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