Condyline Cutaneous Solution 5 mg/ml

Product Information *

  • Company:

    Takeda Products Ireland Ltd
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

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

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 03 June 2021

File name

m1-3-1-IRE-leaflet-condyline-clean-edited-03062021_1622732348.pdf

Reasons for updating

  • Correction of spelling/typing errors

Updated on 03 June 2021

File name

m1-3-1-ire-leaflet-condyline-clean-Nov2020_1622724160.pdf

Reasons for updating

  • New PIL for new product

Updated on 03 June 2021

File name

m1-3-1-IRE-spc-condyline-clean-revised-May2021_1622724005.pdf

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • 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
  • Updated inline with QRD template and/or excipient guideline

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

Updated on 07 May 2020

File name

ie-spc-condyline-21.04.2020 (002)_1588859899.pdf

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 (Marketing Authorisation Holder), the address has been updated to:

6th Floor

South Bank House

Barrow Street

Dublin 4

Ireland

 

This is the new legally registered office.

 

The date of revision is: 21 April 2020

Updated on 27 September 2019

File name

ie-pl-condyline-24.09.2019_1569587748.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 6 - what the product contains

Free text change information supplied by the pharmaceutical company

There has been a change in  the way the strength is expressed in the product name from Condyline 0.5%w/v cutaneous solution to Condyline 5 mg/ml cutaneous solution. In the PIL this has been updated in the heading and in section 6.

Updated on 27 September 2019

File name

ie-spc-condyline-24.09.2019_1569587623.pdf

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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

There has been a change in  the way the strength is expressed in the product name from Condyline 0.5%w/v cutaneous solution to Condyline 5 mg/ml cutaneous solution. This has been changed in sections 1, 2 and 3.

Updated on 12 January 2018

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

The Marketing Authorisation Holder has been updated to Takeda Products Ireland Ltd.
The Marketing Authorisation Number has been updated to PA 2229/006/001

Updated on 12 January 2018

Reasons for updating

  • New SPC for new product

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

Updated on 12 January 2018

File name

PIL_14611_528.pdf

Reasons for updating

  • New PIL for new product

Updated on 12 January 2018

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 August 2017

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - what you need to know - contraindications
  • 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 - how to take/use
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision
  • Improved presentation of PIL

Updated on 27 February 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 06 October 2016

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

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 marketing authorisation holder has been updated to:

Takeda UK Limited,

Building 3,

Glory Park,

Glory Park Avenue,

Wooburn Green,

Bucks,

HP10 0DF

UK


In section 8 the MA number has been updated to:
PA 1547/010/001
Date of revision of text has been updated to 30 September 2016


 

Updated on 30 September 2016

Reasons for updating

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

Updated on 14 May 2015

Reasons for updating

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

Updated on 14 May 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

4.8. Undesirable effects

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

 

10. DATE OF REVISION OF TEXT

01st May 2015

 

Updated on 12 June 2014

Reasons for updating

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

Updated on 12 June 2014

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

7. MARKETING AUTHORISATION HOLDER

The approval of a variation to amend the MA holder address for Condyline:

 

From

 

Takeda Pharma A/S

Langebjerg 1

P.O. Box 88

DK-4000 Roskilde

Denmark

 

To

 

 

Takeda Pharma A/S

Dybendal Allé 10

2630 Taastrup

Denmark

 

10. DATE OF REVISION OF TEXT

31st May 2014

Updated on 11 June 2013

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 4.6 - Pregnancy and lactation
  • 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 4.1 (Therapeutic indications) addition of the word acuminata (For the topical treatment of condylomata acuminata (warts) affecting the penis or the female external genitalia).
In section 4.2 Posology and method of administration). Adults and elderly: Addition of Only a small area or number of warts should be treated at any one time.
                                                                                Children: Wording changed to: Not recommended in children under 12 years of age.
In section 4.3 (Contraindications): Wording amended in following subsections: known or suspected hypersensitivity to podophyllotoxin or to any of the other ingredients (see section 6.1)            and pregnant or breast-feeding women (see section 4.6);       
In section 4.6 (Fertility, pregnancy and lactation): Addition of:      Studies in animals have shown reproductive toxicity (see section  5.3).   
In section 4.9 (Overdose) Addition of a Symptoms section 
In section 5.1 (Pharmacodynamic Properites) Wording amended.
In section 5.2 (Pharmacokinetic Properties) Reworded and information added as Absorption, Distribution, Metabolism and Elimination subsections. 
In section 5.3 (Preclinical safety data)     Wording amended.     
In section 10 (Date of revision of text) Date amended to 22nd May 2013                                                    

                                                                                      

Updated on 18 April 2013

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

7.       MARKETING AUTHORISATION HOLDER

 

Takeda Pharma A/S

Langebjerg 1

P.O. Box 88

DK-4000 Roskilde

Denmark

 

10.     DATE OF REVISION OF TEXT

 

1st April 2013

 

Updated on 13 April 2011

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to improve clarity and readability

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

Free text change information supplied by the pharmaceutical company

Addition of in-use shelf-life.

Alignment of SmPC with the QRD template.

Updated on 15 July 2010

Reasons for updating

  • New SPC for medicines.ie

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 18 March 2010

Reasons for updating

  • New PIL for medicines.ie
  • PIL Submitted in error