NutropinAq *
Pharmacy Only: Prescription

  • Company:

    Ipsen Pharmaceuticals Limited
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • 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 03 March 2021

File name

210218A_ukie-pl-clean-18_NUT_1614798275.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

PIL

2_What you need to know before you use NutropinAq

 

The Warnings and Precautions information within section 2 has been updated to include additional information related to symptoms of pancreatitis.

 

4_Possible side effects

The list of uncommon side effects has been updated to include breast enlargement (gynaecomastia). Gynaecomastis has been removed from the rare side effects list.

 

Reporting side effects:

The section on reporting side effects has been updated to match the most recent QRD Appendix V template.

Updated on 03 March 2021

File name

210218A_ukie-pl-clean-18_NUT_1614795428.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 4 - how to report a side effect
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Please see below for details of the changes affecting the PIL:

2. What you need to know before you use NutropinAq

The Warnings and Precautions information within section 2 has been updated to include additional information related to symptoms of pancreatitis.

4. Possible side effects

The list of uncommon side effects has been updated to include breast enlargement (gynaecomastia). Gynaecomastis has been removed from the rare side effects list.

Reporting side effects:

The section on reporting side effects has been updated to match the most recent QRD Appendix V template.

Updated on 03 March 2021

File name

210218A_ukie-spc-clean-17_NUT_1614795200.pdf

Reasons for updating

  • 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)

Free text change information supplied by the pharmaceutical company

Please see below for details of the changes:

4.4 Special warnings and precautions for use:

A warning on Slipped capital femoral epiphysis has been added to section 4.4 under a separate paragraph.

The paragraph previously named “Pancreatitis in children” has been updated as this warning also applies to adults.

4.8 Undesirable effects

The section on reporting of suspected adverse reactions has been updated to match the most recent QRD Appendix V template.

Updated on 19 February 2020

File name

200121A ukie-pl-clean-16_NUT_1582126970.pdf

Reasons for updating

  • Change of distributor details
  • Correction of spelling/typing errors
  • Change to date of revision

Free text change information supplied by the pharmaceutical company

Update to local representatives, update of reporting details in section 6

Updated on 19 February 2020

File name

200121A ukie-spc-clean-15_NUT_1582126733.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Correction of spelling/typing errors

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to local representatives on PIL and update of SmPC as per QRD template v10.1

Updated on 10 January 2019

File name

180906A_ukie_pl_cl_13_NUT_UKIE_updated 190107_1547125825.pdf

Reasons for updating

  • Change to section 6 - what the product contains

Updated on 14 September 2018

File name

180906A_ukie_pl_cl_13_NUT_UKIE_1536929556.pdf

Reasons for updating

  • Change to other sources of information section
  • Improved presentation of PIL

Updated on 14 September 2018

File name

180906A_ie-spc-cl_11_NUT_IE_1536929752.pdf

Reasons for updating

  • Improved presentation of SPC

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to SmPC in line with QRD version 10-formatting changes only.

Updated on 11 May 2018

File name

180222-ie-spc-cl_8_NUT_IE.docx

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 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

Section 4.2: addition of wording relating to women on oestrogen therapy and growth therapy interactions

Section 4.4: addition of warning relating to women on oestrogen therapy

Section 4.5: addition of wording relating to interaction of oestrogen therapy and growth hormones

Updated on 04 May 2018

File name

180222_uk_pl_cl_9_NUT_UK&IE.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 08 April 2016

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 08 April 2016

File name

PIL_12612_490.pdf

Reasons for updating

  • New PIL for new product

Updated on 28 May 2014

Reasons for updating

  • Correction of spelling/typing errors

Updated on 04 June 2013

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

$0The changes are quite extensive, although the majority are to bring the text into line with the latest EU regulatory product information templates (QRD templates) and EU SmPC Guideline.$0$0There has also been one new post-marketing AE added (adenoidal hypertrophy).$0

Updated on 04 June 2013

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 31 May 2013

Reasons for updating

  • Change to side-effects

Updated on 26 January 2012

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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.2 - Incompatibilities
  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

$0Minor changes are required to section:       4.2, 4.6 (heading), 6.2 (typo).$0$0Major changes are required to sections      4.4, 4.5, 4.8,  7$0

Updated on 26 January 2012

Reasons for updating

  • Change due to user-testing of patient information

Updated on 27 May 2010

Reasons for updating

  • Improved electronic presentation

Updated on 28 August 2008

Reasons for updating

  • Change to date of revision

Updated on 27 August 2008

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 18 October 2007

Reasons for updating

  • New PIL for new product