Oestrogel Pump-Pack 750 micrograms/actuation Gel *
Pharmacy Only: Prescription

  • Company:

    Besins Healthcare (UK) Ltd
  • Status:

    No Recent Update
  • Legal 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 10 March 2023

File name

640b593f1b710.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 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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

Addition of Ethanol, flammability warning & ALT elevations

Update to HPRA adverse event reporting

Updated on 10 March 2023

File name

640b58ef1d2db.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 3 - how to take/use

Updated on 21 December 2022

File name

63a2f7dbe7c14.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 21 December 2022

File name

63a2f6e74ae36.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 31 August 2022

File name

630f43b1cd26b.pdf

Reasons for updating

  • Change to name of manufacturer

Updated on 19 August 2022

File name

62ff8d358416e.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

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Minor corrections

Updated on 19 August 2022

File name

62ff8cdf3a938.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Free text change information supplied by the pharmaceutical company

Change to UK MAH address

Updated on 21 September 2021

File name

spc-oesrogel_1632254765.pdf

Reasons for updating

  • 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 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 28 January 2021

File name

Oestrogel Pump Leaflet_1611836667.pdf

Reasons for updating

  • New PIL for new product

Updated on 28 January 2021

File name

Oestrogel Pump SmPC_1611836531.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)