Utrogestan® Vaginal 200 mg Vaginal Capsules, soft * 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
When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 20 October 2021
File name
pl-utrogestan-vaginal-200mg_1634720935.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - dose and frequency
- Change to section 3 - how to take/use
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
to register an additional indication “Prevention of a premature singleton birth in women at risk, with a short cervical length of ≤25 mm measured between weeks 16 and 24 of pregnancy (weeks 18 and 26 of amenorrhoea).”
Updated on 28 April 2021
File name
spc-utrogestan-vaginal-200mg_1619613517.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 02 November 2020
File name
Utrogestan® Vaginal 200 mg PIL_1604329989.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 30 October 2020
File name
ie-mockup-pl-utro-200mg- 2020-10-27 Optimized_1603898854.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 28 October 2020
File name
ie-mockup-pl-utro-200mg- 2020-10-27 Optimized_1603898854.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 21 September 2020
File name
PIL- Utrogestan Vaginal 200 mg Vaginal Capsules, soft_1600686119.pdf
Reasons for updating
- New PIL for medicines.ie
Updated on 21 September 2020
File name
SPC-Utrogestan Vaginal 200 mg Vaginal Capsules, soft_1600686073.pdf
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 21 September 2020
File name
ie-spc-Utrogestan Vaginal 200 mg Vaginal Capsules, soft_1600685999.pdf
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 21 September 2020
File name
PIL- Utrogestan Vaginal 200 mg Vaginal Capsules, soft_1600685732.pdf
Reasons for updating
- Previous version of PIL reinstated
Free text change information supplied by the pharmaceutical company
File name upadated
Updated on 27 August 2020
File name
ie-mockup-pl-utro-200mg 202 0-01-15_1598528471.pdf
Reasons for updating
- New PIL for new product
Updated on 27 August 2020
File name
ie-spc-utrogestan-vaginal-200mg-2020-01-15_1598528423.pdf
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 27 August 2020
File name
ie-spc-utrogestan-vaginal-200mg-2020-01-15_1598528378.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)