Testogel 16.2mg/g Gel
*Company:
Besins Healthcare (UK) LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 20 October 2022
File name
ie-pl-testogel-16.2mg-2022-09-01.pdf
Reasons for updating
- Change to name of manufacturer
Updated on 19 August 2022
File name
uk-ie-pl-testogel-16.2mg-2022-05-23.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 07 June 2021
File name
testogel-16.2mg- PIL.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 07 June 2021
File name
testogel-16.2mg -SmPC.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 29 January 2021
File name
Testogel-16.2mg- SmPC.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:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
PRAC recommendation to revise and update safety precautionary warning content on SPCs and Patient Information Leaflets for Testosterone. The updates relate to “Clotting disorders / VTE” and flammability warning wording for excipient, ethanol.
Updated on 29 January 2021
File name
Testogel-16.2mg- leaflet.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - driving and using machines
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
PRAC recommendation to revise and update safety precautionary warning content on SPCs and Patient Information Leaflets for Testosterone. The updates relate to “Clotting disorders / VTE” and flammability warning wording for excipient, ethanol.
Updated on 19 August 2020
File name
Testogel-16.2mg- leaflet.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
Changes notified are as follows:
- Change in details of the local representative for the UK (distributor) from 1st Floor, 28 Poland Street, London, W1F 8QN to Lion Court, 25 Procter Street Holborn, London, WC1V 6NY
- Update date of revision
Updated on 27 July 2018
File name
ie-spc-testogel-16.2mg-2018-06-24.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
PRAC (PSUSA/00002908/201512) – Thrombosis risk; addition to SmPC section 4.4 the following warning:
“Testosterone should be used with caution in patients with thrombophilia, as there have been post-marketing reports of thrombotic events in these patients during testosterone therapy.”
Updated on 27 February 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 February 2018
File name
PIL_17421_571.pdf
Reasons for updating
- New PIL for new product