Inspra 25mg Film-Coated Tablets
*Company:
Upjohn EESVStatus:
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 30 May 2023
File name
PATIEN~1.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 30 November 2021
File name
DEC202115396-V_Reg SPC IN 25mg 15_1 IE - clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
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 follows:
Section 7 - Pfizer Healthcare Ireland changed to Upjohn EESV as the MAH, with updated address
Section 8 - updated with new PA number for Upjohn EESV
Updated on 30 November 2021
File name
DEC202115396-V_Reg PIL IN 20_0 25mg &50mg IE - clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 06 April 2021
File name
DEC202052325-V_Reg SPC IN 25mg 14_1 IE - clean.pdf
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
|
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
|
Updated on 06 April 2021
File name
DEC202052325-V_Reg PIL IN 19_3 25mg &50mg IE - clean.pdf
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 12 February 2021
File name
DEC202102017-V_Reg SPC IN 25mg 13_1 IE - clean.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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 follows:
Section 4.5 - NSAID interaction text updated to provide additional medical guidance
Updated on 13 November 2020
File name
Reg PIL IN 18_0 25mg &50mg IE - clean.pdf
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
File name
Reg PIL IN 17_1 UK & IE-clean.pdf
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 06 November 2017
File name
PIL_9192_955.pdf
Reasons for updating
- New PIL for new product
Updated on 28 March 2017
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
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
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 03 November 2015
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 03 November 2015
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 27 January 2015
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
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 04 September 2013
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
section 4.2 to include statement on paediatric population
Section 4.3 ,4.5, 4.6, 4.8 update in line with QRD
Section 5.1 and 5.2 update on studies in paediatric population
Updated on 04 September 2013
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Free text change information supplied by the pharmaceutical company
section 4.2 to include statement on paediatric population
Section 4.3 ,4.5, 4.6, 4.8 update in line with QRD
Section 5.1 and 5.2 update on studies in paediatric population
Updated on 13 April 2012
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- 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 4.7 - Effects on ability to drive and use machines
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.2 Posology and method of administration
Section 4.3 Contraindications
Section 4.4 Special warnings and precautions for use
Section 4.5 Interaction with other medicinal products and other forms of interaction
Section 4.7 Undesirable effects
Section 5.1 Pharmacodynamic properties
Updated on 13 April 2012
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- 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 4.7 - Effects on ability to drive and use machines
- Change to section 5.1 - Pharmacodynamic properties
Free text change information supplied by the pharmaceutical company
Section 4.2 Posology and method of administration
Section 4.3 Contraindications
Section 4.4 Special warnings and precautions for use
Section 4.5 Interaction with other medicinal products and other forms of interaction
Section 4.7 Undesirable effects
Section 5.1 Pharmacodynamic properties
Updated on 01 April 2010
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 2 was updated to include information about lactose
Updated on 01 April 2010
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
Free text change information supplied by the pharmaceutical company
Section 2 was updated to include information about lactose
Updated on 28 February 2008
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
4.8 – Addition of a paragraph to provide further explanation as to the genesis of adverse events (i.e., from
Reordering of some of the undesirable effects including with NO change to the information:
i) Infections and infestations
ii) Metabolism and nutrition disorders
iii) Cardiac disorders
iv) Vascular disorders
v) Gastrointestinal disorders
Updated on 28 February 2008
Reasons for updating
- Change to section 4.8 - Undesirable effects
Free text change information supplied by the pharmaceutical company
4.8 – Addition of a paragraph to provide further explanation as to the genesis of adverse events (i.e., from
Reordering of some of the undesirable effects including with NO change to the information:
i) Infections and infestations
ii) Metabolism and nutrition disorders
iii) Cardiac disorders
iv) Vascular disorders
v) Gastrointestinal disorders
Updated on 31 August 2006
Reasons for updating
- Change to section 6.1 - List of excipients
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 31 August 2006
Reasons for updating
- Change to section 6.1 - List of excipients
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
Free text change information supplied by the pharmaceutical company
Updated on 14 September 2005
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 14 September 2005
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Updated on 24 March 2005
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 24 March 2005
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Updated on 01 November 2004
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 01 November 2004
Reasons for updating
- New SPC for new product