Elvinette 0.02mg/3mg film-coated tablets

Product Information *

  • Company:

    Consilient Health Ltd
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

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.

EDM Updated on 04 May 2021

File name

CHC prescriber-checklist - IE Gedeon Richter FINAL_1620135061.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 04 May 2021

File name

Information sheet for women - IE Gedeon Richter FINAL_1620135061.pdf

Reasons for updating

  • Add New Doc

Updated on 15 July 2019

File name

01_P0904_345x635-approved 12.06.19_1563100136.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - overdose, missed or forgotten doses

Updated on 14 July 2019

File name

Elvinette 0.02mg-3mg fctbl_SmPC-approved 12.06.19_1563100067.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.9 - Overdose

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update to include warning of depression and depressed moods when using hormonal contraception. Also warning of withdrawal bleeding following overdose. 

Updated on 18 December 2018

File name

P0800 345x635 (16-7-18) - - Approved 13.12.18_1545135147.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 16 November 2017

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

SmPC updated

Updated on 16 November 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 15 November 2017

File name

PIL_16547_987.pdf

Reasons for updating

  • New PIL for new product

Updated on 15 November 2017

Reasons for updating

  • 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 6 - date of revision

Updated on 07 November 2016

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

$0$0In section 4.3 (Contraindications), minor update to wording.$0$0In section 4.3 (Special warning and precautions for use), typo amendment and update to recommendation for patients on a lactose-free diet. $0$0In section 4.5 (Interaction with other medicinal products and other forms of interaction), update to substances decreasing the clearance of COCs and effects of Elvinette on other medicinal products sections.$0$0In section 5.2 (Pharmacokinetic properties), updates under biotransformation section for both Drospirenone and Ethinylestradiol.$0$0In section 5.3 (Preclinical safety data), minor update to wording.$0$0

Updated on 03 November 2016

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 11 May 2016

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Date of renewal application was updated to 22nd December 2015.$0$0$0$0Date of revision of the text was updated to February 2016.$0$0$0$0$0Nature and contents of container we updated to remove "colourless, transparent"$0

Updated on 25 April 2016

Reasons for updating

  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 08 December 2015

Reasons for updating

  • New PIL for medicines.ie
  • PIL Submitted in error

Updated on 06 July 2015

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided