Azzalure * Pharmacy Only: Prescription
Company:
Galderma International S.A.S. c/o Galderma (U.K) Ltd.Status:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 13 June 2022
File name
62a79944103c8.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to further information section
- Change to date of revision
Free text change information supplied by the pharmaceutical company
HPRA approval (issued 30th May 2022) of the Article 61(3) application/notification for Azzalure to remove all UK MA-related administrative details from the shared UK and IE leaflet (and carton label) to create a stand-alone IE leaflet (and carton label). Also included (in the further information section) an update of the address for the appointed distributor (Galderma) from Watford to Euston.
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
- New SPC for new product
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 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
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
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
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)