Imnovid
- Name:
Imnovid
- Company:
Celgene Ltd
- Active Ingredients:
- Legal Category:
Product subject to restricted prescription (C)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 11/11/20

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Celgene Ltd

Company Products
Medicine Name | Active Ingredients |
---|---|
Medicine Name Abraxane | Active Ingredients Paclitaxel Albumin |
Medicine Name Imnovid | Active Ingredients Pomalidomide |
Medicine Name Thalidomide | Active Ingredients Thalidomide |
Medicine Name Vidaza | Active Ingredients azacitidine |
When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 20 November 2020 SPC
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 SPC
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 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 10 June 2020 SPC
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 PIL
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
Updated on 21 May 2019 PIL
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 SPC
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 3 April 2019 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 15 October 2018 SPC
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 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 11 October 2018 SPC
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 2 August 2018 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 2 August 2018 SPC
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 SPC
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 9 May 2018 PIL
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 SPC
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 27 September 2016 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to restricted prescription (C)
Updated on 23 September 2016 PIL
Reasons for updating
- New PIL for new product
Updated on 23 September 2016 PIL
Reasons for updating
- Change to, or new use for medicine
- Change to date of revision
Updated on 16 August 2016 SPC
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 PIL
Reasons for updating
- Change to warnings or special precautions for use
Updated on 18 July 2016 SPC
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 PIL
Reasons for updating
- Change to dosage and administration
Updated on 6 June 2016 SPC
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 2 June 2016 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 7 December 2015 SPC
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 3 December 2015 PIL
Reasons for updating
- Change to side-effects
Updated on 12 June 2015 SPC
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 8 June 2015 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to dosage and administration
Updated on 7 January 2015 SPC
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 PIL
Reasons for updating
- Change to side-effects
Updated on 8 December 2014 SPC
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 4 December 2014 PIL
Reasons for updating
- Change to side-effects
Updated on 26 November 2014 SPC
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 PIL
Reasons for updating
- Addition of information on reporting a side effect.
Updated on 16 September 2014 SPC
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 3 September 2014 PIL
Reasons for updating
- Change to date of revision
Updated on 30 July 2014 SPC
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 PIL
Reasons for updating
- Addition of information on reporting a side effect.
Updated on 30 September 2013 SPC
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 PIL
Reasons for updating
- New PIL for new product