Pergoveris (300 IU + 150 IU)/0.48 mL solution for injection in pre-filled pen

*
Pharmacy Only: Prescription
  • Company:

    Merck
  • Status:

    Updated
  • 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

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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

Merck