Azzalure
- Name:
Azzalure
- Company:
Galderma International S.A.S. c/o Galderma (U.K) Ltd.
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 21/03/21
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Galderma International S.A.S. c/o Galderma (U.K) Ltd.
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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 21 March 2021 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Type II variation approved 9Mar2021 by HPRA to revise SmPC section 4.8 (and PIL) to incorporate post-marketing ADR hypoesthesia, frequency unknown, as per CCDS.
Updated on 21 March 2021 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Type II variation approved 9Mar2021 by HPRA to revise SmPC section 4.8 (and PIL) to incorporate post-marketing ADR hypoesthesia, frequency unknown, as per CCDS.
Updated on 14 May 2019 PIL
Reasons for updating
- Change to section 6 - manufacturer
Updated on 5 April 2019 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 5 April 2019 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 2: Removal of reference to LD50
Section 4.8: Update to safety ADR section for the Glabellar Lines indication (change the frequency category for eye movement disorder from “uncommon” to “rare”)
Section 10: Updated date of revision
Updated on 4 September 2018 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to information for healthcare professionals
Updated on 4 September 2018 SPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- 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 not be renewed (A)
Updated on 24 August 2018 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 24 August 2018 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
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 22 November 2017 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.8 - Addition of ADR (dry eye in LCL indication)
Section 5.1 - Editorial Change
Section 10 - Updated revision of text date
Updated on 22 November 2017 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 21 November 2017 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 21 November 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 4 January 2017 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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 23 December 2016 PIL
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
Updated on 27 November 2015 SPC
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 24 November 2015 PIL
Reasons for updating
- Change to storage instructions
- Change to date of revision
Updated on 13 April 2015 SPC
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 2 April 2015 PIL
Reasons for updating
- Change to date of revision
- Change of special precautions for disposal
Updated on 25 October 2011 PIL
Reasons for updating
- New PIL for new product
Updated on 17 January 2011 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may not be renewed (A)