Rozex Gel

  • Name:

    Rozex Gel

  • Company:
    info
  • Active Ingredients:

    Metronidazole

  • 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

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Summary of Product Characteristics last updated on medicines.ie: 9/2/2020

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Galderma International S.A.S. c/o Galderma (U.K) Ltd.

Galderma (U

Company Products

Medicine NameActive 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
1 - 0 of 16 items.Total: Infinity pages

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 SmPC

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 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 4 April 2018 SmPC

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 SmPC

Reasons for updating

  • New SmPC 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 SmPC

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

Update SmPC section 4.8 and PIL. QRD changes also incorporated

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 SmPC

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

In section 3 (Pharmaceutical Form), the appearance of the gel has changed from 'A clear to yellow gel' to 'Colourless to pale yellow homogenous gel, which may turn to sloightly brown colour over time'.

 

Updated on 8 February 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 22 January 2013 SmPC

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

Section 4.4 has been amended to include more information about exposure to UV light.

Updated on 25 October 2011 PIL

Reasons for updating

  • Change to side-effects

Updated on 24 October 2011 SmPC

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 SmPC

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

Update of section 4.2, 4.4 and 4.5

Updated on 19 March 2007 PIL

Reasons for updating

  • Change to marketing authorisation holder address

Updated on 1 March 2007 SmPC

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 SmPC

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

Section 7 - Change of address from Galerma House, Church Lane, Kings Langley, Hertfordshire, WD4 8JP to Meridien House, 69-71 Clarendon Road, Watford, Herts, WD17 1DS

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 SmPC

Reasons for updating

  • New SPC for medicines.ie

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