Previous SPC Harmonisation rounds

Name of VMPName of the active substanceName of MAHRMS StatusProduct Information

 

2nd round

 

 RECEPTALBuserelin acetateIntervetIEConcluded on 15 August 2025eu-pi-combined-receptal

SYNULOX TABLETS (3 strength)

SYNULOX DROPS 

Amoxicillin trihydrate and Potassium clavulanateZoetisDEConcluded on 13 October 2025

spc-pi-synulox-drops

spc-pi-synulox-tablets-50mg

spc-pi-synulox-tablets-250mg

spc-pi-synulox-tablets-500mg

Please find the list with related products of the 2nd round here.

 

1st round

CatosalButafosfan, CyanocobalaminElancoDE-BVL

Concluded on 06 April 2024

Harmonisation of part II closed on 26 May 2024

 

eu-pi-combined-catosal 

FinadyneFlunixine meglumineMerckESConcluded on 20 July 2024eu-pi-combined-finadyne
EstrumateCloprostenolIntervetFRConcluded on 23 July 2024eu-pi-combined-estrumate
DomosedanDetomidine hydrochlorideOrionIEConcluded on 10 April 2024

Harmonisation of part II closed on 2 May 2024

eu-pl-domosedan-10-mg-ml-inject

eu-lab-domosedan-10-mg-ml-inject

eu-spc-domosedan-10-mg-ml-inject

PlanateCloprostenolMerckNLConcluded on 22 July 2024eu-pi-combined-planate

Please find the list with related products of the 1st round here.