Quofenix 300 mg powder for concentrate for solution for infusion
*Company:
A. Menarini Pharmaceuticals Ireland LtdStatus:
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 30 August 2024
File name
Quofenix 300mg Vials IE SmPC clean renewal approved Aug 24.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Renewal application approval - black triangle removal
Updated on 30 August 2024
File name
Quofenix 300mg Vials UKNI IE PIL clean renewal approved Aug 24.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Removal of Black Inverted Triangle
Updated on 06 March 2024
File name
ie-smpc Quofenix powder for solution Clean Approved Feb 24.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Change in shelf life from 48 to 60 months
Updated on 05 March 2024
File name
ie-smpc Quofenix powder for solution Clean Approved March 24.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Shelf life extension from 4 to 5 years.
Updated on 09 January 2023
File name
ie-uk-pl powder for solution Clean - UKNI IE Combined June 21.pdf
Reasons for updating
- Individual PILs superseded by joint PIL
Free text change information supplied by the pharmaceutical company
Individual PILs superseded by joint PIL
Updated on 09 November 2022
File name
ie-smpc Quofenix powder for solution Clean Approved Feb 22.pdf
Reasons for updating
- Individual PILs superseded by joint PIL
Free text change information supplied by the pharmaceutical company
Joint NI and IE PIL created due to Brexit.
Updated on 09 March 2022
File name
ie-smpc Quofenix powder for solution Clean Approved Feb 22.pdf
Reasons for updating
- Change to section 5.3 - Preclinical safety data
- Change to section 6.6 - Special precautions for disposal and other handling
- 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
5.3 and 6.6 - Information on Environmental risk added
Section 10 - Date of revision updated
Updated on 07 April 2021
File name
ie-smpc Quofenix powder for solution March 2021.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic 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
Section 4.1 - Addition of new indication - community-acquired pneumonia (CAP)
Section 4.2 - New information added for CAP
Section 4.4 - Limitations of the clinical data section updated to include information on CAP
Section 4.8 - New information added for CAP and frequencies updated
Section 5.1 - Section updated with new info on CAP
Section 5.2 - New information added for distribution
Section 10 - Date of revision updated
Updated on 07 April 2021
File name
ie-PIL Powder for Solution March 2021.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Change to section 1 - Addition of new Indication - Pneumonia
Change to section 3 - How to use Quofenix - new details added for Pneumonia
Change to section 4 - Section updated with new and updated information around frequencies
Change to section 4 - Date of revision updated
Updated on 03 December 2020
File name
ie-pl powder for solution Clean 09-11-20.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
The changes relate to the requested actions following the PRAC recommendation concerning the signal of “heart valve regurgitation, cervical artery dissection and aortic aneurysm and dissection” associated with Fluoroquinolones intake.
The following sections are updated:
2. What you need to know before you take Quofenix
Warnings and precautions
…Talk to your doctor or pharmacist or nurse before taking Quofenix if:
4. Possible side effects
Updated on 03 December 2020
File name
ie-smpc Quofenix powder for solution Clean 09-11-20.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
The changes relate to the requested actions following the PRAC recommendation concerning the signal of “heart valve regurgitation, cervical artery dissection and aortic aneurysm and dissection” associated with Fluoroquinolones intake.
The following sections are updated:
Section 4.4 Special warnings and precautions for use
[..]
Aortic dissection and aneurysm, and heart valve regurgitation/incompetence
Further information added.
Section 4.8 Undesirable effects
Cardiac disorders**
Vascular disorders**
** Cases of aortic aneurysm and dissection, sometimes complicated by rupture (including fatal ones), and of regurgitation/incompetence of any of the heart valves have been reported in patients receiving fluoroquinolones (see section 4.4).
Updated on 28 May 2020
File name
ie-smpc Quofenix powder for solution 16-12-19.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 28 May 2020
File name
ie-pl powder for solution 16-12-19.pdf
Reasons for updating
- New PIL for new product