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Azalia 75 microgram film-coated tablets *

  • Company:

    Consilient Health Ltd

  • Status:

    Updated

  • Legal Category:

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

  • Active Ingredient(s):

    Desogestrel

    *Additional information is available within the SPC or upon request to the company

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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.

Updated on 20 September 2021

File name

ie-spc-approved 10.09.2021_1632129596.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Updated on 20 September 2021

File name

ie-pl-approved 10.09.2021_1632129563.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 23 April 2021

File name

ie-spc-approved 12.10.20_1619167688.pdf

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation

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

Updated on 23 April 2021

File name

ie-pl-approved 12.10.20_1619167623.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility

Updated on 13 May 2019

File name

Azalia A4 PLAIN PIL 7.3 approved 15.02.19_1557747188.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 13 May 2019

File name

Azalia 75 mcg fctbl_SmPC_en_PA1330-010-001-approved 15.02.19_1557747642.pdf

Reasons for updating

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

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

Free text change information supplied by the pharmaceutical company

Updated to included warning with regards to depressed mood and depression. 

Updated on 19 November 2018

File name

Azalia A4 PIL - word version_1542632099.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 24 April 2018

File name

P0739 180x500 (9-4-18).pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects

Updated on 09 April 2018

Reasons for updating

  • New SPC for new product

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

Updated on 09 April 2018

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • 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

$0Section 4.2 - under Paediatric population the desogestrel is replaced with Azalia.  $0$0Section 4.4 -  further information included regarding the efficacy of Azalia and information on Laboratory tests from section 4.5 to 4.4. $0$0Section 4.5 -  Updating in line with reference product. $0$0Section 4.6 - Removal of brand name and inclusion of active name with reference to available data with use in Children.  $0$0Section 4.7 - Spelling correction$0$0Section 4.8 - inclusion of strength and form of active used (75 microgram tablets) and inclusion of statement regarding breakthrough bleeding.  $0$0Section 5.1 - Addition of hormonal contraceptives for systemic use as a Pharmacotherapeutic group and inclusion of the strength and form of active used (75 microgram tablets) $0Section 5.2: Inclusion of "SHGB"$0$0Section 10:  date updated to reflect approval $0$0$0$0

Updated on 06 April 2018

File name

PIL_16285_307.pdf

Reasons for updating

  • New PIL for new product

Updated on 06 April 2018

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - duration of treatment
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 10 October 2017

Reasons for updating

  • Change to name of medicinal product

Updated on 10 October 2017

File name

PIL_16285_987.pdf

Reasons for updating

  • New PIL for new product

Updated on 12 January 2017

Reasons for updating

  • Correction of spelling/typing errors

Updated on 25 May 2016

Reasons for updating

  • Correction of spelling/typing errors

Updated on 22 January 2016

Reasons for updating

  • New SPC for new product

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

Updated on 22 January 2016

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 4.2, information about special populations has been updated$0$0In section 4.6, information about fertility has been added$0$0In section 5.1, the headings mechanism of action and clinical efficacy and safety have been added$0$0In section 5.2, information about special populations has been added$0$0In section 10, the revision date has changed$0$0

Updated on 02 December 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to instructions about missed dose
  • Change to drug interactions

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