cteristics, section 4.2).
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
AUTHORISATION
• Periodic Safety Update Reports
The requirements for submission of periodic safety update reports for this medicinal product are setout in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive2001/83/EC and any subsequent updates published on the European medicines web-portal.
The marketing authorisation holder shall submit the first periodic safety update report for this productwithin 6 months following authorisation.
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
EFFECTIVE USE OF THE MEDICINAL PRODUCT
• Risk Management Plan (RMP)
The MAH shall perform the required pharmacovigilance activities and interventions detailed in theagreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent
updates of the RMP.
An updated RMP should be submitted:
• At the request of the European Medicines Agency;
• Whenever the risk management system is modified, especially as the result of new informationbeing received that may lead to a significant change to the benefit/risk profile or as the result ofan important (pharmacovigilance or risk minimisation) milestone being reached.
E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES
FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL
CIRCUMSTANCES
This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation
(EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
Description Due date
In order to obtain long-term data on effectiveness and safety of treatment with
Lamzede and to characterize the entire alpha-mannosidosis population, including
variability of clinical manifestation, progression and natural history, the MAH is
requested to submit the results of a study based on adequate source of data
deriving from a registry of patients with alpha-mannosidosis.
Annual reports
to be submitted
as part of the
annual reassessment
Paediatric Study rhLAMAN-08. A 24 month multi-center, open label phase IItrial investigating the safety and efficacy of repeated velmanase alfa (recombinanthuman alpha-mannosidase) treatment in paediatric patients <6 years of age withalpha-mannosidosis.
Final Study
report:
November 2020
https://www.ema.europa.eu/en/documents/product-information/lamzede-epar-product-information_en.pdf |
