Utrogestan® Vaginal 200 mg Vaginal Capsules, soft
*Company:
Besins Healthcare (UK) LtdStatus:
UpdatedLegal 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 26 March 2024
File name
ie-pl-utrogestan-vaginal-200mg-2_0 - 2024-03-18.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 07 November 2023
File name
ie-pl-utrogestan-vaginal-200mg-1_0 - 2023-11-06.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - dose and frequency
- Change to section 3 - how to take/use
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 07 November 2023
File name
ie-pl-utrogestan-vaginal-200mg-1_0 - 2023-11-06.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - dose and frequency
- Change to section 3 - how to take/use
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 05 October 2023
File name
ie-pl-utrogestan-vaginal-200mg- 2023-10-05.pdf
Reasons for updating
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Change to Section ‘This medicinal product is authorized in the Member States of the EEA under the following names’
Updated on 01 February 2022
File name
ie-spc-utrogestan-vaginal-200mg-2022-01-18.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.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.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.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.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.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.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.pdf
Reasons for updating
- New PIL for medicines.ie
Updated on 21 September 2020
File name
SPC-Utrogestan Vaginal 200 mg Vaginal Capsules, soft.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.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.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.pdf
Reasons for updating
- New PIL for new product
Updated on 27 August 2020
File name
ie-spc-utrogestan-vaginal-200mg-2020-01-15.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.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)