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: 26/04/18
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1. NAME OF THE MEDICINAL PRODUCT
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4. CLINICAL PARTICULARS
5. PHARMACOLOGICAL PROPERTIES
5. PHARMACOLOGICAL PROPERTIES
6. PHARMACEUTICAL PARTICULARS
6. PHARMACEUTICAL PARTICULARS
7. MARKETING AUTHORISATION HOLDER
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
10. DATE OF REVISION OF THE TEXT
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 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 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 28 March 2017 SmPC
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
|
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 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 SmPC
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 SmPC
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 SmPC
Reasons for updating
- New individual SPC (was previously included in combined SPC)
Legal category: Product subject to medical prescription which may be renewed (B)
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)