Azalia 75 microgram film-coated tablets * Pharmacy Only: Prescription
Company:
Consilient Health LtdStatus:
No Recent UpdateLegal 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 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
File name
PIL_16285_987.pdf
Reasons for updating
- New PIL for new product
Updated on 10 October 2017
Reasons for updating
- Change to name of medicinal 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