Condyline Cutaneous Solution 5 mg/ml *
Company:
Takeda Products Ireland LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
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 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
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 4.2 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
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
Updated on 18 March 2010
Reasons for updating
- New PIL for medicines.ie
- PIL Submitted in error