[A18-22] Glycopyrronium bromide (sialorrhoea) - Benefit assessment according to §35a Social Code Book V

Last updated 02.07.2018

Project no.:
A18-22

Commission:
Commission awarded on 29.03.2018 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Application field:
Children's and adolescents' health

Indication:

Severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders

Result of dossier assessment:

Added benefit not proven as the appropriate comparator therapy (best supportive care) was not implemented in any of the studies

Note:

After completion of the assessment by IQWiG the Federal Joint Committee (G-BA) conducts a commenting procedure. This may provide supplementary information and as a result lead to a modified benefit assessment. Further information and the decision on the early benefit assessment can be found on the relevant page of the G-BA website.

Federal Joint Committee (G-BA)

2018-09-20 A G-BA decision was published.

G-BA documents on this decision

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