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Colifoam 10% w/w Rectal Foam *
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):

    Hydrocortisone Acetate

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

Updated on 14 June 2019

File name

ie-spc-colifoam-mahtransfer-clean_1560509412.pdf

Reasons for updating

  • Change to improve clarity and readability

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

Updated on 29 June 2018

File name

ie-spc-colifoam-mahtransfer-clean.docx

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

Marketing Authorisation Holder Transfer from Meda Health Sales Ireland Limited to Mylan IRE Healthcare Limited. 

Updated on 29 June 2018

File name

ie-pl-colifoam-mahtransfer-clean.pdf

Reasons for updating

  • New PIL for new product

Updated on 12 July 2017

Reasons for updating

  • New SPC for new product

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

Updated on 12 July 2017

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 4.6 - 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 4.3: Information has been added

In section 4.4: Information has been added regarding special warning and precautions for use

In section 4.5: Information has been added regarding interactions with other medicinal products and other forms of interaction

In section 4.6: Information removed regarding pregnancy and information added regarding breast-feeding

In section 4.7: information added that Colifoam has no influence on ability to drive and operate machinery

In section 4.8: Undesirable effects recategorized

In section 4.9: Information regarding over dosage has been added

In section 5.1: Pharmacotherapeutic group and ATC code added. Information added regarding mechanism of action.

In section 5.2: Information regarding bioavailability has been added

In section 5.3: Information regarding animal studies has been added.

In section 10: Date of revision changed.

Updated on 12 July 2017

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 4.6 - 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

Free text change information supplied by the pharmaceutical company

In section 4.3: Information has been added

In section 4.4: Information has been added regarding special warning and precautions for use

In section 4.5: Information has been added regarding interactions with other medicinal products and other forms of interaction

In section 4.6: Information removed regarding pregnancy and information added regarding breast-feeding

In section 4.7: information added that Colifoam has no influence on ability to drive and operate machinery

In section 4.8: Undesirable effects recategorized

In section 4.9: Information regarding over dosage has been added

In section 5.1: Pharmacotherapeutic group and ATC code added. Information added regarding mechanism of action.

In section 5.2: Information regarding bioavailability has been added

In section 5.3: Information regarding animal studies has been added.

In section 10: Date of revision changed.

Updated on 22 May 2017

Reasons for updating

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

In section 4.4: Information regarding visual disturbance has been added.

In section 4.8: Blurred vision has been added to undesirable effects with frequency of not known

In section 10: The date of revision has been changed.

Updated on 22 May 2017

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 4.4: Information regarding visual disturbance has been added.

In section 4.8: Blurred vision has been added to undesirable effects with frequency of not known

In section 10: The date of revision has been changed.

Updated on 06 February 2017

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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

In section 4.5: Information regarding interaction with Co-treatment with CYP3A inhibitors, including cobicistat-containing products has been added.

In section 10: Date of revision changed.

Updated on 06 February 2017

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 4.5: Information regarding interaction with Co-treatment with CYP3A inhibitors, including cobicistat-containing products has been added.

In section 10: Date of revision changed.

Updated on 20 March 2015

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

In section 4.8: Adverse reaction statement has been added
In section 10: Date of revision has changed

Updated on 20 March 2015

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 4.8: Adverse reaction statement has been added
In section 10: Date of revision has changed

Updated on 02 November 2011

Reasons for updating

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

In section 4.4; there are additional excipient warnings included at the end of this section.
In section 10; the date of revision has changed

Updated on 02 November 2011

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 4.4; there are additional excipient warnings included at the end of this section.
In section 10; the date of revision has changed

Updated on 18 March 2011

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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

In section 4.8: a type error was corrected
In section 6.6: typo errors were corrected

Updated on 18 March 2011

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 6.6 - Special precautions for disposal and other handling

Free text change information supplied by the pharmaceutical company

In section 4.8: a type error was corrected
In section 6.6: typo errors were corrected

Updated on 14 March 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

In section 7: the address of the MAH has changed
In section 10: the date of revision has changed to Feb 2011

Updated on 14 March 2011

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 7: the address of the MAH has changed
In section 10: the date of revision has changed to Feb 2011

Updated on 29 February 2008

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

Section 7-removal of trading style of the MAH.

Updated on 29 February 2008

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Free text change information supplied by the pharmaceutical company

Section 7-removal of trading style of the MAH.

Updated on 02 October 2007

Reasons for updating

  • 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 has changed from 

 

Meda AB

 

PO Box 906

 

SE-170-09 Solna

 

Sweden

 

Trading as:

 

Meda Pharmaceuticals

 

Regus House

 

Pegasus Business Park

 

Herald Way

 

Castle Donington

 

Derbyshire

 

DE74 2TZ
 
to

Meda Health Sales Ireland Limited

Office 10, Dunboyne Business Park

Dunboyne

Co Meath

Ireland

 

Trading as

 

Meda Pharma
 
PA number has changed from 
PA 1051/3/1
to
PA 1332/2/1
 

Updated on 02 October 2007

Reasons for updating

  • Change to marketing authorisation holder

Free text change information supplied by the pharmaceutical company

MAH has changed from 

 

Meda AB

 

PO Box 906

 

SE-170-09 Solna

 

Sweden

 

Trading as:

 

Meda Pharmaceuticals

 

Regus House

 

Pegasus Business Park

 

Herald Way

 

Castle Donington

 

Derbyshire

 

DE74 2TZ
 
to

Meda Health Sales Ireland Limited

Office 10, Dunboyne Business Park

Dunboyne

Co Meath

Ireland

 

Trading as

 

Meda Pharma
 
PA number has changed from 
PA 1051/3/1
to
PA 1332/2/1
 

Updated on 10 August 2004

Reasons for updating

  • Improved electronic presentation

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

Updated on 10 August 2004

Reasons for updating

  • Improved electronic presentation

Updated on 27 January 2004

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 27 January 2004

Reasons for updating

  • New SPC for medicines.ie