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15.1.16. Irbesartan, hydrochlorothiazide – COAPROVEL (CAP), KARVEZIDE (CAP),<br />
IRBESARTAN HYDROCHLOROTHIAZIDE ZENTIVA (CAP), NAP<br />
<br />
Evaluation of a PSUSA 38 procedure<br />
Regulatory details:<br />
PRAC Rapporteur: Dolores Montero Corominas (ES)<br />
Administrative details:<br />
Procedure number(s): EMEA/H/C/PSUSA/00001653/201309<br />
MAH(s): Sanofi Clir SNC (CoAprovel), Sanofi-Aventis Groupe (Karvizide, Irbesartan hydrochlorothiazide<br />
Zentiva), various<br />
15.1.17. Linaclotide – CONSTELLA (CAP)<br />
<br />
Evaluation of a PSUR procedure<br />
Regulatory details:<br />
PRAC Rapporteur: Valerie Strassmann (DE)<br />
Administrative details:<br />
Procedure number(s): EMEA/H/C/002490/PSUV/0010<br />
MAH(s): Almirall S.A.<br />
15.1.18. Pandemic influenza vaccine (H1N1) (whole virion, inactivated, prepared in cell<br />
culture) – CELVAPAN (CAP)<br />
<br />
Evaluation of a PSUR procedure<br />
Regulatory details:<br />
PRAC Rapporteur: Brigitte Keller-Stanislawski (DE)<br />
Administrative details:<br />
Procedure number(s): EMEA/H/C/000982/PSUV/0027<br />
MAH(s): Baxter AG<br />
15.1.19. Pegvisomant – SOMAVERT (CAP)<br />
<br />
Evaluation of a PSUR procedure<br />
Regulatory details:<br />
PRAC Rapporteur: Isabelle Robine (FR)<br />
Administrative details:<br />
Procedure number(s): EMEA/H/C/000409/PSUV/0070<br />
MAH(s): Pfizer Limited<br />
15.1.20. Piperaquine, dihydroartemisinin – EURARTESIM (CAP)<br />
<br />
Evaluation of a PSUR procedure<br />
Regulatory details:<br />
PRAC Rapporteur: Julie Williams (UK)<br />
Administrative details:<br />
Procedure number(s): EMEA/H/C/001199/PSUV/0011<br />
MAH(s): Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.<br />
38 PSUR single assessment, referring to CAP, NAP<br />
Pharmacovigilance Risk Assessment Committee (PRAC)<br />
EMA/PRAC/438418/2014 Page 63/75
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