Utrogestan® Vaginal 200 mg Vaginal Capsules, soft *
Pharmacy Only: Prescription

  • Company:

    Besins Healthcare (UK) Ltd
  • Status:

    No Recent Update
  • Legal 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)