pdf
Reasons for updating
- Add New Doc
File name
Imnovid®▼(pomalidomide) Pharmacy Registration Form_Dec20 v3 IRE_1613056376.pdf
Reasons for updating
- Add New Doc
File name
Imnovid®▼(pomalidomide) Treatment Initiation Form (TIF) WNCBP_Dec20 v3 IRE_1613056134.pdf
Reasons for updating
- Add New Doc
File name
Imnovid®▼(pomalidomide) Treatment Initiation Form (TIF) WCBP_Dec20 v3 IRE_1613056134.pdf
Reasons for updating
- Add New Doc
File name
Imnovid®▼(pomalidomide) Treatment Initiation Form (TIF) Male_Dec20 v3 IRE_1613056134.pdf
Reasons for updating
- Add New Doc
File name
Imnovid®▼(pomalidomide) Prescription Authorisation Form (PAF)_Dec20 v3 IRE_1613056134.pdf
Reasons for updating
- Add New Doc
File name
Imnovid®▼(pomalidomide) Community Pharmacy Dispensing Notification Form_Dec20 v3 IRE_1613055507.pdf
Reasons for updating
- Add New Doc
File name
Imnovid®▼(pomalidomide) Physicians Guide to Prescribing_Dec20 v3 IRE_1613055507.pdf
Reasons for updating
- Add New Doc
File name
Imnovid®▼(pomalidomide) Physician Registration Form_Dec20 v3 IRE_1613055507.pdf
Reasons for updating
- Add New Doc
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
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
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
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
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
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 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
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
Updated on 24 September 2013
Reasons for updating
- New PIL for new product