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H. ANNEX H - Product Shared Mailboxes – e-mail address ......................... 66<br />
A. PRE SUBMISSION ISSUES<br />
A.1. ELIGIBILITY REQUESTS<br />
Report on Eligibility to Centralised Procedure for<br />
February 2017: For adoption<br />
A.2. Appointment of Rapporteur / Co-Rapporteur Full Applications<br />
Final Outcome of Rapporteurship allocation for<br />
February 2017: For adoption<br />
A.3. PRE-SUBMISSION ISSUES FOR INFORMATION<br />
Disclosure of information related to pre-submission of initial applications cannot be released at<br />
present time as these contain commercially confidential information.<br />
B. POST-AUTHORISATION PROCEDURES OUTCOMES<br />
B.1. Annual re-assessment outcomes<br />
B.1.1. Annual reassessment for products authorised under exceptional circumstances<br />
Glybera - alipogene tiparvovec -<br />
EMEA/H/C/002145/S/0057, Orphan,<br />
ATMP<br />
MAH: uniQure biopharma B.V., Rapporteur:<br />
Christiane Niederlaender, PRAC Rapporteur:<br />
Julie Williams<br />
Request for Supplementary Information adopted<br />
on 20.01.2017.<br />
Increlex - mecasermin -<br />
EMEA/H/C/000704/S/0041, Orphan<br />
MAH: Ipsen Pharma, Rapporteur: Outi Mäki-<br />
Ikola, PRAC Rapporteur: Kirsti Villikka<br />
Lojuxta - lomitapide -<br />
EMEA/H/C/002578/S/0023<br />
MAH: Aegerion Pharmaceuticals Limited,<br />
Rapporteur: Johann Lodewijk Hillege, PRAC<br />
Rapporteur: Menno van der Elst<br />
Request for Supplementary Information adopted<br />
on 10.11.2016.<br />
Obizur - susoctocog alfa -<br />
EMEA/H/C/002792/S/0006<br />
Annex to February 2017 CHMP Agenda<br />
EMA/CHMP/117606/2017 Page 3/66
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