Vaniqa 11.5% cream

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 25/09/17

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Summary of Product Characteristics last updated on medicines.ie: 26/9/2017
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Almirall Limited

Almirall Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Almogran 12.5 mg Film-coated tablet Active Ingredients Almotriptan D, L-hydrogen malate
Medicine Name Meptid 100 mg/ml Solution for Injection Active Ingredients Meptazinol hydrochloride
Medicine Name Meptid 200 mg Film-Coated Tablets Active Ingredients Meptazinol hydrochloride
Medicine Name Skilarence 30 mg gastro-resistant tablets Active Ingredients Dimethyl fumarate
Medicine Name Skilarence 30 mg, 120 mg gastro-resisistant tablets Active Ingredients Dimethyl fumarate
Medicine Name Solaraze 3% Gel Active Ingredients Diclofenac Sodium
Medicine Name Vaniqa 11.5% cream Active Ingredients Eflornithine hydrochloride monohydrate
1 - 0 of 7 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 26 September 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 26 September 2017 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life
  • 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 to sections 2, 4.2, 4.3, 4.6, 4.7, 5.1, 6.3, 6.6 and 10 due to QRD update.

Updated on 25 September 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 25 September 2017 PIL

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 3 - dose and frequency
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 24 September 2014 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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

Free text change information supplied by the pharmaceutical company

The amendment includes the QRD template wording to section 4.8 of the SmPC as follows:

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine

United Kingdom
Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard

Ireland
HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.hpra.ie, e-mail: medsafety@hpra.ie

Updated on 17 September 2014 PIL

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 1 May 2013 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration

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

Free text change information supplied by the pharmaceutical company

Changes to the SmPC include:

Section 4.1: Restriction of the indication to adult women

Section 4.2: Removal of dosing instructions for adolescents aged 12-18 years.

Updated on 29 April 2013 PIL

Reasons for updating

  • Change to dosage and administration
  • Changes to therapeutic indications

Updated on 11 July 2011 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - 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 6.6 - Special precautions for disposal and other handling
  • Change to section 2 - Qualitative and quantitative composition

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

Free text change information supplied by the pharmaceutical company

Section 2 - Quantities of excipients added
Section 4.1 - Reference to female adolescents and adult women added
Section 4.2 - Reworded
Section 4.4 - Reference to the potential for methyl parahydroxybenzoate and propyl parahydroxybenzoate to cause allergic reactions added
Section 4.6 - Information on fertility added
Section 4.7 - Vaniqa has no or negligable effects on the ability to drive and use machines
Section 4.8 - Frequency information updated
Section 6.6 - Any unused product or waste material should be disposed of in accordance with local requirements

Updated on 4 May 2011 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to dosage and administration
  • Addition of manufacturer
  • Changes to therapeutic indications

Updated on 11 March 2011 PIL

Reasons for updating

  • Change to name of manufacturer

Updated on 14 October 2010 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to MA holder contact details

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

Free text change information supplied by the pharmaceutical company

MAH contact details have been changed from 'Laboratorios Almirall, S.A.' to 'Almirall, S.A.'

Updated on 4 December 2009 SmPC

Reasons for updating

  • Change to section 6.1 - List of excipients
  • 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 6.1 (list of excipients), "sodium hydroxide (E524) (to adjust pH) has been added.

Updated on 30 November 2009 PIL

Reasons for updating

  • Change to further information section

Updated on 1 September 2009 SmPC

Reasons for updating

  • Addition of separate SPCs covering individual presentations

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 26 August 2009 PIL

Reasons for updating

  • New PIL for medicines.ie