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Duphaston 10mg Film-Coated Tablets

  • Name:

    Duphaston 10mg Film-Coated Tablets

  • Company:
    info
  • Active Ingredients:

    Dydrogesterone

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 30/06/17

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Summary of Product Characteristics last updated on medicines.ie: 4/7/2017
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Mylan IRE Healthcare Limited

Mylan IRE Healthcare Limited

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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 4 July 2017 SPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 4 July 2017 SPC

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 PIL

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 30 June 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 15 December 2016 PIL

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 15 December 2016 SPC

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.

Updated on 27 September 2016 PIL

Reasons for updating

  • Change of distributor details

Updated on 2 April 2015 SPC

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

Updated on 30 March 2015 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 11 September 2014 SPC

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

Updated on 8 September 2014 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 28 February 2013 SPC

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.

 

Updated on 26 February 2013 PIL

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 5 September 2011 SPC

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 1 September 2011 PIL

Reasons for updating

  • Change to appearance of the medicine

Updated on 5 April 2011 SPC

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 4 April 2011 PIL

Reasons for updating

  • Change to marketing authorisation holder
  • Change to MA holder contact details
  • Change to name of manufacturer

Updated on 8 November 2010 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 15 January 2010 PIL

Reasons for updating

  • Change of manufacturer
  • Change to date of revision

Updated on 3 September 2009 SPC

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.

Updated on 5 April 2007 SPC

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 SPC

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 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 8 August 2005 SPC

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 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 23 May 2005 PIL

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 SPC

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 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 18 October 2004 PIL

Reasons for updating

  • New PIL for new product

Updated on 26 June 2003 SPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)