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3.3.8. - buprenorphine / naloxone - EMEA/H/C/004407<br />
treatment for opioid drug dependence<br />
Scope: Day 120 list of questions<br />
Action: For adoption<br />
3.4. Update on on-going initial applications for Centralised procedure<br />
3.4.1. - prasterone - EMEA/H/C/004138<br />
treatment of vulvovaginal atrophy<br />
Scope: Letter from the applicant dated 14 February 2017 requesting an extension of clock<br />
stop to respond to the List of Outstanding Issues adopted on 26 January 2017<br />
Action: For adoption<br />
List of Outstanding Issues adopted on 26.01.2017, 13.10.2016. List of Questions adopted<br />
on 26.05.2016.<br />
3.4.2. - velmanase alfa - Orphan - EMEA/H/C/003922<br />
Chiesi Farmaceutici S.p.A.; for long-term enzyme replacement therapy in patients with<br />
alpha-mannosidosis<br />
Scope: Letter from the applicant dated 8 February 2017 requesting an extension of clock<br />
stop to respond to the List of Questions adopted on 26 January 2017<br />
Action: For adoption<br />
List of Questions adopted on 26.01.2017<br />
3.4.3. - miglustat - EMEA/H/C/004366<br />
treatment of Gaucher disease<br />
Scope: Letter from the applicant dated 8 February 2017 requesting an extension of clock<br />
stop to respond to the List of Questions adopted on 15 December 2016.<br />
Action: For adoption<br />
List of Questions adopted on 15.12.2016.<br />
3.4.4. - tigecycline - EMEA/H/C/004419<br />
treatment of: - complicated skin and soft tissue infections, excluding diabetic foot infections<br />
Scope: Letter from the applicant dated 7 February 2017 requesting an extension of clock<br />
stop to respond to the List of Questions adopted on 13 October 2016<br />
Action: For adoption<br />
Committee for medicinal products for human use (CHMP)<br />
EMA/CHMP/117089/2017 Page 16/39
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