Rectogesic 4 mg/g Rectal Ointment
*Company:
Grünenthal MedsStatus:
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 05 September 2024
File name
Rectogesic 4mg-g Rectal Ointment - PIL - Ireland clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Change in marketing authorisation holder from Kyowa Kirin International to Grunenthal Pharma Ltd., and resulting change to date of revision of the text of Aug 24
Updated on 05 September 2024
File name
Rectogesic 4mg-g Rectal Ointment - SPC - Ireland clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- 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
Market authorisation holder changed from Kyowa Kirin International to Grunenthal Pharma Ltd., with respective update to PA number and date of revision of the text.
Updated on 10 February 2023
File name
Rectogesic 4mg-g Rectal Ointment - PIL - Ireland clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Change to section 4 - Reporting of side effects - where to report a side effect; Date of revision from December 2018 to January 2023
Updated on 14 December 2018
File name
Rectogesic 4mg-g Rectal Ointment PIL IE - Clean (003).pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 14 December 2018
File name
Rectogesic 4mg-g Rectal Ointment SPC IE - Clean (003).pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- 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
Section 7- Marketing Authorisation Holder has been updated to Kyowa Kirin Holdings B.V. Bloemlaan 2, 2132NP Hoofddorp Netherlands
Section 8- Marketing Authorisation Number has been updated to PA2288/001/003
Section 10- Date of (partial) revision of the text changed from May 2016 to Dec 2018
Updated on 01 November 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 November 2016
Reasons for updating
- Change to section 10 - Date of revision of the text
- 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 28 October 2016
File name
PIL_16564_715.pdf
Reasons for updating
- New PIL for new product
Updated on 28 October 2016
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 18 February 2016
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 21 December 2015
Reasons for updating
- New PIL for medicines.ie