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.
In section 1 Name of the medicinal Product the following actives were added: 1. NAME OF THE MEDICINAL PRODUCT Oilatum Plus Bath Additive Light liquid paraffin 52.5% w/w Benzalkonium chloride 6.0% w/w Triclosan 2.0% w/w In section 7 the address of the MAH was updated: 7. MARKETING AUTHORISATION HOLDER Stiefel Laboratories (UK) Ltd Eurasia Headquarters Concorde Road Maidenhead Berks SL6 4BY United Kingdom In section 9 the date of renewal was updated 9. DATE OF FIRST AUTHORISATION / RENEWAL OF AUTHORISATION Date of first authorisation: 25 May 1989 Date of last renewal: 25 May 2009 In section 10 the date of revision of the text 10. DATE OF REVISION OF THE TEXT August 2010
1. NAME OF THE MEDICINAL PRODUCT
Oilatum Plus Bath Additive
Light liquid paraffin 52.5% w/w
Benzalkonium chloride 6.0% w/w
Triclosan 2.0% w/w
In section 7 the address of the MAH was updated:
7. MARKETING AUTHORISATION HOLDER
Stiefel Laboratories (UK) Ltd
Eurasia Headquarters
Concorde Road
Maidenhead
Berks SL6 4BY
United Kingdom In section 9 the date of renewal was updated 9. DATE OF FIRST AUTHORISATION / RENEWAL OF AUTHORISATION Date of first authorisation: 25 May 1989 Date of last renewal: 25 May 2009 In section 10 the date of revision of the text 10. DATE OF REVISION OF THE TEXT August 2010
9. DATE OF FIRST AUTHORISATION / RENEWAL OF AUTHORISATION
Date of first authorisation: 25 May 1989 Date of last renewal: 25 May 2009 In section 10 the date of revision of the text
Date of first authorisation: 25 May 1989
Date of last renewal: 25 May 2009
In section 10 the date of revision of the text
10. DATE OF REVISION OF THE TEXT
August 2010
Change of word from persists to persistent in Section 4.9
Section 1 From Oilatum Plus to Oilatum Plus Bath Additive
Section 2 Benzalkonium chloride is now quoted as neat rather than 50% solution, formulation remains exactly the same. Also a reference to section 6.1 is inserted.
Section 4.6 Wording correction “Pregnancy or …” becomes “pregnancy and lactation”
Section 6.1 ingredients lowercased, composition remains the same.
Section 6.2 Wording change, meaning remains the same.
Section 6.4 Wording change, meaning remains the same.
Section 9 Dates changed following recent renewals/ variations
Section 10 Dates changed following recent renewals/ variations