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Colofac 135mg Tablets

*
Pharmacy Only: Prescription

  • Company:

    Mylan IRE Healthcare Ltd

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Mebeverine Hydochloride

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

Updated on 12 December 2022

File name

SPC_Colofac_crn2187476_Transfer_30Jun17_approved_clean.pdf

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 05 July 2017

Reasons for updating

  • New SPC for new product

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

Updated on 05 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 be renewed (B)

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 2010/7/1 2007/2/1

10. DATE OF REVISION OF THE TEXT

 

June 2017

Updated on 30 June 2017

File name

PIL_8805_84.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 10 October 2016

Reasons for updating

  • Change to date of revision
  • Change of distributor details

Updated on 13 August 2015

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 20 April 2015

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • 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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

Sections 5.1 and 5.3 have been updated to reflect the current scientific knowledge as well as editorial changes to sections 2, 4.3, 4.5, 4.6, 4.8 (addition of SAE reporting), 4.9.

Updated on 16 April 2015

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 08 April 2015

Reasons for updating

  • Change of licence holder
  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 07 April 2015

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
  • Change to marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

MAH Transfer to change the MAH and PA no.

Updated on 02 October 2014

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to MA holder contact details

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

Free text change information supplied by the pharmaceutical company

Change in the MAH address from Southampton to Maidenhead UK

Updated on 29 September 2014

Reasons for updating

  • Change to MA holder contact details

Updated on 22 April 2013

Reasons for updating

  • 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 6.6 - Special precautions for disposal and other handling

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

Free text change information supplied by the pharmaceutical company

Extensive changes to most SPC sections

Updated on 18 April 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 drug interactions
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to dosage and administration
  • Change due to user-testing of patient information

Updated on 17 February 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Due to an acquisition of Solvay by Abbott, Solvay Healthcare Limited will now be known as Abbott Healthcare Products Limited and are labelling are being brought in line to reflect this.

Updated on 16 February 2011

Reasons for updating

  • Change to marketing authorisation holder
  • Change to name of manufacturer

Updated on 23 January 2009

Reasons for updating

  • 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 4.8 of the SPC has been updated to include "rash"

Updated on 05 December 2008

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 9 - Date of renewal of authorisation

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

Free text change information supplied by the pharmaceutical company

Section 2: To include information on sugars and the standard excipient wording
Section 9: To include the new renewal date

Updated on 04 December 2008

Reasons for updating

  • Change to marketing authorisation holder

Updated on 28 June 2006

Reasons for updating

  • Change of manufacturer

Updated on 28 March 2006

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 4.4 - Special warnings and precautions for use

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

Updated on 28 March 2006

Reasons for updating

  • Change of active ingredient
  • Change to warnings or special precautions for use

Updated on 20 July 2005

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 18 October 2004

Reasons for updating

  • New PIL for new product