Gallagher schreef op 22 november 2018 14:27:
EMA rapport October:
Opinions on modifications to an agreed PIP
The PDCO also adopts, every month, opinions on modifications to an agreed PIP, which can be requested by the applicant when the plan is no longer appropriate or when there are difficulties that render the plan unworkable. The PDCO adopted positive opinions, agreeing change(s), for the following products:
Conestat alfa, EMEA-000367-PIP01-08-M08, from Pharming Group N.V., for the treatment of hereditary angioedema (HAE);
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