Azzalure *
Pharmacy Only: Prescription

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 04 November 2021

File name

210730A-uk-ie-pl-clean-47_AZZ_UKIE_1635987525.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Free text change information supplied by the pharmaceutical company

Grouped Type II variation safety update to SmPC Section 4.4: rewording of the interchangeability paragraph and addition of a warning about ‘dry eye’; Section 4.8: addition of the ADR ‘hypersensitivity’ and ‘muscle atrophy’ in post marketing experience; updates to HPRA contact details for adverse event reporting; Section 6.6: addition of colour information for the reconstituted solution; consequential updates made to the PIL. Variation approval e-mail issued 30Jul2021 by HPRA.

Updated on 04 November 2021

File name

210730A-ie-spc-clean-46_AZZ_IE_1635987196.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

Grouped Type II variation safety update to SmPC Section 4.4: rewording of the interchangeability paragraph and addition of a warning about ‘dry eye’; Section 4.8: addition of the ADR ‘hypersensitivity’ and ‘muscle atrophy’ in post marketing experience; updates to HPRA contact details for adverse event reporting; Section 6.6: addition of colour information for the reconstituted solution; consequential updates made to the PIL. Variation approval e-mail issued 30Jul2021 by HPRA.

Updated on 21 March 2021

File name

210309A-uk-ie-pl-clean-44_AZZ_1616316611.pdf

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

File name

210309A-ie-spc-clean-43_AZZ_1616316229.pdf

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

File name

190430A uk-ie-pl-cl-40_AZZ_UKIE_1557840631.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 05 April 2019

File name

190325A uk-ie-pl-cl-39_AZZ_UKIE_1554476823.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 05 April 2019

File name

Azzalure IRE SPC V11 med.ie_1554476659.pdf

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 04 September 2018

File name

Azzalure PIL UK & IRE V9 (1056451)_1536058779.pdf

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 04 September 2018

File name

Azzalure IRE SPC V10_1536058491.pdf

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

File name

Azzalure PIL -IRE (MAH) cl_1535114107.pdf

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

File name

Azzalure IRE SPC V9_1535113585.pdf

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

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

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

File name

PIL_15177_180.pdf

Reasons for updating

  • New PIL for new product

Updated on 21 November 2017

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 04 January 2017

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

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

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

Reasons for updating

  • Change to storage instructions
  • Change to date of revision

Updated on 13 April 2015

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 02 April 2015

Reasons for updating

  • Change to date of revision
  • Change of special precautions for disposal

Updated on 25 October 2011

Reasons for updating

  • New PIL for new product

Updated on 17 January 2011

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