Otezla 10mg, 20mg, 30mg

  • Name:

    Otezla 10mg, 20mg, 30mg

  • Company:
    info
  • Active Ingredients:

    Apremilast

  • Legal Category:

    Product subject to restricted prescription (C)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 06/09/19

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Summary of Product Characteristics last updated on medicines.ie: 25/10/2019

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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 Otezla 10mg, 20mg, 30mg Active Ingredients Apremilast
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 25 October 2019 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

In section 6.3, the shelf life has changed from 2 to 3 years

Updated on 6 September 2019 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Removal of Black Inverted Triangle
  • Improved presentation of PIL

Updated on 6 September 2019 SmPC

Reasons for updating

  • Addition of joint SmPC covering all presentations
  • Change to section 6.3 - Shelf life
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • Removal of Black Inverted Triangle
  • Change to improve clarity and readability

Legal category: Product subject to restricted prescription (C)

Updated on 9 August 2019 PIL

Reasons for updating

  • Change to other sources of information section

Updated on 5 April 2019 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 20 March 2019 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 18 January 2019 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 section 4.8 of the SmPC to add the adverse drug reactions angioedema with a frequency unknown and urticaria with an uncommon frequency. 

Update of sections 4.2 & 5.1 of the SmPC to include 5 year CSRs data from the PALACE and ESTEEM program

Updated on 3 January 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 3 January 2019 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 section 4.8 of the SmPC and section 4 of the PIL to add the adverse drug reactions angioedema with a frequency unknown and urticaria with an uncommon frequency. 

Updated on 14 August 2018 PIL

Reasons for updating

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

Updated on 14 August 2018 SmPC

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 9 January 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to restricted prescription (C)

Updated on 9 January 2018 SmPC

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

Addition of new language on diarrhoea, nausea, and vomiting in section 4.4 & 4.8

Updated on 5 January 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 5 January 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 5 January 2017 SmPC

Reasons for updating

  • 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

Revision of the text date updated

Updated on 4 January 2017 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 21 December 2016 SmPC

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 to sections 4.4 and 4.8. Addition of Psychiatric disorders (suicidal ideation and behaviour, and depression).

Updated on 19 December 2016 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 22 July 2016 SmPC

Reasons for updating

  • 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

Update to sections 4.8 and 10.

Updated on 20 July 2016 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 23 February 2016 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

This change impacts section 6.3 of the SPC, changing the shelf-life from 21 to 24 months and there are also a few typographical changes throughout the SPC. 

Updated on 12 February 2016 PIL

Reasons for updating

  • Change to, or new use for medicine

Updated on 11 February 2016 PIL

Reasons for updating

  • Change to, or new use for medicine
  • PIL retired pending re-submission

Updated on 23 January 2015 SmPC

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 20 January 2015 PIL

Reasons for updating

  • New PIL for new product