Lucentis 10mg/ml solution for injection in pre-filled syringe
*Company:
Novartis Ireland LimitedStatus:
No Recent UpdateLegal 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
File name
Lucentis Neovascular-Wet AMD Revised July 24.mp3
Free text change information supplied by the pharmaceutical company
Addition of audio file
File name
Lucentis Macular Edema RVO revised July 24.mp3
Free text change information supplied by the pharmaceutical company
Addition of audio file
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Lucentis CNV Revised July 24.mp3
Free text change information supplied by the pharmaceutical company
Addition of audio file
Updated on 11 July 2024
File name
Lucentis PFS REG PIL PF23-074 February 2023_clean_removal of UK(NI)_clean_IPHA.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to MA holder contact details
Free text change information supplied by the pharmaceutical company
Removal of details for UK(NI)
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Patient_Booklet_Audio.mp3
Reasons for updating
- Add New Audio
Free text change information supplied by the pharmaceutical company
First upload to medicines.ie
File name
FINAL Lucentis_-_Lucentis_Patient_DME_Booklet.pdf
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
New document
Updated on 31 May 2023
File name
Lucentis PFS REG PIL PF23-074 February 2023_clean IPHA.pdf
Reasons for updating
- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
Removal of alternative BRS site
Updated on 20 April 2023
File name
Lucentis PFS REG SPC PF23-074 February 2023_clean IPHA.pdf
Reasons for updating
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 30 March 2023
File name
Lucentis PFS REG PIL PF23-074 February 2023_clean IPHA.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to information for healthcare professionals
Free text change information supplied by the pharmaceutical company
Change appearance to 'a sterile, clear, colourless to pale brownish-yellow aqueous solution-yellow aqueous solution'
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Lucentis_RMP_RVO_Booklet_2021.pdf
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
First upload to medicines.ie
File name
Lucentis_RMP_CNV_Booklet_2021.pdf
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
First upload to medicines.ie
File name
Lucentis_RMP_AMD_Booklet_2021.pdf
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
First upload to medicines.ie
Updated on 17 October 2022
File name
Lucentis PFS REG SPC PF22-065 15.09.22_clean IPHA.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update Section 4.6 with the following information:
Based on very limited data, ranibizumab may be excreted in human milk at low levels. The effect of ranibizumab on a breast‑fed newborn/infant is unknown. As a precautionary measure, breast-feeding is not recommended during the use of Lucentis.
Updated on 17 October 2022
File name
Lucentis PFS REG PIL PF22-065 15.09.22_clean IPHA.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
Free text change information supplied by the pharmaceutical company
Update 'Pregnancy & Breastfeeding' section as follows:
Small amounts of Lucentis may pass into breast milk, therefore Lucentis is not recommended during breast-feeding.
Updated on 17 October 2022
File name
Lucentis PFS REG PIL PF22-065 15.09.22_clean IPHA.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
Free text change information supplied by the pharmaceutical company
Change to section 4.6 to include following information :
Breast-feeding
Based on very limited data, ranibizumab may be excreted in human milk at low levels. The effect of ranibizumab on a breast‑fed newborn/infant is unknown. As a precautionary measure, breast-feeding is not recommended during the use of Lucentis.
Updated on 28 July 2022
File name
Lucentis PFS_REG PIL_PF21-237 TBI 26 August 2022_clean.pdf
Reasons for updating
- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
Correction to UK(NI) contact details in Section 6
Updated on 08 December 2021
File name
Lucentis PFS_REG PIL_PF21-237 TBI 26 August 2022_clean.pdf
Reasons for updating
- Change to further information section
- Addition of information on reporting a side effect.
Free text change information supplied by the pharmaceutical company
Addition of Northern Ireland details
Updated on 08 December 2021
File name
Lucentis PFS REG SPC PF21-237 November 2021IPHA.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Addition of traceability statement to Section 4.4
Updated on 26 February 2020
File name
Lucentis PFS REG PIL PF19-161 TBI next order_IPHA.pdf
Reasons for updating
- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
Addition of Registered symbol
Updated on 30 October 2019
File name
Lucentis PFS PIL PF19-161 TBI next order_clean IPHA.pdf
Reasons for updating
- Change to section 1 - what the product is used for
Updated on 30 October 2019
File name
Lucentis PFS REG SPC PF19-161 Oct 2019 clean IPHA.pdf
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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updates to Sections 4.2, 4.2, 4.4, 4.8 and 5.1 following approval of a new indication for proliferative diabetic retinopathy (PDR)
Updated on 12 September 2018
File name
Lucentis PFS REG PIL_2213191_PF18-0118 TBI 30 March 2019_IPHA.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 30 August 2018
File name
Lucentis REG SPC PF18-238 July 2018 clean IPHA.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Addition of DRSS data to Section 5.1
Updated on 23 May 2018
File name
LucentisPFSREGSPC PF18-118April2018clean.docx
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- 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 28 February 2017
File name
PIL_11840_802.pdf
Reasons for updating
- New PIL for new product
Updated on 28 February 2017
Reasons for updating
- Change to section 1 - what the product is used for
- Change to information for healthcare professionals
Updated on 24 November 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 24 November 2016
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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
· Section 4.1: New indication wording that regroups the already approved indication “treatment of VA due to CNV secondary to PM” and this newly approved indication within one overall wording, i.e. “treatment of VA due to CNV”.
· Section 5.1: Description of the MINERVA study results in adults.
· Section 5.1: Description of the MINERVA study results in the 5 adolescent patients enrolled.
· Editorial changes to the SmPC to align with the latest QRD template
Updated on 21 June 2016
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5 - Pharmacological properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.4 - Removal of the warning related to patients presenting with prior episodes of RVO, ischaemic branch RVO and central RVO
was completely deleted. A statement was added under ‘Populations with limited data’, which reads: ‘There are insufficient data to conclude on the effect of Lucentis in patients with RVO presenting irreversible ischaemic visual function loss.’
Section 5.1 was updated to include long-term efficacy and safety data (BRIGHTER and CRYSTAL studies)
Updated on 04 November 2015
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 22 January 2015
Reasons for updating
- Change to marketing authorisation holder
- Change to dosage and administration
Updated on 17 December 2014
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 7 updated with new address of MAH.
Updated on 22 September 2014
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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 4.5 updated to reflect the RETAIN data including concomitant treatment with thiazolidinediones.
Section 4.8 updated to change IMB details to HPRA details following name change.
Section 5.1 of the SmPC revised to include study data from
· RETAIN 2 years data
· RESTORE extension 3 years data
Updated on 23 July 2014
Reasons for updating
- Addition of separate PILs covering individual presentations
Updated on 26 June 2014
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 11 June 2014
Reasons for updating
- New SPC for new product
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 April 2014
Reasons for updating
- Change to date of revision
- Change to dosage and administration
Updated on 29 November 2013
Reasons for updating
- Change to date of revision
- Changes to therapeutic indications
- Addition of information on reporting a side effect.
Updated on 03 July 2013
Reasons for updating
- Change of manufacturer
Updated on 20 February 2013
Reasons for updating
- Change to packaging
- Change to date of revision
Updated on 30 May 2012
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change to storage instructions
- Change to side-effects
Updated on 10 November 2011
Reasons for updating
- Change to dosage and administration
Updated on 11 July 2011
Reasons for updating
- Changes to therapeutic indications
Updated on 18 April 2011
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 06 May 2009
Reasons for updating
- Change to side-effects
Updated on 30 October 2008
Reasons for updating
- Change to dosage and administration
- Change to date of revision
Updated on 09 February 2007
Reasons for updating
- New PIL for new product