Pergoveris (900 IU + 450 IU)/1.44 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 900_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 (900 IU + 450 IU) 1.44 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 900_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 900_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 13 April 2022
File name
Pergoveris Pen 900_PIL_IENI_TW3024307.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Implementation of label variation.
Our references: TW 3024307
(reupload)
Updated on 16 December 2021
File name
Pergoveris Pen 900_SPC_IENI_TW3024307.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- To update sections 3, 4.1, 4.2, 4.4, 5.1, 5.2 and 6.6 of the SmPC in order to revise the definition of severe LH and FSH deficiency and further amendments, based on current medical guidelines, clinical practice and literature
- Our references: TW 3024307
Updated on 02 September 2019
File name
PL Pergoveris Pen - MAH transfer.pdf
Reasons for updating
- New PIL for new product
Updated on 02 September 2019
File name
Pergoveris Pen IE TW1319935 current V1.0.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
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