Lorviqua 25mg & 100mg Film Coated Tablets
*Company:
Pfizer Healthcare IrelandStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 15 January 2024
File name
ADVSPCLQ111IEclean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The following changes to the labeling have been approved. Please refer to attached copy/copies of labeling documentation for full details.
The SPC has been updated as follows:
Section 4.8: Addition of the common ADR ‘Proteinuria’.
Updated on 15 January 2024
File name
ADVPILLQ112IENIclean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 18 April 2023
File name
ADVSPCLQ100IEclean.pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- 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 11 May 2022
File name
ADVSPCLQ90IEclean.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 11 May 2022
File name
ADVSPCLQ90IEclean.pdf
Reasons for updating
- Change to section 6.4 - Special precautions for storage
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows: Section 6.4 removal of pack size. Section 8 removal of pack size license number.
Updated on 11 May 2022
File name
ADVPILLQ100IENIclean.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
Updated on 02 February 2022
File name
ADVSPCLQ81IEclean.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
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
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The SPC IE and SPC NI has been updated as follows: - section 4.1 Therapeutic indications to include the following statement; Lorviqua as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor. - Addition of text in section 4.2 Posology and method of administration related to ALK testing - Amendment of ‘days range’ in section 4.4. for ‘Hyperlipidaemia’ and ‘Lipase and Amylase increase’ - Addition of data from B7461006 (CROWN) study in section 4.8 - Addition of data from B7461006 (CROWN) study in section 5.1 Pharmacodynamic properties - Additional elimination and renal impairment statement added to section 5.2
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Updated on 02 February 2022
File name
ADVPILLQ90IENIclean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 6 - date of revision
Updated on 10 November 2021
File name
ADV PIL LQ 7_0 IE & NI - clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Individual PILs superseded by joint PIL
Updated on 09 November 2021
File name
ADV PIL LQ 7_0 IE & NI - clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Individual PILs superseded by joint PIL
Updated on 05 August 2021
File name
DEC202153379_ADV SPC LQ 7_0 IE - clean.pdf
Reasons for updating
- 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
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- 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
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The SPC has been updated as follows: sections 4.2, 4.4 and 4.8 addition of Hypertension and Hyperglycaemia; section 5.1 updated ATC code; section 9 date of latest Renewal; section 10 date of revision and Ref number. |
Updated on 05 August 2021
File name
DEC202153379_ADV PIL LQ 7_0 IE - clean.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 19 March 2021
File name
DEC202119422_ADV SPC LQ 6_0 IE - clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.2 - Pharmacokinetic properties
- 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 19 March 2021
File name
DEC202119422_ADV PIL LQ 6_0 IE - clean.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 23 December 2020
File name
DEC202086611_ADV SPC LQ 5_0 IE - clean.pdf
Reasons for updating
- 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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 23 December 2020
File name
DEC202086611_ADV PIL LQ 5_0 IE - clean.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 01 October 2020
File name
ADV PIL LQ 4_0 IE clean.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 05 June 2020
File name
DEC202037002_ADV SPC LQ 4-0 IE clean.pdf
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
- Change to section 5.2 - Pharmacokinetic properties
- 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 23 January 2020
File name
ADV SPC LQ 3-0 IE clean.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
In section 6.3 the shelf-life has changed from 2 years to 3 years
Updated on 23 January 2020
File name
ADV PIL LQ 3-0 IE clean.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 01 October 2019
File name
DEC201951059_ADV SPC LQ 2_0 IE-clean.pdf
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
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Product to be launched 1st October 2019 |
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New SPC to reflect the new Pfizer Marketing Authorisation |
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New PIL to reflect the new Pfizer Marketing Authorisation |
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Updated on 01 October 2019
File name
DEC201951059_ADV PIL LQ 2_0 IE-clean.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
PIL for Newly Marketed Product - launched 01 October 2019