Distaclor 250mg Granules for Oral Suspension
*Company:
Flynn Pharma 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 23 May 2024
File name
ie-spc-250mg-oralsuspension-cl.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Sections 4.4 and 4.8 have been updated with information following reports of neurotoxicity being identified in association with cephalosporin treatment.
Updated on 23 May 2024
File name
ie-spc-250mg-oralsuspension-cl.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Sections 4.4 and 4.8 have been updated with information following reports of neurotoxicity being identified in association with cephalosporin treatment.
Updated on 23 May 2024
File name
2024-05-22_ie-pl-oralsuspension-cl.pdf
Reasons for updating
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Updated with information following reports of neurotoxicity being identified in association with cephalosporin treatment.
Updated on 24 June 2022
File name
SmPC 250mg OS 2022 06 23.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
MAH address change
Updated on 24 June 2022
File name
PIL mockup OS 2022 06 23.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Free text change information supplied by the pharmaceutical company
MAH address change
Updated on 03 March 2021
File name
Distaclor 250mg suspensionSmPC.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
To confirm that as there is less than 1mmol of sodium per dose; the medicine is considered essentially sodium free
Updated on 03 March 2021
File name
Distaclor Suspension PIL 2021 03 02.pdf
Reasons for updating
- Change to section 2 - excipient warnings
Free text change information supplied by the pharmaceutical company
To confirm that as there is less than 1mmol of sodium per dose; the medicine is considered essentially sodium free.
Updated on 03 March 2021
File name
PIL_17393_720.pdf
Reasons for updating
- Change to section 2 - excipient warnings
Free text change information supplied by the pharmaceutical company
To confirm that as there is less than 1mmol of sodium per dose; the medicine is considered essentially sodium free
Updated on 19 January 2021
File name
Distaclor SmPC 250mg suspension 2018.pdf
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 12 March 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 12 March 2018
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
Updated on 12 March 2018
Reasons for updating
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Updated on 28 February 2018
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 28 February 2018
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Free text change information supplied by the pharmaceutical company
Updated on 05 February 2018
File name
PIL_17393_720.pdf
Reasons for updating
- New PIL for new product
Updated on 13 July 2012
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 13 July 2012
Reasons for updating
- New SPC for medicines.ie
Free text change information supplied by the pharmaceutical company
Flynn Pharma Ltd
Address:
5th Floor, 40 Mespil Road, Dublin 4, IRELAND, D04 C2N4Medical Information E-mail:
medinfo@flynnpharma.comMedical Information Direct Line:
+44 (0)1438 727822