Imnovid

  • Name:

    Imnovid

  • Company:
    info
  • Active Ingredients:

    Pomalidomide

  • 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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Summary of Product Characteristics last updated on medicines.ie: 20/11/2020
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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Celgene Ltd

Celgene Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name Abraxane Active Ingredients Paclitaxel Albumin
Medicine Name Imnovid Active Ingredients Pomalidomide
Medicine Name Revlimid 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg hard capsules Active Ingredients Lenalidomide
Medicine Name Thalidomide Active Ingredients Thalidomide
Medicine Name Vidaza Active Ingredients azacitidine
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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

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

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

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

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

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

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

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

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

Reasons for updating

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

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

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

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

Reasons for updating

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

Updated on 18 May 2018

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

Update to sections 4.2, 4.4 and 10.

Updated on 27 September 2016

Reasons for updating

  • New SmPC 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

Update to sections 4.4, 4.8, 5.1 and 10.

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

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 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

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

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

Individual SmPC from previously combined one

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 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 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

HPRA details added

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

None provided

Updated on 24 September 2013 PIL

Reasons for updating

  • New PIL for new product