Rozex Gel
- Name:
Rozex Gel
- Company:
Galderma International S.A.S. c/o Galderma (U.K) Ltd.
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 23/06/20
(Click to Download)Click on this link to Download PDF directly
Galderma International S.A.S. c/o Galderma (U.K) Ltd.
 Ltd.jpg)
Company Products
| Medicine Name | Active Ingredients |
|---|---|
| Medicine Name Acnecide Gel 5% | Active Ingredients Benzoyl Peroxide, hydrous |
| Medicine Name Azzalure | Active Ingredients Botulinum Toxin Type A |
| Medicine Name Curanail 5% w/v Medicated Nail Lacquer | Active Ingredients Amorolfine Hydrochloride |
| Medicine Name Differin Cream 0.1% w/w | Active Ingredients Adapalene |
| Medicine Name Differin Gel | Active Ingredients Adapalene |
| Medicine Name Efracea capsules | Active Ingredients Doxycycline monohydrate |
| Medicine Name Epiduo 0.1%/2.5% Gel | Active Ingredients Adapalene, Benzoyl Peroxide |
| Medicine Name Etrivex 500 micrograms/g Shampoo | Active Ingredients Clobetasol Propionate |
| Medicine Name Loceryl Nail Lacquer | Active Ingredients Amorolfine Hydrochloride |
| Medicine Name Metvix Cream | Active Ingredients Methyl Aminolevulinate Hydrochloride |
| Medicine Name Mirvaso 3mg/g Gel | Active Ingredients brimonidine tartrate |
| Medicine Name Rozex Cream | Active Ingredients Metronidazole |
| Medicine Name Rozex Gel | Active Ingredients Metronidazole |
| Medicine Name Silkis Ointment | Active Ingredients Calcitriol |
| Medicine Name Soolantra 10 mg/g Cream | Active Ingredients Ivermectin |
| Medicine Name Tetralysal 300 Capsules | Active Ingredients Lymecycline |
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 23 June 2020 PIL
Reasons for updating
- Change of licence holder
Updated on 9 February 2020 SPC
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
- File format updated to PDF
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 20 November 2019 PIL
Reasons for updating
- XPIL Updated
Updated on 18 May 2018 PIL
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 6 - date of revision
Updated on 4 April 2018 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 4 April 2018 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 5.1 - Pharmacodynamic properties
- 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
Section 4.2 - Administrative change, Method of administration underlined
Section 4.3 - parabens deleted
Section 4.7 Registered text changed, From: Rozex cream would not be expected to have any effect on the ability to drive or use machinery. To: Rozex cream has no influence on the ability to drive and use machines.
Section 5.1 - Administrative change, properties, capital “P”to lower case
Section 5.2 - Administrative change, properties, capital “P”to lower case
Section 10: date changed from September 2015 to March 2018
Updated on 27 November 2015 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 27 November 2015 PIL
Reasons for updating
- New PIL for new product
Updated on 27 November 2015 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- 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
Updated on 27 November 2015 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to storage instructions
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to further information section
- Change to date of revision
Updated on 13 February 2014 PIL
Reasons for updating
- Change to appearance of the medicine
Updated on 4 February 2014 SPC
Reasons for updating
- 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
Updated on 8 February 2013 PIL
Reasons for updating
- Change to warnings or special precautions for use
Updated on 22 January 2013 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 25 October 2011 PIL
Reasons for updating
- Change to side-effects
Updated on 24 October 2011 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- 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
Section 4.2 - Details regarding average period of treatment and continued periods of treatment added.
Section 4.4 - Cross-reference to Section 5.3 regarding carcinogenic effects added. Added warnings regarding excipients of known effect.
Section 4.5 - Details regarding disulfiram-like reactions added.
Section 4.7 – Standard wording updated
Section 4.8 - Changed formatting
Section 4.9 - Added extra details regarding overdose
Section 10 - Date updated
Updated on 24 June 2009 PIL
Reasons for updating
- Change due to user-testing of patient information
Updated on 27 July 2007 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to drug interactions
Updated on 20 April 2007 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 19 March 2007 PIL
Reasons for updating
- Change to marketing authorisation holder address
Updated on 1 March 2007 SPC
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
Change to Section 7 - Change in office address of Marketing Authorisation holder
Updated on 1 September 2006 SPC
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
Updated on 18 May 2005 PIL
Reasons for updating
- Change of manufacturer
- Change to date of revision
Updated on 9 August 2004 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 18 June 2003 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)