Lucentis 10mg/ml solution for injection in pre-filled syringe

  • Name:

    Lucentis 10mg/ml solution for injection in pre-filled syringe

  • Company:
    info
  • Active Ingredients:

    Ranibizumab

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 30/10/19

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Summary of Product Characteristics last updated on medicines.ie: 30/10/2019

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Novartis Ireland Limited

Novartis Ireland Limited

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1 - 0 of 116 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 30 October 2019 PIL

Reasons for updating

  • Change to section 1 - what the product is used for

Updated on 30 October 2019 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 4.8 - 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 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 30 August 2018 SmPC

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 SmPC

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 PIL

Reasons for updating

  • New PIL for new product

Updated on 28 February 2017 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to information for healthcare professionals

Updated on 24 November 2016 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 4.8 - 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 24 November 2016 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 June 2016 SmPC

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 4 November 2015 SmPC

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

Shortening of the text and minor editorial changes to improve clarity

Updated on 22 January 2015 PIL

Reasons for updating

  • Change to marketing authorisation holder
  • Change to dosage and administration

Updated on 17 December 2014 SmPC

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 6.3 updated to reflect new shelf life of 3 years.
Section 7 updated with new address of MAH.

Updated on 22 September 2014 SmPC

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 4.2 of the SmPC updated to improved treatment recommendations and to harmonize the administration instructions across all indications.

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 PIL

Reasons for updating

  • Addition of separate PILs covering individual presentations

Updated on 26 June 2014 SmPC

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

Section 4.4 updated to read: Limited data on bilateral use of Lucentis (including same-day administration) do not suggest an increased risk of systemic adverse events compared with unilateral treatment.

Updated on 11 June 2014 SmPC

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

None provided

Updated on 24 April 2014 PIL

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration

Updated on 29 November 2013 PIL

Reasons for updating

  • Change to date of revision
  • Changes to therapeutic indications
  • Addition of information on reporting a side effect.

Updated on 3 July 2013 PIL

Reasons for updating

  • Change of manufacturer

Updated on 20 February 2013 PIL

Reasons for updating

  • Change to packaging
  • Change to date of revision

Updated on 30 May 2012 PIL

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 PIL

Reasons for updating

  • Change to dosage and administration

Updated on 11 July 2011 PIL

Reasons for updating

  • Changes to therapeutic indications

Updated on 18 April 2011 PIL

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 6 May 2009 PIL

Reasons for updating

  • Change to side-effects

Updated on 30 October 2008 PIL

Reasons for updating

  • Change to dosage and administration
  • Change to date of revision

Updated on 9 February 2007 PIL

Reasons for updating

  • New PIL for new product