Otezla 10mg, 20mg, 30mg
- Name:
Otezla 10mg, 20mg, 30mg
- Company:
Celgene Ltd
- Active Ingredients:
- 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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Celgene Ltd
Company Products
| Medicine Name | Active 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 |
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
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
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
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
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
Updated on 20 January 2015 PIL
Reasons for updating
- New PIL for new product