Oestrogel Pump-Pack 750 micrograms/actuation Gel
*Company:
Besins Healthcare (UK) 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 25 June 2024
File name
ie-pil-oestrogel-3_0-2024-06-25.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
- Joint PIL superseded by individual PILs
Updated on 25 January 2024
File name
ie-pil-oestrogel-1_0-2024-01-16.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Updated on 25 January 2024
File name
ie-spc-oestrogel-1_0-2024-01-16.pdf
Reasons for updating
- 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 10 March 2023
File name
ie-spc-oestrogel-2023-03-09.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
ie-pil-oestrogel-2023-03-09.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
ie-pl-oestrogel-2022-12-21.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 21 December 2022
File name
ie-spc-oestrogel-2022-12-21.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
ie-pl-oestrogel-2022-08-24.pdf
Reasons for updating
- Change to name of manufacturer
Updated on 19 August 2022
File name
ie-spc-oestrogel-2022-02-04.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
uk-pl-oestrogel-2022-04-06.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.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.pdf
Reasons for updating
- New PIL for new product
Updated on 28 January 2021
File name
Oestrogel Pump SmPC.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)