Pharmaceuticals - Community Register


List of nationally authorised medicinal products for human use


Product name: Nicardipine
Also marketed in the EU under the name(s): Nicardipine hydrochloride
Active substance: nicardipine
Indication: Intravenous nicardipine [or invented name] is indicated for the treatment of acute life-threatening hypertension, particularly in the event of:
• Malignant arterial hypertension/Hypertensive encephalopathy
• Aortic dissection, when short acting beta-blocker therapy is not suitable, or in combination with a beta-blocker when beta-blockade alone is not effective
• Severe pre-eclampsia, when other intravenous antihypertensive agents are not recommended or are contra-indicated
Nicardipine is also indicated for the treatment of post-operative hypertension
Marketing Authorisation Holder: Not applicable

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
06/01/2014 Referral EMEA/H/A-31/1339 (2014)9824 of 20/12/2013