Committee for medicinal products for human use (CHMP)
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2eO29eq
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3.2.5. - pentosan polysulfate sodium - Orphan - EMEA/H/C/004246<br />
bene-Arzneimittel GmbH; treatment of Interstitial Cystitis<br />
Scope: Day 180 list of outstanding issue<br />
Action: For adoption<br />
List of Questions adopted on 23.06.2016.<br />
3.2.6. - rolapitant - EMEA/H/C/004196<br />
prevention of na<strong>use</strong>a and vomiting<br />
Scope: Day 180 list of outstanding issue<br />
Action: For adoption<br />
List of Questions adopted on 21.07.2016.<br />
3.3. Initial applications; List of questions (Day 120; Day 90 <strong>for</strong> procedures<br />
with accelerated assessment timetable)<br />
3.3.1. - cladribine - EMEA/H/C/004230<br />
treatment of highly active relapsing-remitting multiple sclerosis (MS)<br />
Scope: Day 120 list of questions<br />
Action: For adoption<br />
3.3.2. - efavirenz / emtricitabine / tenofovir disoproxil - EMEA/H/C/004250<br />
treatment of HIV-1 infection<br />
Scope: Day 120 list of questions<br />
Action: For adoption<br />
3.3.3. - sarilumab - EMEA/H/C/004254<br />
treatment of active rheumatoid arthritis<br />
Scope: Day 120 list of questions<br />
Action: For adoption<br />
BWP report<br />
3.3.4. - etirinotecan pegol - EMEA/H/C/003874<br />
Accelerated assessment<br />
treatment of breast cancer with brain metastases<br />
Scope: Day 120 list of questions<br />
Action: For adoption<br />
<strong>Committee</strong> <strong>for</strong> <strong>medicinal</strong> <strong>products</strong> <strong>for</strong> <strong>human</strong> <strong>use</strong> (<strong>CHMP</strong>)<br />
EMA/<strong>CHMP</strong>/682760/2016 Page 12/30
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