Azzalure

  • Name:

    Azzalure

  • Company:
    info
  • Active Ingredients:

    Botulinum Toxin Type A

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 14/05/19

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Summary of Product Characteristics last updated on medicines.ie: 5/4/2019

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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 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 SmPC

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 SmPC

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 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

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 22 November 2017 SmPC

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 SmPC

Reasons for updating

  • New SmPC 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

  • New PIL for new product

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 4 January 2017 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 4.8 - 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

Addition of new indication (lateral canthal lines) in section 4.1 and associated changes to other sections.

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 SmPC

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

Minor changes to wording and also change of storage time once reconstituted from 4 hours to 24 hours.

Updated on 24 November 2015 PIL

Reasons for updating

  • Change to storage instructions
  • Change to date of revision

Updated on 13 April 2015 SmPC

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

the new approved SPC and PIL for Azzalure  following approval of the renewal

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 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided