Lumigan 0.1mg/ml
*Company:
AbbVie LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 26 July 2022
File name
ie-lumigan-pil-0.1-v16-clean.pdf
Reasons for updating
- Change to MA holder contact details
- Change to date of revision
Updated on 24 May 2022
File name
Lumigan 0.1 SPC.pdf
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 be renewed (B)
Updated on 24 May 2022
File name
Lumigan 0.1 PIL.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 23 February 2022
File name
Lumigan 0.1 PIL V14.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 04 January 2022
File name
Lumigan 0.1 PIL V14.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 6 - date of revision
Updated on 04 January 2022
File name
Lumigan 0.1 SPC V9.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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 be renewed (B)
Updated on 07 July 2021
File name
Lumigan 0.1 PIL clean - v13.pdf
Reasons for updating
- Change to other sources of information section
Updated on 18 May 2020
File name
Lumigan 0.1 PIL - v12.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 02 April 2019
File name
Lumigan 0.1 PIL UK + IE+ MT - v11.pdf
Reasons for updating
- Change to other sources of information section
Updated on 01 February 2019
File name
Lumigan 0.1 PIL UK+IE+MT-V10.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 01 February 2019
File name
Lumigan 0.1 SPC IE-V8.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 be renewed (B)
Free text change information supplied by the pharmaceutical company
In section 4.8 (undesirable effects), the adverse reactions dizziness, ocular discomfort photophobia, skin discoloration (periocular) and hypertension were added (frequency not known).
In section 10 (date of revision of text), the revised date was updated to 01/2019.
Updated on 28 June 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 28 June 2017
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 be renewed (B)
Free text change information supplied by the pharmaceutical company
In section 10 (Date of revision of the text) - date of revision of the text is May 2017 (05/2017).
Updated on 26 June 2017
File name
PIL_14624_824.pdf
Reasons for updating
- New PIL for new product
Updated on 26 June 2017
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 07 April 2016
Reasons for updating
- Change to section 10 - Date of revision of the text
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- addition of the following adverse reactions under the SOC (system organ class) Eye disorders with a frequency not known: blepharal pigmentation, macular oedema, periorbital and lid changes including deepening of the eyelid sulcus and dry eye;
- addition of the following adverse reactions under the SOC Immune system disorders with a frequency not known: hypersensitivity reaction including signs and symptoms of eye allergy and allergic dermatitis.
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
In section 4.8 (undesirable effects):
Table 1:
- addition of the following adverse reactions under the SOC (system organ class) Eye disorders with a frequency not known: blepharal pigmentation, macular oedema, periorbital and lid changes including deepening of the eyelid sulcus and dry eye;
- addition of the following adverse reactions under the SOC Immune system disorders with a frequency not known: hypersensitivity reaction including signs and symptoms of eye allergy and allergic dermatitis.
Table 2 - removed enophthalmos from the SOC Eye disorders with a frequency not known
In section 10 (date of revision of the text) - new revision date is 03/2016.
Updated on 06 April 2016
Reasons for updating
- Change to side-effects
- Addition of information on reporting a side effect.
Updated on 16 March 2016
Reasons for updating
- Change to date of revision
- Change to improve clarity and readability
Updated on 09 February 2016
Reasons for updating
- Previous version of SPC reinstated
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 04 February 2016
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
In section 4.8 (undesirable effects) addition of the following adverse reactions under System Organ class (SOC) Immune system disorders with a frequency not known: Hypersensitivity reaction including signs and symptoms of eye allergy and allergic dermatitis." ; addition of the following adverse reactions under the SOC Eye disorders with a frequency not known in Table 1: blepharal pigmentation, macular oedema, periorbital and lid changes including deepening of the eyelid sulcus, dry eye; removal of the "enophthalmos" adverse reaction from the SOC Eye disorders with the frequency not known in Table 2.
In section 10 (date of revision of the text) the new date of the revision of the text is 01/2016.
Updated on 09 July 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 13 August 2014
Reasons for updating
- Change to side-effects
- Change to marketing authorisation holder
Updated on 30 January 2014
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.4 of the SPC now include new text to warn about reports of exacerbation of asthma, dyspnea and COPD, as well as reports of asthma, in post marketing experience. Patients with COPD, asthma or compromised respiratory function due to other conditions should be treated with caution. In addition, asthma, asthma exacerbation, COPD exacerbation and dyspnea were added to section 4.8 of the SPC.
Updated on 22 January 2014
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 04 November 2013
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 - 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Updating "Excipients" to read "Excipients with known effect"
Sec. 4.2 Posology and method of administration
Updating "USe in hepatic and renal impairment" to read "Patients with hepatic and renal impairment".
Sec.4.4 Special warnings and precautions for use
Updating "The tip of the bottle should not be allowed to contact the eye, surrounding structures, fingers or any other surface in order to avoid contamination of the solution" to read "Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures, to avoid eye injury and contamination of the solution".
Sec. 4.6 Heading updated from "Pregnancy and lactation" to "Fertility, pregnancy and lactation".
4.8 Undesirable effects
- moving the side effects in the table
- adding ADR reporting statement
- inclusion of PhWVP warning wording for phosphate containing eyedrops
10. DATE OF REVISION OF THE TEXT
Updating revision date from July 2012 to 09/2012
Updated on 21 October 2013
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
- Change of special precautions for disposal
- Addition of marketing authorisation holder
- Addition of information on reporting a side effect.
Updated on 26 February 2013
Reasons for updating
- Change to MA holder contact details
- Correction of spelling/typing errors
Updated on 02 August 2012
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
· 4.4 Special Warnings and Precautions section of the SmPC:
§ iris hyperpigmentation is likely to be permanent (as opposed to may be permanent)
§ hair growth precaution
§ information relating the more frequent than once a daily administration of bimatoprost
§ information relating to bacterial keratitis with multidose containers
· 4.5 Interactions with other medicinal products section
§ information relating to a lack of information on concomitant use of bimatoprost with other prostaglandin analogues
· 4.8 Undesirable effects section
§ ‘eye pain’ was added as adverse reaction with Lumigan 0.1 mg/ml
§ ‘periorbital erythema’ with Lumigan 0.3 mg/ml
§ ‘blurred vision’ added to the list of common adverse effects for Lumigan 0.3 mg/ml
There are also a number of administrative changes.
Updated on 27 July 2012
Reasons for updating
- Change to side-effects
- Change to drug interactions
- Change of contraindications
Updated on 25 July 2011
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
Updated on 06 July 2011
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Summary of Changes to Lumigan® 0.1mg/ml Summary of Product Characteristics (SPC)
The current Lumigan® 0.1mg/ml is dated 21st January 2011
This supersedes SPC dated 7th January 2010
|
Section Number |
Subject |
Change |
|
10 |
DATE OF REVISION OF THE TEXT |
Text Removed/Added
|
Key:
Unchanged text appears as follows: eg Paediatric population
Added text appears as follows: eg Uveitis
Deleted (Removed) text appears as follows: eg Not applicable
Updated on 05 July 2011
Reasons for updating
- Change to MA holder contact details
Updated on 31 March 2010
Reasons for updating
- New PIL for new product
Updated on 30 March 2010
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)