Mirvaso 3mg/g Gel * Pharmacy Only: Prescription
Company:
Galderma International S.A.S. c/o Galderma (U.K) Ltd.Status:
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 03 April 2022
File name
20220118 Mirvaso ie-pil-clean_1649019353.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to further information section
- Change to date of revision
Free text change information supplied by the pharmaceutical company
Type IB safety variation approval issued 18Jan2022 by EMA to update the SmPC (the level of propylene glycol has been quantified in section 4.4 - Special warnings and precautions for use) and PIL in line with the Annex, published 22Nov2019 (EMA/CHMP/302620/2017 Rev. 1) to the EC guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ (SANTE-2017-11668). The MAH took the opportunity to update the Package Leaflet with the details of the local representative for the United Kingdom (Northern Ireland) in order to align the PI to the latest QRD template (version 10.2).
Updated on 03 April 2022
File name
20220118 Mirvaso ie-spc-clean_1649018618.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
- Updated inline with QRD template and/or excipient guideline
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Type IB safety variation approval issued 18Jan2022 by EMA to update the SmPC (the level of propylene glycol has been quantified in section 4.4 - Special warnings and precautions for use) and PIL in line with the Annex, published 22Nov2019 (EMA/CHMP/302620/2017 Rev. 1) to the EC guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ (SANTE-2017-11668). The MAH took the opportunity to update the Package Leaflet with the details of the local representative for the United Kingdom (Northern Ireland) in order to align the PI to the latest QRD template (version 10.2).
Updated on 16 September 2020
File name
Mirvaso Leaflet UK & IRE (P26244-6) Sep 20_1600246962.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - dose and frequency
Free text change information supplied by the pharmaceutical company
Various administrative changes
Updated on 10 February 2020
File name
ie-spc-current-Mirvaso-Nov18_1581348253.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
- File format updated to PDF
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 13 July 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 13 July 2017
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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.8 - addition of bradycardia and dizziness
Section 10 - date of revision of the text updated
Updated on 03 July 2017
File name
PIL_15954_409.pdf
Reasons for updating
- New PIL for new product
Updated on 03 July 2017
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
Updated on 13 February 2017
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Updated on 30 January 2017
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.4 - Information about exacerbation of rosacea
Section 6.5 - Change to packaging formnat
Updated on 19 December 2016
Reasons for updating
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 24 November 2016
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 18 January 2016
Reasons for updating
- Change to side-effects
Updated on 15 January 2016
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
Updated on 03 August 2015
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
4.4 Special warnings and precautions for use
Mirvaso should not be applied on irritated skin or open wounds. In case of severe irritation or contact allergy, the treatment with the medicinal product should be discontinued.
Treatment with the medicinal product should start on a small area of the face to test the tolerance.
Erythema and Flushing
The effect of Mirvaso begins to diminish hours after application. In some patients, erythema and flushing were reported to return with greater severity than was present at baseline. Most of the cases were observed within the first 2 weeks of starting the treatment (see section 4.8).
The onset of flushing relative to application of Mirvaso varied, ranging from approximately 30 minutes to several hours (see section 4.8).
In the majority of these cases, erythema and flushing resolved after discontinuation of Mirvaso.
In case worsening of erythema occurs, Mirvaso should be discontinued. Symptomatic measures, such as cooling, NSAID and antihistamines, may help in alleviating symptoms.
Recurrences of aggravated erythema and flushing have been reported after re-administration of Mirvaso. Prior to resuming treatment after temporary discontinuation due to aggravated erythema or flushing, it is advisable to first ensure restoration of the skin barrier function, if necessary, and perform a test application on a small area of the face before full facial application is resumed.
It is important to inform the patient not to exceed the recommended dose and frequency of application: once daily use in a thin layer.
Mirvaso should not be applied close to the eyes.
Updated on 03 August 2015
Reasons for updating
- Change to warnings or special precautions for use
Updated on 21 January 2015
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- 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
6.5 Nature and contents of container
[2g]
Polyethylene (PE)/Aluminium (Al)/ Polyethylene
(PE) laminated plastic tubes with a high density
polyethylene (HDPE) head and polypropylene (PP)
closure.
[10; 30g]
Polyethylene (PE)/Aluminium (Al)/ Polyethylene
(PE) laminated plastic tubes with a high density
polyethylene (HDPE) head and polypropylene (PP)
child resistant closure.
Or
[2g]
Polyethylene (PE)/Copolymer/Aluminium
(Al)/Copolymer/Polyethylene (PE) polyfoil plastic
tubes (kind of laminate) with a high density
polyethylene (HDPE) head and polyethylene (PE)
child resistant closure
[
10 g; 30g]
Polyethylene (PE)/Copolymer/Aluminium
(Al)/Copolymer/Polyethylene (PE) polyfoil plastic
tubes (kind of laminate) with a high density
polyethylene (HDPE) head and polypropylene (PP)
child resistant closure
8. MARKETING AUTHORISATION NUMBER(S)
Polyethylene (PE)/Aluminium (Al)/ Polyethylene
(PE) laminated plastic tubes :
EU/1/13/904/001
EU/1/13/904/002
EU/1/13/904/003
Polyethylene (PE)/Copolymer/Aluminium
(Al)/Copolymer/Polyethylene (PE) polyfoil plastic
tubes :
EU/1/13/904/004
EU/1/13/904/005
EU/1/13/904/006
Updated on 16 January 2015
Reasons for updating
- Addition of information on reporting a side effect.
- Change to date of revision
- Introduction of new pack/pack size
Updated on 12 March 2014
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
Updated on 07 March 2014
Reasons for updating
- New PIL for new product