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6.3. PSUR procedures including nationally authorised products (NAPs)<br />
only<br />
6.3.1. Acetylcysteine (NAP) - PSUSA/00000034/201509<br />
Applicant: various<br />
PRAC Lead: Adam Przybylkowski<br />
Scope: Evaluation of a PSUSA procedure<br />
Action: For adoption of recommendation to CMDh<br />
6.3.2. Alfentanil (NAP) - PSUSA/00000082/201509<br />
Applicant: various<br />
PRAC Lead: Almath Spooner<br />
Scope: Evaluation of a PSUSA procedure<br />
Action: For adoption of recommendation to CMDh<br />
6.3.3. Beractant (NAP) - PSUSA/00000384/201510<br />
Applicant: various<br />
PRAC Lead: Julie Williams<br />
Scope: Evaluation of a PSUSA procedure<br />
Action: For adoption of recommendation to CMDh<br />
6.3.4. Bisoprolol (NAP) - PSUSA/00000419/201509<br />
Applicant: various<br />
PRAC Lead: Kimmo Jaakkola<br />
Scope: Evaluation of a PSUSA procedure<br />
Action: For adoption of recommendation to CMDh<br />
6.3.5. Carmustine (implant) (NAP) - PSUSA/00010348/201509<br />
Applicant: various<br />
PRAC Lead: Isabelle Robine<br />
Scope: Evaluation of a PSUSA procedure<br />
Action: For adoption of recommendation to CMDh<br />
6.3.6. Chlorquinaldol (vaginal tablet), promestriene (NAP) - PSUSA/00009272/201509<br />
Applicant: various<br />
PRAC Lead: Roxana Stefania Stroe<br />
Scope: Evaluation of a PSUSA procedure<br />
Action: For adoption of recommendation to CMDh<br />
Pharmacovigilance Risk Assessment Committee (PRAC)<br />
EMA/PRAC/325452/2016 Page 34/52
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