Frovex
*Company:
A. Menarini Pharmaceuticals 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 14 July 2021
File name
Frovex SPC Clean Approved June 21.pdf
Reasons for updating
- 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 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- 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 4.4 - Excipient warnings updated
Section 4.8 - HPRA reporting details updated
Section 6.3 - Details on bottle pack deleted
Section 6.4 - Details on bottle pack deleted
Section 6.5 - Bottle pack deleted and blister pack details updated
Section 10 - Date or revision updated
Updated on 14 July 2021
File name
Frovex PIL Clean Approved June 21.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
- Change to other sources of information section
Free text change information supplied by the pharmaceutical company
Section 2 - Sodium excipient warning added
Section 4 - HPRA reporting details updated
Section 5 - How to store - details on bottle pack deleted
Section 6 - details on blister packs updated
Section 6 - Date of revision updated
Changes to other information - product names in other member states updated
Updated on 01 August 2019
File name
PIL_7922_985.pdf
Reasons for updating
- XPIL Created
Updated on 01 August 2019
File name
ie-spc Frovex approved 14-8-17 clean.pdf
Reasons for updating
- File format updated to PDF
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
File format updated to pdf
Updated on 02 May 2019
File name
PIL_7922_985.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 24 August 2017
File name
PIL_7922_985.pdf
Reasons for updating
- New PIL for new product
Updated on 24 August 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 24 August 2017
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
- Improved presentation of SPC
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 24 August 2017
Reasons for updating
- Improved presentation of PIL
Updated on 18 December 2014
Reasons for updating
- Change of contraindications
- Change to storage instructions
- Addition of information on reporting a side effect.
Updated on 04 December 2014
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
- Change to section 6.4 - Special precautions for storage
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 8 - MA number
- 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
Administrative amendments (to align to the current QRD template)
Sections 2, 3, 4.1, 4.2, 4.3, 4.5, 4.6, 5.2, 6.1, 6.4, 6.6, 8.
Section 4.4 Special warnings and precautions for use
Warning on hypersensitivity added.
Section 4.8 Undesirable effects
Adverse reactions collected in the post-marketing experience - hypersensitivity reactions (including cutaneous disorders, angioedema and anaphylaxis); myocardial infarction and arteriospasm coronary added under ‘not known’ category.
Reporting of side-effects details added.
Section 10 Date of revision of the text
Updated to November 2014
Updated on 04 December 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
- Change to improve clarity and readability
Updated on 17 December 2013
Reasons for updating
- Change to date of revision
Updated on 17 September 2009
Reasons for updating
- Addition of manufacturer
Updated on 18 November 2008
Reasons for updating
- Change to side-effects
Updated on 19 August 2008
Reasons for updating
- 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
Update to section 4.8 - adverse event table
Updated on 08 November 2007
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.9 - Overdose
- Change to section 6.1 - List of excipients
- Change to section 9 - Date of renewal of authorisation
- 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 2 – Include excipient details for lactose
Sections 4.4 - Update warning on prolonged use of painkillers for headaches, add reference to lactose.
Section 4.9 – Update information on overdose
Section 6.1 – Update details for the film coat (Macrogel 3000)
Sections 9 and 10 – Update date of renewal and revision of the text
Updated on 08 November 2007
Reasons for updating
- Change due to user-testing of patient information
- Change due to harmonisation of patient information leaflet
Updated on 20 March 2007
Reasons for updating
- Change to name of manufacturer
Updated on 09 May 2006
Reasons for updating
- Change of manufacturer
Updated on 29 March 2005
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 10 August 2004
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 05 August 2004
Reasons for updating
- New PIL for new product