Plenadren 5 mg and 20 mg modified release tablets
*Company:
Takeda Products Ireland LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 25 November 2022
File name
ie-pl-clean-mah-address-update.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
Free text change information supplied by the pharmaceutical company
Section 6: Change in the address of the Marketing Authorisation Holder (MAH), Change of address of the Batch Release Site (BRS)
Updated on 25 November 2022
File name
ie-spc-clean-mah-address-update.pdf
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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 7: Change in the address of the Marketing Authorisation Holder (MAH)
Updated on 21 October 2022
File name
ie-pl-clean-pheochromocytoma-update-13-10-2022.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
Free text change information supplied by the pharmaceutical company
In section 2 - warnings and precautions the following text has been added:
- if you have pheochromocytoma (a rare tumour of the adrenal glands).
In section 6 the following has been updated:
-list of local representatives in section 6 of the Package Leaflet
Changes to other sections are editorial.
Updated on 21 October 2022
File name
ie-spc-clean-pheochromocytoma-update-13-10-2022.pdf
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
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
In section 4.4 - Special warnings and precautions for use, the following warning has been added:
Pheochromocytoma crisis, which can be fatal, has been reported after administration of systemic corticosteroids. Corticosteroids should only be administered to patients with suspected or identified pheochromocytoma after an appropriate risk/benefit evaluation.
Additional changes:
-addition of contact e-mail address for the MAH in section 7 of the SmPC
-list of local representatives in section 6 of the Package Leaflet
Changes in other sections are editorial.
Updated on 29 March 2022
File name
IE-Plenadren-SmPC-clean-20-01-2022.pdf
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
New version of SmPC with corrected date of revision to 20.01.22
Updated on 22 March 2022
File name
IE-Plenadren-PIL-clean-16-03-2022.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Addition of Takeda Pharmaceuticals International AG Ireland Branch as a manufacturer
Updated on 04 February 2022
File name
IE-Plenadren-PIL-25-01-2022.pdf
Reasons for updating
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 04 February 2022
File name
IE-Plenadren-SmPC-25-01-2022.pdf
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 be renewed (B)
Free text change information supplied by the pharmaceutical company
The following changes have been made to the SmPC
In section 7, the MA holder has been updated to:
Takeda Pharmaceuticals International AG Ireland Branch
Block 3 Miesian Plaza
50-58 Baggot Street Lower
Dublin 2
Ireland
Date of revision of the text: 25/01/2022
Updated on 22 February 2021
File name
Plenadren SmPC Ireland May 2018.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 22 February 2021
File name
Plenadren PIL Ireland May 2018.pdf
Reasons for updating
- New PIL for new product