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Elvina 0.03mg/3mg Film-coated Tablets

Product Information *

  • Company:

    Consilient Health Ltd

  • Status:

    No Recent Update

  • Active Ingredients :

    Drospirenone Ethinylestradiol

    *Additional information is available upon request

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)
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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_1620117330.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 04 May 2021

File name

Information sheet for women - IE Gedeon Richter FINAL_1620117330.pdf

Reasons for updating

  • Add New Doc

Updated on 15 July 2019

File name

01_P0906_345x635-approved 12.06.19_1563099524.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

ie-spc-approved 12.06.19_1563099449.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

PRAC update to inlcude warning of depression and depressed moods as a know side effect in the use of hormonal contraception. Warning in relation to withdrawal bleeding follwoing overdose. 

Updated on 18 December 2018

File name

P0799 345x635 (16-7-18) - approved 13.12.18_1545135038.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 update

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_16286_583.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 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 07 November 2016

Reasons for updating

  • 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 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • 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 (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 4.8 (Undesirable effects), removal of migrane from serious adverse events discussed in section 4.4.$0$0In section 5.2 (Pharmacokinetic properties), updates under biotransformation section for both Drospirenone and Ethinylestradiol.$0$0

Updated on 04 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

Updated on 22 March 2016

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • 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

Section 4.2 - Addition of paediatric population warning.$0$0$0$0Section 4.5 - Addition of new information$0$0$0$0$0Section 4.8 - Addition of new side effects$0$0$0$0

Updated on 21 March 2016

Reasons for updating

  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation

Updated on 21 April 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

Updated on 17 April 2015

Reasons for updating

  • New PIL for new product