Pergoveris (300 IU + 150 IU)/0.48 mL solution for injection in pre-filled pen
*Company:
MerckStatus:
UpdatedLegal 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 26 June 2025
File name
Pergoveris Pen 300_PIL IFU_IE_TW4921762.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Summary of changes:
* Needle Replacement: To replace the co-packaged CE marked B. Braun Pencylcap needles 29G x 12 mm used for Pergoveris
Solution for injection in pre-filled pen, with B. Braun Omnican fine pen needles 31G x 8 mm. The IFU are updated accordingly
with new images of needle as part of our Short Needles Project.
* IFU Format Change: Additionally, we will be changing the format of the Instructions for Use (IFU) from a booklet to a
leaflet, with the IFU now located on the back of the Package Leaflet as part of our LIFE Sustainability Project.
In addition, some other minor changes have been introduced:
o Editorial changes to the Package leaflet and IFU are introduced to better suit the leaflet format.
o Additional minor correction introduced in Package Leaflet (English language version) section 6.
o Update of Module 3 for the co-packaged needle according to Guideline on quality documentation for medicinal products when used with a medical device.
Updated on 07 June 2023
File name
Pergoveris (300 IU + 150 IU) 0.48 mL solution for injection in PFP-SPC-Clean-May 2023.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- 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
To extend the shelf-life, from 2 years to 3 years (SPC section 6.3)
Internal reference: TW 4028780
Updated on 07 June 2023
File name
Pergoveris Pen 300_SPC_IENI_TW4028780.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- 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
Internal reference number: TW4028780
Updated on 16 September 2022
File name
Pergoveris Pen 300_PIL IFU_IENI_TW3660155.pdf
Reasons for updating
- Improved presentation of PIL
Free text change information supplied by the pharmaceutical company
Update of instructions for use (IFU) at the end
(Our reference: TW3660155)
Updated on 16 December 2021
File name
Pergoveris Pen 300_PIL_IENI_TW3024307.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
Launch of 300 Pen in Ireland & implementation of label variation.
Our references: TW 3024307; TW 2908999
Updated on 16 December 2021
File name
Pergoveris Pen 300_SPC_IENI_TW3024307 2908999.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Launch of 300 Pen in Ireland & implementation of label variation.
Our references: TW 3024307; TW 2908999
Merck
Address:
Merck Serono (Ireland) Limited, 4045 Kingswood Road, Citywest Business Campus, Dublin 24, IrelandMedical Information E-mail:
medinfo.uk@merckgroup.comTelephone:
+353 1 468 7590Fax:
+353 1 466 3446Medical Information Facsimile:
+44 (0)208 818 7274Medical Information Direct Line:
+44 (0)208 818 7373