The European Medicines Agency has recommended the refusal of a change to the marketing authorisation for Emgality. The change concerned an extension of indication to add prevention of attacks in adults who suffer from episodic cluster headache. For this use, Emgality was to be available as a pre-filled syringe containing 100 mg of the medicine.
The Agency issued this opinion on 27 February 2020.
The company that applied for the change to the authorisation, Eli Lilly Nederland B.V, may ask for re-examination of the opinion within 15 days of receiving the opinion.
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This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.
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