We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we'll assume that you are happy to receive all cookies on the medicines.ie website. Find out more

Galderma (U.K) Ltd

Meridien House, 69-71 Clarendon Road, Watford, Hertfordshire, WD17 1DS, UK
Telephone: +44 (0) 1923 208950
Fax: +44 (0) 1923 208998
Summary of Product Characteristics last updated on medicines.ie: 13/07/2017
SPC Mirvaso 3mg/g Gel

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 13/07/2017 and displayed until Current
Reasons for adding or 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
Date of revision of text on the SPC:   31-May-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Section 4.4 - addition of warning regarding laser therapy
Section 4.8 - addition of bradycardia and dizziness
Section 10 - date of revision of the text updated
Updated on 30/01/2017 and displayed until 13/07/2017
Reasons for adding or 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)
Date of revision of text on the SPC:   12-Jan-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Section 4.2 - Change to method of application
Section 4.4 - Information about exacerbation of rosacea
Section 6.5 - Change to packaging formnat
Updated on 19/12/2016 and displayed until 30/01/2017
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   22-Nov-2016
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

To add "pallor at the application site*onto section 4.8
Updated on 15/01/2016 and displayed until 19/12/2016
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   19-Nov-2015
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Addition of hypotension and angioedema as rare adverse events in section 4.8
Updated on 03/08/2015 and displayed until 15/01/2016
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   31-Mar-2015
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 21/01/2015 and displayed until 03/08/2015
Reasons for adding or 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
Date of revision of text on the SPC:   31-Jul-2014
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 12/03/2014 and displayed until 21/01/2015
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

None provided

Document Links

 
  View all medicines
from this company
View Document
Bookmark and Share

Active Ingredients

 
   brimonidine tartrate