Key facts

Invented name
Lamzede
Active Substance
velmanase alfa
Therapeutic area
Endocrinology-Gynaecology-Fertility-Metabolism
Decision number
P/0407/2020
PIP number
EMEA-001056-PIP02-12-M01
Pharmaceutical form(s)
Powder for solution for injection
Condition(s) / indication(s)
Treatment of alpha-mannosidosis
Route(s) of administration
Intravenous use
Contact for public enquiries

Chiesi Farmaceutici S.p.A.

Tel. +39 0521 2791
E-mail: info@chiesi.com

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date
Compliance procedure number
EMEA-C-001056-PIP02-12-M01
Compliance opinion date
Compliance outcome
Positive

Decision

P/0407/2020: EMA decision of 23 October 2020 on the acceptance of a modification of an agreed paediatric investigation plan for velmanase alfa (Lamzede), (EMEA-001056-PIP02-12-M01)

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