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Regaine for Women Extra Strength 5% w/w Scalp Foam Cutaneous Foam

*
Pharmacy Only: Non-prescription

  • Company:

    Kenvue

  • Status:

    No Recent Update

  • Legal Category:

    Supply through pharmacy only

  • Active Ingredient(s):

    Minoxidil

    *Additional information is available within the SPC or upon request to the company

Updated on 24 January 2024

File name

ie-spc v8-regaine for women foam-2443.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 24 January 2024

File name

ie-leaflet-regaine-for-women-foam-2443.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 19 June 2023

File name

ie-pl-proposed-clean-regaine for women foam-2303.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision

Updated on 19 June 2023

File name

ie-spc v7-proposed-clean-regaine for women foam-2303.pdf

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 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 24 February 2023

File name

ie-spc v6 regaine for women foam-2246.pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 24 February 2023

File name

ie-leaflet-regaine-for-women-foam-2246.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 02 February 2023

File name

ie-leaflet-proposed-clean-regaine-for-women-foam-2307.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 07 May 2021

File name

ie-spc v5-clean regaine for women foam - 2144.pdf

Reasons for updating

  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 13 February 2019

File name

ie-pl Regaine for Women Foam RGG02 1888.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 13 February 2019

File name

ie-spc v4 RGG02 1888.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 20 August 2018

File name

ie-pl clean RGG02 1708.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - driving and using machines
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 20 August 2018

File name

ie-spc v3 RGG02 1708.pdf

Reasons for updating

  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 07 March 2017

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 07 March 2017

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Changes made the the text have been highlighted in red, underlined text has been added, and struck through text has been removed:

4.8       Undesirable effects

        [...]

System Organ Class and Frequency

Adverse Drug Reaction

 

Immune system disorders

 

Not known

Allergic reactions including aAngioedema

(with symptoms such as e.g. oedema of lips, mouth, tongue and pharynx, swelling of lips, tongue and oropharynx)

 

Hypersensitivity

(including face oedema, generalised erythema, pruritus generalised, swelling face, and throat tightness)

 

Allergic contact dermatitis

 

        [...]

10.       DATE OF REVISION OF THE TEXT

January 2016January 2017


Updated on 01 March 2017

File name

PIL_16983_78.pdf

Reasons for updating

  • New PIL for new product

Updated on 01 March 2017

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 09 November 2016

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

None provided

Updated on 07 November 2016

Reasons for updating

  • New PIL for new product