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

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)