WC500165698

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3.2. Ongoing Procedures 3.2.1. Agents acting on the renin-angiotensin system (CAP, NAP): angiotensin receptor blockers (ARBs), angiotensin converting enzyme inhibitors (ACEi), direct renin inhibitors (aliskiren) Review of the risks of dual blockade of the renin angiotensin system through concomitant use of ARBs, ACEi or aliskiren-containing medicines following the notification by Italy of a referral under Article 31 of Directive 2001/83/EC based on pharmacovigilance data Regulatory details: PRAC Rapporteur: Carmela Macchiarulo (IT) PRAC Co-Rapporteurs: Margarida Guimarães (PT), Valerie Strassmann (DE), Tatiana Magálová (SK), Dolores Montero Corominas (ES), Almath Spooner (IE), Menno van der Elst (NL), Julie Williams (UK), Qun-Ying Yue (SE) Administrative details: Procedure number: EMEA/H/A-31/1370 EPITT 13359 – Follow up January 2014 PRAC Co-Rapporteurs (responsibility per substance): Margarida Guimarães (PT) (lisinopril); Carmela Macchiarulo (IT) (delapril, telmisartan, aliskiren, moexipril); Tatiana Magálová (SK) (spirapril, quinapril); Dolores Montero Corominas (ES) (fosinopril, irbesartan); Almath Spooner (IE) (benazepril, cilazapril, perindopril); Valerie Strassmann (DE) (ramipril, eprosartan, olmesartan); Menno van der Elst (NL) (trandolapril, losartan, azilsartan); Julie Williams (UK) (captopril, imidapril, zofenopril, candesartan); Qun-Ying Yue (SE) (enalapril, valsartan) MAH(s): Actavis (Telmisartan Actavis, Actelsar HCT), Bayer Smith Kline Beecham (Kinzalmono, Kinzalkomb, Pritor, Pritor Plus), Boehringer Ingelheim (Micardis, Micardis Plus, Onduarp, Twynsta), Krka (Ifirmasta, Ifirmacombi, Tolura), Novartis (Copalia, Copalia HCT, Exforge, Exforge HCT, Dafiro, Dafiro HCT, Imprida), Novartis Europharm Ltd (Rasilamlo, Rasilez, Rasilez HCT, Rasitrio), Pharmathen S.A. (Sabervel), Sanofi-Winthrop / BMS (Aprovel, CoAprovel, Irbesartan Zentiva, Irbesartan HCT Zentiva, Karvea, Karvezide), Takeda (Edarbi, Ipreziv), Teva Pharma / Pharmachemie (Irbesartan Teva, Irbesartan HCT Teva, Telmisartan Teva, Telmisartan Teva Pharma), various Background A referral procedure under Article 31 is ongoing to review the benefit-risk of the concomitant use (dual blockade of the renin-angiotensin system) of ARBs, ACE-inhibitors or aliskiren-containing medicines (see PRAC minutes 6-10 January 2014). The Co-Rapporteurs prepared an assessment based on the data received by the MAHs for discussion at PRAC and IT as PRAC Rapporteur presented an overall assessment report. Summary of recommendation(s)/conclusions The PRAC discussed some aspects to be further elucidated during the course of the review and heard feed-back from the Scientific Advisory Group meeting held on 11 of February 2014. The PRAC agreed on a second list of outstanding issues to be addressed by the MAHs and adopted a revised timetable for the procedure (EMA/PRAC/290691/2013 rev3). Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/253432/2014 Page 10/64
3.2.2. Bromocriptine (NAP) Review of the benefit-risk balance following notification by France of a referral under Article 31 of Directive 2001/83/EC, based on pharmacovigilance data Regulatory details: PRAC Rapporteur: Sabine Straus (NL) PRAC Co-Rapporteur: Isabelle Robine (FR) Administrative details: Procedure number: EMEA/H/A-31/1379 MAH(s): Sanofi-aventis, Meda Pharma, various Background A referral procedure under Article 31 of Directive 2001/83/EC is ongoing for bromocriptine-containing medicines in the inhibition of lactation (see PRAC minutes 2-5 September 2013). The (Co-)Rapporteurs assessed the data submitted by some of the MAHs on the issue. Summary of recommendation(s)/conclusions The PRAC noted further aspects to be addressed during the review and agreed on a list of outstanding issues and on an updated timetable (EMA/PRAC/493206/2013 rev.1). 3.3. Procedures for finalisation 3.3.1. Domperidone (NAP) Review of the benefit-risk balance following notification by Belgium of a referral under Article 31 of Directive 2001/83/EC based on pharmacovigilance data Regulatory details: PRAC Rapporteur: Isabelle Robine (FR) PRAC Co-Rapporteur: Jean-Michel Dogné (BE) Administrative details: Procedure number: EMEA/H/A-31/1365 EPITT 15994 – Follow up January 2014 MAH(s): Janssen-Cilag, various Oral Explanation(s): Janssen-Cilag Background A referral procedure under Article 31 of Directive 2001/83/EC for domperidone-containing medicines (see minutes of the PRAC 6-9 January 2014) was to be concluded. A final assessment of the data submitted was produced by the Rapporteurs according to the agreed timetable. Discussion The PRAC discussed the conclusion reached by the Rapporteurs. One oral explanation took place at the meeting. The review confirmed a small increased risk of serious cardiac adverse drug reactions related to the use of domperidone. A higher risk was observed in patients older than 60 years, patients taking daily doses of more than 30 mg, and those taking QT-prolonging drugs or CYP3A4 inhibitors concomitantly. Therefore the PRAC agreed on a series of risk minimisation measures including a restriction of the indication to the relief of the symptoms of nausea and vomiting in which benefit risk Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/253432/2014 Page 11/64
Page 1 and 2: 10 April 2014 EMA/PRAC/253432/2014
Page 3 and 4: Table of contents Note on access to
Page 5 and 6: 10.2. Timing and message content in
Page 7 and 8: 15.1.8. Dronedarone - MULTAQ (CAP)
Page 9: 1. Introduction 1.1. Welcome and de
Page 13 and 14: Discussion The PRAC discussed the e
Page 15 and 16: Background Cefepime is a cephalospo
Page 17 and 18: Summary of recommendation(s) The M
Page 19 and 20: conducted in the US Veterans Affair
Page 21 and 22: Taken together, the available evide
Page 23 and 24: eported in 38.5% of the cases. Amon
Page 25 and 26: 5.2. Medicines already authorised R
Page 27 and 28: Summary of advice The RMP version
Page 29 and 30: Background Colistimethate sodium is
Page 31 and 32: The next PSUR should be submitted i
Page 33 and 34: Administrative details: Procedure n
Page 35 and 36: Summary of advice Based on the revi
Page 37 and 38: 10.3. Other requests None 11. Other
Page 39 and 40: The PRAC endorsed the final version
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Page 45 and 46: 14.1.13. Tobramycin Evaluation of
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Page 49 and 50: Procedure scope: Grouping of three
Page 57 and 58: 16.2. Protocols of PASS non-imposed
Page 59 and 60: Procedure scope: Evaluation of fina
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Administrative details: Procedure n
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PRAC members and alternates Country
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