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Cyklokapron 500mg 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):

    Tranexamic Acid

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

Updated on 14 May 2021

File name

ie-pil-clean-pr2328035.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 02 April 2019

File name

ie-pl-cyklokapron-addmadaus-clean.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 13 February 2019

File name

ie-pl-cyklokapron-mahtransfer-clean.pdf

Reasons for updating

  • New PIL for new product

Updated on 12 February 2019

File name

ie-spc-cyklokapron-mahtransfer-clean.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

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

Updated on 11 August 2016

Reasons for updating

  • New SPC for new product

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

Updated on 11 August 2016

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • 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: Minor text change

In section 4.4: Addition of information regarding convulsions

In section 4.8: Addition of convulsions (frequency not known) to undesirable effects

In section 4.9: Addition of signs and symptoms to overdose

In section 10: Date of revision has changed

Updated on 11 August 2016

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 4.3: Minor text change

In section 4.4: Addition of information regarding convulsions

In section 4.8: Addition of convulsions (frequency not known) to undesirable effects

In section 4.9: Addition of signs and symptoms to overdose

In section 10: Date of revision has changed

Updated on 18 February 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 reporting statement has been added
In section 10: Date of revision has been changed

Updated on 18 February 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 reporting statement has been added
In section 10: Date of revision has been changed

Updated on 14 November 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 4.8 – Undesirable effects - how to report a side effect
  • 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

In section 4.2: Posology has been changed for children and those with renal insufficiency

In section 4.3: there has been additional contraindications added

In section 4.4: Additional information has been added for precautions and warnings

In section 4.8: Additional information regarding side effects has been added

In section 5.2: the pharmacokinetic properties has been expanded and additional text has been added

In section 10: the date of revision has changed

 

Updated on 14 November 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 4.2: Posology has been changed for children and those with renal insufficiency

In section 4.3: there has been additional contraindications added

In section 4.4: Additional information has been added for precautions and warnings

In section 4.8: Additional information regarding side effects has been added

In section 5.2: the pharmacokinetic properties has been expanded and additional text has been added

In section 10: the date of revision has changed

 

Updated on 18 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 18 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 25 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-The trading style of the Marketing Authorisation holder has been removed.

Updated on 25 February 2008

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Free text change information supplied by the pharmaceutical company

Section 7-The trading style of the Marketing Authorisation holder has been removed.

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

Change in MAH from
 
 
Meda AB,

 

Pipers Väg 2,

 

PO Box 906,

 

SE-170 09,

 

Solna,

 

Sweden.

 

Trading style:

 

Meda Pharmaceuticals,

 

Regus House,

 

Pegasus Business Park,

 

Herald Way,

 

Castle Donington,

 

Derbyshire DE74 2TZ

 

England.
 
to
 

Meda Health Sales Ireland Limited

Office 10 , Dunboyne Business Park

Dunboyne

Co Meath

Ireland

 

Trading as

 

Meda Pharma

Office 10 , Dunboyne Business Park

Dunboyne

Co Meath

Ireland
 
and change in PA number from
 
 
PA 1051/5/1
to
PA 1332/3/1
 

Updated on 02 October 2007

Reasons for updating

  • Change to marketing authorisation holder

Free text change information supplied by the pharmaceutical company

Change in MAH from
 
 
Meda AB,

 

Pipers Väg 2,

 

PO Box 906,

 

SE-170 09,

 

Solna,

 

Sweden.

 

Trading style:

 

Meda Pharmaceuticals,

 

Regus House,

 

Pegasus Business Park,

 

Herald Way,

 

Castle Donington,

 

Derbyshire DE74 2TZ

 

England.
 
to
 

Meda Health Sales Ireland Limited

Office 10 , Dunboyne Business Park

Dunboyne

Co Meath

Ireland

 

Trading as

 

Meda Pharma

Office 10 , Dunboyne Business Park

Dunboyne

Co Meath

Ireland
 
and change in PA number from
 
 
PA 1051/5/1
to
PA 1332/3/1
 

Updated on 17 August 2005

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 17 August 2005

Reasons for updating

  • New SPC for medicines.ie