Neupro 4 mg/24hr, 6 mg/24hr, 8 mg/24hr Transdermal Patch
*Company:
UCB (Pharma) Ireland LimitedStatus:
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 07 August 2024
File name
ie-spc-neupro-tdp-4,6,8mg24hr-en.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- 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
Changing the pharmacode position and size on the Neupro frontside primary packaging; Replacement of NIP by a carton packaging & change of the booklet to a standard P
Updated on 07 August 2024
File name
ie-pil-neupro-tdp-4,6,8mg24hr.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Changing the pharmacode position and size on the Neupro frontside primary packaging; Replacement of NIP by a carton packaging & change of the booklet to a standard P
Updated on 15 December 2023
File name
ie-pil-neupro-tdp-4,6,8mg24hr.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 14 December 2023
File name
ie-spc-neupro-tdp-4,6,8mg24hr.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 December 2023
File name
ie-pil-neupro-tdp-4,6,8mg24hr.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 27 January 2021
File name
ie-pil-neupro-tdp-4,6,8mg24hr-en.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Update to section warnings & precautions related to impulse control and other disorders (dopamine dysregulation disorder and dopamine agonist withdrawal syndrome).
Addition of ‘’or nurse’’ in various sections.
Updated on 27 January 2021
File name
ie-spc-neupro-tdp-4,6,8mg24hr-en.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
- 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
Update to section 4.4 related to impulse control and other disorders (dopamine dysregulation disorder and dopamine agonist withdrawal syndrome).
Removal of information for skin adhesion in section 5.1.
Updated on 22 January 2020
File name
3.1 IE PIL - Neupro 4mg, 6mg, 8mg_24h transdermal patch - CLEAN - 21JAN2020.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
To include “Rhabdomyolysis” as undesirable effect with frequency “not known” and widen the scope of an existing undesirable effect “increased CPK” based on new pharmacovigilance data.
Updated on 22 January 2020
File name
3. IE SPC - Neupro 4mg, 6mg, 8mg_24h transdermal patch - CLEAN - 21JAN2020.pdf
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 medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
To include “Rhabdomyolysis” as undesirable effect with frequency “not known” and widen the scope of an existing undesirable effect “increased CPK” based on new pharmacovigilance data.
Updated on 02 August 2018
File name
4 6 8 mg 24 h PIL IE.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 02 August 2018
File name
4 6 8 mg 24h SPC IE.pdf
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 medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Change concerning a linguistic Review - Dropped Head Syndrome and additional changes
Section 4.8 Undesirable effect- Tabulated list of adverse reactions; Section 10- Date of revision of the text
Updated on 17 January 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 January 2018
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Changes were made to the following sections:
Section 4.2: Changes to duration of pressing during the application of the patch.
Section 6.5: amendment to reflect the change of design from cardboard to plastic and to change an existing pack-size.
Updated on 01 December 2017
File name
PIL_14783_537.pdf
Reasons for updating
- New PIL for new product
Updated on 01 December 2017
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - use in children and adolescents
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - driving and using machines
- Change to section 2 - excipient warnings
- Change to section 3 - dose and frequency
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 3 - duration of treatment
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Individual PILs superseded by joint PIL
Updated on 16 October 2017
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 16 October 2017
Reasons for updating
- Change to section 6 - manufacturer
Updated on 26 June 2017
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 23 June 2017
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - what the product looks like and pack contents
Updated on 13 December 2016
Reasons for updating
- Change to other sources of information section
Updated on 15 November 2016
Reasons for updating
- Change to other sources of information section
Updated on 15 March 2016
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 9 - Date of renewal of authorisation
- 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
5.1 Pharmacodynamic properties
Reference to a skin adhesion study has been included.
6.3 Shelf life
The shelf life has increased to 30 months (from 2 years).
6.4 Special precautions for storage
The storage conditions have been updated to “Do not store above 30°C” (previously 25°C).
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
The date of last renewal has been added: 22 January 2016
10. DATE OF REVISION OF THE TEXT
The date of revision has been added: 02/2016
Updated on 10 March 2016
Reasons for updating
- Change to storage instructions
- Change to date of revision
- Change to dosage and administration
Updated on 15 February 2016
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change to side-effects
- Change to information about pregnancy or lactation
- Deletion of a pack size
Updated on 12 February 2016
Reasons for updating
- Addition of separate SPCs covering individual presentations
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 30 June 2015
Reasons for updating
- Change to side-effects
Updated on 25 September 2013
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to improve clarity and readability
Updated on 17 February 2012
Reasons for updating
- Change to instructions about overdose
Updated on 13 May 2011
Reasons for updating
- Change to further information section
Updated on 02 March 2011
Reasons for updating
- Change to warnings or special precautions for use
- Change of special precautions for disposal
Updated on 31 August 2010
Reasons for updating
- New PIL for medicines.ie