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Pharmaceuticals - Community Register


List of Orphan refusals for human medicinal products

Midazolam Hydrochloride (oromucosal use)

Product name: Midazolam Hydrochloride (oromucosal use)
Active substance: Midazolam hydrochloride (oromucosal use)
Indication: Treatment of seizures which continue for at least five minutes
Marketing Authorisation Holder: Special Products Ltd

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
02/03/2004 Refusal of orphan designation EMEA/OD/025/03 (2004)356 of 01/03/2004