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Takeda Products Ireland Ltd

First Floor, 3013 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 1 642 0021
Fax: +353 1 642 0020
Medical Information Direct Line: 1800 937970
Medical Information e-mail: DSO-UK@takeda.com
Medical Information Facsimile: +44 (0)1628 526 617
Summary of Product Characteristics last updated on medicines.ie: 12/01/2018
SPC Condyline Cutaneous Solution 0.5 % w/v

When a pharmaceutical company changes an SPC or PIL, 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 12/01/2018 and displayed until Current
Reasons for adding or 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
Date of revision of text on the SPC:   05-Jan-2018
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 06/10/2016 and displayed until 12/01/2018
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   30-Sep-2016
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 14/05/2015 and displayed until 06/10/2016
Reasons for adding or updating:
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-May-2015
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 12/06/2014 and displayed until 14/05/2015
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   31-May-2014
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 11/06/2013 and displayed until 12/06/2014
Reasons for adding or 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
Date of revision of text on the SPC:   22-May-2013
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 18/04/2013 and displayed until 11/06/2013
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Apr-2013
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 13/04/2011 and displayed until 18/04/2013
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
  • Change to improve clarity and readability
Date of revision of text on the SPC:   09-Mar-2011
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 15/07/2010 and displayed until 13/04/2011
Reasons for adding or updating:
  • New SPC for medicines.ie
Date of revision of text on the SPC:  
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

None provided

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Active Ingredients

 
   Podophyllotoxin