Vaniqa 11.5% cream
- Name:
Vaniqa 11.5% cream
- Company:
Almirall Limited
- 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: 20/01/20
(Click to Download) Summary of Product Characteristics last updated on medicines.ie: 26/9/2017
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1. NAME OF THE MEDICINAL PRODUCT
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4. CLINICAL PARTICULARS
5. PHARMACOLOGICAL PROPERTIES
5. PHARMACOLOGICAL PROPERTIES
6. PHARMACEUTICAL PARTICULARS
6. PHARMACEUTICAL PARTICULARS
7. MARKETING AUTHORISATION HOLDER
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
10. DATE OF REVISION OF THE TEXT
Almirall Limited
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| 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 |
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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 20 January 2020 PIL
Reasons for updating
- Change to date of revision
Free text change information supplied by the pharmaceutical company
Change of local representative in Ireland and update of date of revision to 03/2019
Updated on 26 September 2017 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 26 September 2017 SPC
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 SPC
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
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 SPC
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.
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 SPC
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
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 SPC
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 SPC
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 SPC
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