Clinical reports for Galafold - Initial marketing authorisation

All information published on the website is correct at the time of publication. For the current status of this product, please see 'Find medicine' on the EMA website.

Product name
Galafold
MAH
Amicus Therapeutics UK Ltd
Active substance
MIGALASTAT
ATC code
AI6AX14
Number of Documents
0
Procedure type
Initial marketing authorisation
Publication year
2018
Product Status
Authorised
Type
Article 58
No
EMA procedure number
EMEA/H/C/004059/0000
See the European Public Assessment Report (EPAR) on the EMA website

For Clinical Study Reports with data from studies AT1001-011 and AT1001-012 The documents you are trying to access are not currently available on this website. Please note that the marketing authorisation holder has filed with the General Court an action for annulment of the Agency's decision to release Clinical Study Report AT1001-011 further to a request for access to documents under Regulation (EC) No 1049/2001. Since the marketing authorisation holder had also filed an application for interim relief before the General Court, and in light of the case-law of the Court of Justice concerning interim orders, the Agency eventually agreed to suspend the processing of requests under Regulation (EC) No 1049/2001 for access to the Clinical Study Reports AT1001-011 and AT1001-012. Consequently, the Agency is not currently in a position to make clinical study reports with data from studies AT1001-011 and AT1001-012 publicly available in accordance with its Policy on the publication of clinical data (Policy 0070). For all other Clinical Study Reports The documents you are trying to access are not currently available on this website. Please note that the marketing authorisation holder has filed with the General Court an action for annulment of the Agency's decision to release Clinical Study Report AT1001-011 further to a request for access to documents under Regulation (EC) No 1049/2001. Since the marketing authorisation holder had also filed an application for interim relief before the General Court, and in light of the case-law of the Court of Justice concerning interim orders, the Agency eventually agreed to suspend the processing of requests under Regulation (EC) No 1049/2001 for access to the Clinical Study Reports AT1001-011 and AT1001-012. In the view of the Agency, this decision to suspend the processing of requests under Regulation (EC) No 1049/2001 for access to the Clinical Study Reports AT1001-011 and AT1001-012 is without prejudice to the implementation of its Policy on the publication of clinical data (Policy 0070) to all other Clinical Study Reports for the medicinal product Galafold. However, the marketing authorisation holder is of the different view that the Agency should not publish any and all Clinical Study Reports related to Galafold. For this reason, the marketing authorisation holder has not provided the Agency with the documents you are trying to access.