Palladone SR 8 mg capsules
*Company:
Mundipharma Pharmaceuticals Limited - Formerly Napp LaboratoriesStatus:
UpdatedLegal 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 November 2024
File name
Palladone PR capsule 8mg smpc clean.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.9 - Overdose
- Change to section 6.1 - List of excipients
- 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
Type II Worksharing procedure: CCDSv21: DE-H-xxxx-WS-1585
Updated on 07 November 2024
File name
Palladone PR capsule pil clean.pdf
Reasons for updating
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
- Removal of one or more presentations from joint PIL
- Change to date of revision
Free text change information supplied by the pharmaceutical company
Type II worksharing procedure: CCDSv21: DE-H-xxxx-WS-1585
Updated on 07 September 2023
File name
Palladone SR 8 mg prolonged release capsules - SmPC - clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 April 2023
File name
Palladone SR 8 mg prolonged release capsules - SmPC - clean.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
IE MAH Address Change
Updated on 06 April 2023
File name
Palladone SR 2 mg, 4 mg, 8 mg, 16 mg and 24 mg prolonged-release capsules - PIL - clean.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
IE MAH Address Change