My HPRA: Register

The HPRA advises healthcare professionals not to retain printed versions of Summary of Product Characteristics (SPC) documents. As these documents are subject to frequent content updates, including changes to safety and dose related information, we recommend that you visit our website as necessary to access the most up-to-date versions. If you have any queries about specific SPCs on our website then please e-mail info@hpra.ie


Rekovelle



Ferring Pharmaceuticals A/SEU/1/16/1150/005

Main Information

Trade NameRekovelle
Active SubstancesFollitropin delta
Dosage FormSolution for injection
Licence HolderFerring Pharmaceuticals A/S
Licence NumberEU/1/16/1150/005

Group Information

ATC CodeG03GA Gonadotropins
G03GA10 Follitropin Delta

Status

License statusAuthorised
Licence Issued12/12/2016
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Marketing StatusUnknown

Documents

Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website
« Back
Follow medicine

Print