INSPRA 50 mg film-coated tablets.
- Name:
INSPRA 50 mg film-coated tablets.
- Company:
Pfizer Healthcare Ireland
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 06/04/21
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Pfizer Healthcare Ireland
Company Products
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 6 April 2021 SPC
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.4 - Special warnings and precautions for use
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
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The SPC has been updated as follows: Section 3 – Pharmaceutical form to included (tablet). Section 4.4 – Rewording of lactose warning and addition of sodium warning
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Updated on 6 April 2021 PIL
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 13 November 2020 PIL
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
- Joint PIL superseded by individual PILs
Updated on 26 April 2018 PIL
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 6 November 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 28 March 2017 SPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.3 - Contraindications
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
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Approved changes are in line with Work sharing NL/H/xxxx/WS/189 The following changes to the labelling have been approved. Please refer to attached copies of labelling documentation for full details. |
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The SPC is updated in sections 4.2, 4.3, 4.5, 5.1, 5.2, 5.3 and editorial. The PIL has been updated in section 2 and 4. See PIL tick list for sections updated. The PI is affected. The packaging (label/carton) are not affected Implementation Responsibilities – Brand Marketing SPC Ireland Brand Marketing Please implement in line with REG08-WI-IRL02 Generation and update of promotional material with regulatory license change Affected
PI Ireland Brand Marketing Please implement in line with REG08-WI-IRL02 Generation and update of promotional material with regulatory license change Affected |
Updated on 28 March 2017 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 28 March 2017 PIL
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.3 - Contraindications
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
Free text change information supplied by the pharmaceutical company
|
Approved changes are in line with Work sharing NL/H/xxxx/WS/189 The following changes to the labelling have been approved. Please refer to attached copies of labelling documentation for full details. |
|
The SPC is updated in sections 4.2, 4.3, 4.5, 5.1, 5.2, 5.3 and editorial. The PIL has been updated in section 2 and 4. See PIL tick list for sections updated. The PI is affected. The packaging (label/carton) are not affected Implementation Responsibilities – Brand Marketing SPC Ireland Brand Marketing Please implement in line with REG08-WI-IRL02 Generation and update of promotional material with regulatory license change Affected
PI Ireland Brand Marketing Please implement in line with REG08-WI-IRL02 Generation and update of promotional material with regulatory license change Affected |
Updated on 2 November 2015 PIL
Reasons for updating
- Change to section 4.8 - Undesirable effects
Free text change information supplied by the pharmaceutical company
The SPC has been updated as Follow:
The SPC has been updated in section 4.8 to delete myocardial infarction
Updated on 2 November 2015 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as Follow:
The SPC has been updated in section 4.8 to delete myocardial infarction
Updated on 27 January 2015 SPC
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 27 January 2015 PIL
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Free text change information supplied by the pharmaceutical company
Updated on 4 September 2013 PIL
Reasons for updating
- New individual SPC (was previously included in combined SPC)
Free text change information supplied by the pharmaceutical company
Updated on 4 September 2013 SPC
Reasons for updating
- New individual SPC (was previously included in combined SPC)
Legal category: Product subject to medical prescription which may be renewed (B)