Adcortyl Intra-articular / Intradermal Injection 10mg/ml Suspension for Injection, 5ml
*Company:
Bristol-Myers Squibb Pharmaceuticals ucStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 30 January 2024
File name
20240129-adcortyl-pil-ie-clean-ws.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 30 January 2024
File name
20240129-adcortyl-spc-ie-clean-ws.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 29 April 2022
File name
ie-pl-non-annotated.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 24 June 2021
File name
adcortyl-spc-clean.pdf
Reasons for updating
- 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 medical prescription which may not be renewed (A)
Updated on 24 June 2021
File name
adcortyl-pil-clean.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 28 May 2020
File name
Adcortyl-HA-Approved-PIL.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 07 August 2018
File name
2018 04 ie-adcortyl-1ml-5ml-pil-clean.pdf
Reasons for updating
- New PIL for new product
Updated on 07 August 2018
File name
2018 04 ie-spc-adcortyl-5ml-clean.pdf
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 December 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 December 2017
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 medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Change of name and address of MAH (Previous details: BMS Pharmaceuticals Ltd, Swords, Dublin).
Updated on 06 December 2017
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 of name and address of MAH (Previous details: BMS Pharmaceuticals Ltd, Swords, Dublin).
Updated on 06 April 2017
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
- Change to section 2 - Qualitative and quantitative composition
- 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Note that the changes to section 4.4 and 4.5 are in line with PRAC recommendation Nov 2016.
Updated on 06 April 2017
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
- Change to section 2 - Qualitative and quantitative composition
- 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
Free text change information supplied by the pharmaceutical company
Note that the changes to section 4.4 and 4.5 are in line with PRAC recommendation Nov 2016.
Updated on 01 April 2016
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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 medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In section 4.8 (undesirable effects) added the frequency of the ADRs and updated IMB to HPRA
Updated on 01 April 2016
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 4.8 (undesirable effects) added the frequency of the ADRs and updated IMB to HPRA
Updated on 20 June 2014
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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
PRAC recommendation - update to include 'post menopausal women'.
Updated on 20 June 2014
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
Free text change information supplied by the pharmaceutical company
PRAC recommendation - update to include 'post menopausal women'.
Updated on 07 February 2014
Reasons for updating
- Change to section 6.4 - Special precautions for storage
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
6.4 Special precautions for storage
Do not store above 25°C.
Do not freeze. Do not freeze or refrigerate. Protect from light.
10. DATE OF (PARTIAL) REVISION OF THE TEXT
August 2011February 2013
Do not store above 25°C.
10. DATE OF (PARTIAL) REVISION OF THE TEXT
Updated on 07 February 2014
Reasons for updating
- Change to section 6.4 - Special precautions for storage
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
6.4 Special precautions for storage
Do not store above 25°C.
Do not freeze. Do not freeze or refrigerate. Protect from light.
10. DATE OF (PARTIAL) REVISION OF THE TEXT
August 2011February 2013
Do not store above 25°C.
10. DATE OF (PARTIAL) REVISION OF THE TEXT
Updated on 12 July 2012
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Improve electronic presentation
Updated on 12 July 2012
Reasons for updating
- Improved electronic presentation
Free text change information supplied by the pharmaceutical company
Improve electronic presentation
Updated on 29 September 2011
Reasons for updating
- New individual SPC (was previously included in combined SPC)
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
None provided
Updated on 29 September 2011
Reasons for updating
- New individual SPC (was previously included in combined SPC)
Free text change information supplied by the pharmaceutical company
None provided