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
Updated on 01 February 2022
File name
ie-spc-utrogestan-vaginal-200mg-2022-01-18_1643721394.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 01 February 2022
File name
ie-pl-utrogestan-vaginal-200mg-2022-01-18_1643721155.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- 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 - pregnancy, breast feeding and fertility
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
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)