INSPRA 50 mg film-coated tablets. *
Pharmacy Only: Prescription

  • Company:

    Pfizer Healthcare Ireland
  • Status:

    Updated
  • Legal 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

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 30 November 2021

File name

DEC202115396-V_Reg SPC IN 50mg 15_1 IE - clean_1638255938.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_1638255910.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 50mg 14_1 IE - clean_1617701692.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_1617701636.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 13 November 2020

File name

Reg PIL IN 18_0 25mg &50mg IE - clean_1605259791.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

  • 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 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 02 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 02 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 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

Update to section 4.8, change of frequency of some side effects within the SOC and reporting information.

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

Update to section 4.8, change of frequency of some side effects within the SOC and reporting information.

Updated on 04 September 2013

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

None provided

Updated on 04 September 2013

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

Free text change information supplied by the pharmaceutical company

None provided