NutropinAq
*Company:
Ipsen Pharmaceuticals LimitedStatus:
DiscontinuedLegal 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
Updated on 19 May 2022
File name
220302A ni-ie-pl-clean_21_NUT.pdf
Reasons for updating
- Change to further information section
Free text change information supplied by the pharmaceutical company
The section "NutropinAq Pen: Instructions for use with NutropinAq" has been updated with more detailed Storage and Maintenance instructions.
Updated on 03 March 2021
File name
210218A_ukie-pl-clean-18_NUT.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.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.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.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.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.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.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.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
File name
PIL_12612_490.pdf
Reasons for updating
- New PIL for new product
Updated on 08 April 2016
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 28 May 2014
Reasons for updating
- Correction of spelling/typing errors
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 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
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
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