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are in accordance with the WHO recommendation and the EU decision for the 2014/2015 season. The PRAC is responsible for providing advice to the CHMP on the necessary updates to the RMP to support this variation. Summary of advice The updated RMP for Optaflu (surface antigen, inactivated, prepared in cell cultures) in the context of the variation under evaluation by the CHMP was not yet considered acceptable. Supplementary information relating to the proposal of enhanced surveillance activities to provide data each year, feasibility, sample size and indicators used to assess whether the proposed surveillance has achieved its objective should be submitted before finalisation of the variation procedure by the CHMP. 5.2.5. Nitric oxide – INOMAX (CAP) Evaluation of an RMP in the context of a variation Regulatory details: PRAC Rapporteur: Julie Williams (UK) Administrative details: Procedure number(s): EMEA/H/C/000337/II/0039 Procedure scope: Update of SmPC section 4.8 and Annex IID and RMP with respect to details of training and education methods to be used for INOmax and the approved nitric oxide delivery systems (NODS) MAH(s): Linde Healthcare AB Background Inomax is a centrally authorised product containing nitric oxide used in conjunction with ventilatory support and other appropriate active substances, for the treatment of newborn infants ≥34 weeks gestation with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, in order to improve oxygenation and to reduce the need for extracorporeal membrane oxygenation. Inomax is also indicated as part of the treatment of peri- and post-operative pulmonary hypertension in adults and newborn infants, infants and toddlers, children and adolescents, ages 0-17 years in conjunction to heart surgery, in order to selectively decrease pulmonary arterial pressure and improve right ventricular function and oxygenation. The CHMP is evaluating a type II variation procedure for Inomax to update regarding the details of training and education methods to be used for Inomax and the approved nitric oxide delivery systems (NODS). The PRAC is responsible for providing advice to the CHMP on the necessary updates to the RMP to support this variation. Summary of advice The RMP version 2 for Inomax (nitric oxide) in the context of the variation under evaluation by the CHMP was not yet considered acceptable and supplementary information relating to the use and effectiveness of the existing pocket guide and any proposals for alternative educational materials was required before finalisation of the variation procedure by the CHMP; moreover off- label use, device issues and accidental exposure to the product by HCPs should be added as potential risks. 5.2.6. Ofatumumab – ARZERRA (CAP) Evaluation of an RMP in the context of a variation Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/438418/2014 Page 28/75
Regulatory details: PRAC Rapporteur: Doris Stenver (DK) Administrative details: Procedure number(s): EMEA/H/C/001131/II/0027 Procedure scope: Update of SmPC sections 4.4 and 4.8 with regard to infusion reactions MAH(s): Glaxo Group Ltd Background Arzerra is a centrally authorised product containing ofatumumab, a monoclonal antibody used in the treatment of chronic lymphocytic leukaemia (CLL) in patients who are refractory to fludarabine and alemtuzumab. The CHMP is evaluating a type II variation procedure for Arzerra, to include information with regard to infusion reactions in the product information. The PRAC is responsible for providing advice to the CHMP on the necessary updates to the RMP to support this variation. Summary of advice The RMP version 7 for Arzerra (ofatumumab) in the context of the variation under evaluation by the CHMP was considered acceptable. Minor amendments were recommended for the next update of the RMP as well as some refinements of the proposed text for the product information. The PRAC also agreed on a DHPC and communication plan. RMP evaluated in the context of a PSUR procedure See also Deferasirox – EXJADE under 6.1.4. , Eribulin – HALAVEN under 15.1.9. , Erlotinib – TARCEVA under 15.1.10. , Pixantrone dimaleate – PIXUVRI under 6.1.8. , Rotavirus vaccine, live, oral – ROTATEQ under 15.1.24. , Sapropterin – KUVAN under 15.1.25. , Tafamidis – VYNDAQEL under 15.1.28. RMP evaluated in the context of PASS results See also Ceftaroline fosamil – ZINFORO under 16.4.1. , Eltrombopag – REVOLADE under 16.4.2. RMP evaluated in the context of a renewal of the marketing authorisation, conditional renewal or annual reassessment See Annex 14.2 RMP evaluated in the context of a stand-alone RMP procedure See Annex 14.2 6. Periodic Safety Update Reports (PSURs) 6.1. Evaluation of PSUR procedures 19 6.1.1. Aflibercept – EYLEA (CAP) Evaluation of a PSUR procedure 19 Where a regulatory action is recommended (variation, suspension or revocation of the terms of Marketing Authorisation(s)), the assessment report and PRAC recommendation are transmitted to the CHMP for adoption of an opinion. Where PRAC recommends the maintenance of the terms of the marketing authorisation(s), the procedure finishes at the PRAC level. Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/438418/2014 Page 29/75
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