Duphaston 10mg Film-Coated Tablets * Pharmacy Only: Prescription
Company:
Mylan IRE Healthcare LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 01 October 2021
File name
IE-SmPC-Duphaston 10mg-WS094-Aug2021-clean_1633076831.pdf
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.3 - Preclinical safety data
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 October 2021
File name
IE-PIL-Duphaston 10mg-WS094-Aug2021-clean_1633076715.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
Updated on 04 July 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 04 July 2017
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
7. MARKETING AUTHORISATION HOLDER
Mylan IRE Healthcare Limited
Unit 35/36
Grange Parade
Baldoyle Industrial Estate
Dublin 13
Ireland
BGP Products Ireland Limited
4051 Kingswood Drive,
Citywest Business Campus,
Dublin 24
8. MARKETING AUTHORISATION NUMBER
PA 2010/010/001 2007/5/1
10. DATE OF REVISION OF THE TEXT
June 2017
Updated on 30 June 2017
File name
PIL_8806_223.pdf
Reasons for updating
- New PIL for new product
Updated on 30 June 2017
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 15 December 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 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.3: Addition of "(e.g. meningioma)"
Section 4.4: Update of Ovarian cancer section, addition of lactose excipient warning
Section 4.5: Update of text regarding metabolic pathway of dydrogesterone. Deletion of valerian root.
Section 4.8: Addition of text for Reporting of suspected adverse reactions.
Section 4.4: Update of Ovarian cancer section, addition of lactose excipient warning
Section 4.5: Update of text regarding metabolic pathway of dydrogesterone. Deletion of valerian root.
Section 4.8: Addition of text for Reporting of suspected adverse reactions.
Updated on 15 December 2016
Reasons for updating
- 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 - dose and frequency
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
Updated on 27 September 2016
Reasons for updating
- Change of distributor details
Updated on 02 April 2015
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In Section 7:
Change of MA Holder from Abbott Healthcare Products Limited to BGP Products Ltd
In Section 8:
Change of PA number from PA 108/10/1 to PA 2007/5/1
Change of MA Holder from Abbott Healthcare Products Limited to BGP Products Ltd
In Section 8:
Change of PA number from PA 108/10/1 to PA 2007/5/1
Updated on 30 March 2015
Reasons for updating
- Change to marketing authorisation holder
Updated on 11 September 2014
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 7 has been changed.....
from: Abbott Healthcare Products Limited.,
Mansbridge Road,
West End, Southampton,
SO18 3JD, United Kingdom
to: Abbott Healthcare Products Limited.,
Abbott House, Vanwall Business Park,
Vanwall Road, Maidenhead,
SL6 4XE, United Kingdom
from: Abbott Healthcare Products Limited.,
Mansbridge Road,
West End, Southampton,
SO18 3JD, United Kingdom
to: Abbott Healthcare Products Limited.,
Abbott House, Vanwall Business Park,
Vanwall Road, Maidenhead,
SL6 4XE, United Kingdom
Updated on 08 September 2014
Reasons for updating
- Change to MA holder contact details
Updated on 28 February 2013
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4 - Clinical particulars
- 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 4.5 - 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 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.1 - List of excipients
- Change to section 6.4 - Special precautions for storage
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Extensive safety changes to SPC as a result of Type II CI4 variation approval. Reference to estrogen was deleted throughout SPC.
See each section of SPC for full details of changes, sections amended: 2 , 3, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3.
e.g. addition of pre-menstrual syndrome to section 4.1: indications
changes to undesirable effects section 4.8
In addition section 6.1 and 6.4 were updated as a result of Type IB
- section 6.1: addition of Hypromellose to excipients (film-coating), deletion of purified water
- section 6.4: storage conditions amended to: This medicinal product does not require any special storage condition.
See each section of SPC for full details of changes, sections amended: 2 , 3, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3.
e.g. addition of pre-menstrual syndrome to section 4.1: indications
changes to undesirable effects section 4.8
In addition section 6.1 and 6.4 were updated as a result of Type IB
- section 6.1: addition of Hypromellose to excipients (film-coating), deletion of purified water
- section 6.4: storage conditions amended to: This medicinal product does not require any special storage condition.
Updated on 26 February 2013
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to storage instructions
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to further information section
- Change to date of revision
- Change to dosage and administration
- Changes to therapeutic indications
Updated on 05 September 2011
Reasons for updating
- Change to section 3 - Pharmaceutical form
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Removal of the Solvay logo 'S' embossed on the film coated tablets
Updated on 01 September 2011
Reasons for updating
- Change to appearance of the medicine
Updated on 05 April 2011
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 7
The following has been updated as highlighted;
Abbott Healthcare Products Limited
Mansbridge Road
West End
Southampton
SO18 3JD
United Kingdom
Updated on 04 April 2011
Reasons for updating
- Change to marketing authorisation holder
- Change to MA holder contact details
- Change to name of manufacturer
Updated on 08 November 2010
Reasons for updating
- Change due to user-testing of patient information
Updated on 15 January 2010
Reasons for updating
- Change of manufacturer
- Change to date of revision
Updated on 03 September 2009
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 4.5 - 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 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.4 - Special precautions for storage
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The changes are as follows:
- Update section 4.6 with a contraindication for known or suspected progesterone dependant neoplasma and as a consequence update section 4.8 of the SPc.
- Update section 4.4 of the SPC with additional information about caution for use in patient with liver function problems.
- Update section 4.6 and as a consequence section 5.3 of the SPC with information relating to the use in pregnant and lactating patients.
- Update the medical sections (4.2, 4.5, 4.7, 4.9 and 5.1) to be in line with SPC guidelines.
- Update the pharmaceuticals sections (2, 6.4, 6.6) in line with SPC guidelines.
- Update section 4.6 with a contraindication for known or suspected progesterone dependant neoplasma and as a consequence update section 4.8 of the SPc.
- Update section 4.4 of the SPC with additional information about caution for use in patient with liver function problems.
- Update section 4.6 and as a consequence section 5.3 of the SPC with information relating to the use in pregnant and lactating patients.
- Update the medical sections (4.2, 4.5, 4.7, 4.9 and 5.1) to be in line with SPC guidelines.
- Update the pharmaceuticals sections (2, 6.4, 6.6) in line with SPC guidelines.
Updated on 05 April 2007
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 24 February 2006
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 January 2006
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 08 August 2005
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
- Change to section 6.1 - List of excipients
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 July 2005
Reasons for updating
- Correction of spelling/typing errors
Updated on 23 May 2005
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 25 November 2004
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 4.5 - 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 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- 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 not be renewed (A)
Updated on 18 October 2004
Reasons for updating
- New PIL for new product
Updated on 18 October 2004
Reasons for updating
- Improved electronic presentation
Updated on 26 June 2003
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)