Commission. Product. Notification. Decision. Issued 2 / affected 3 amended on

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1 Procedural steps taken and scientific information after the authorisation Application Scope Opinion/ Commission Product Summary number Notification Decision Information 1 issued on Issued 2 / affected 3 amended on R/0032 Renewal of the marketing authorisation. 22/02/ /04/2018 Based on the review of data on quality, safety and efficacy, the CHMP considered that the benefit-risk balance of in the approved indication remains favourable and therefore recommended the renewal of the marketing authorisation with unlimited validity. / /02/2018 n/a PRAC Recommendation - maintenance 1 Notifications are issued for type I variations and Article 61(3) notifications (unless part of a group including a type II variation or extension application or a worksharing application). Opinions are issued for all other procedures. 2 A Commission decision (CD) is issued for procedures that affect the terms of the marketing authorisation (e.g. summary of product characteristics, annex II, labelling, package leaflet). The CD is issued within two months of the opinion for variations falling under the scope of Article 23.1a(a) of Regulation (EU) No. 712/2012, or within one year for other procedures. 3 SmPC (Summary of Product Characteristics), Annex II, Labelling, PL (Package Leaflet). 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0) Facsimile +44 (0) Send a question via our website An agency of the European Union

2 IB/0033 B.II.f.1.b.5 - Stability of FP - Extension of the shelf life of the finished product - Biological/immunological medicinal product in accordance with an approved stability protocol 30/01/ /04/2018 SmPC S/0029 Annual re-assessment. 09/11/2017 n/a The CHMP, having reviewed the evidence of compliance with the specific obligations and the impact of the data submitted by the MAH on the benefit/risk profile of the medicinal product, concluded that marketing authorisation of should be maintained IB/0030 C.I.11.z - Introduction of, or change(s) to, the 06/11/2017 n/a obligations and conditions of a marketing authorisation, including the RMP - Other variation II/0027 B.I.b.2.d - Change in test procedure for AS or 14/09/ /11/2017 SmPC, SmPC Section 2 and 4.8 has been updated as follows: starting material/reagent/intermediate - Substantial Labelling and One dose (0.5 ml) contains: change to or replacement of a PL Modified Vaccinia Ankara Bavarian Nordic Live virus1 no biological/immunological/immunochemical test less than 5 x 107 Inf.U * method or a method using a biological reagent for a *infectious units biological AS / /09/2017 n/a PRAC Recommendation - maintenance IB/0026 C.I.11.z - Introduction of, or change(s) to, the obligations and conditions of a marketing authorisation, including the RMP - Other variation 11/04/ /11/2017 Annex II / /02/2017 n/a PRAC Recommendation - maintenance EMA/300806/2018 Page 2/9

3 S/0022 Annual re-assessment. 10/11/ /02/2017 Annex II The CHMP, having reviewed the evidence of compliance with the specific obligations and the impact of the data submitted by the MAH on the benefit/risk profile of the medicinal product, concluded that Marketing Authorisation of should be maintained. The SOB1 in Annex II of the Product Information is deleted, as the MAH has provided adequate information to reassure that assays used to measure antibody titres over time are adequately validated. IB/0025/G This was an application for a group of variations. 11/01/2017 n/a B.I.b.2.a - Change in test procedure for AS or starting material/reagent/intermediate - Minor changes to an approved test procedure IB/0024 B.II.f.1.b.5 - Stability of FP - Extension of the shelf life of the finished product - Biological/immunological medicinal product in accordance with an approved stability protocol 23/11/ /11/2017 SmPC / /09/2016 n/a PRAC Recommendation - maintenance II/0018 C.I.4 - Change(s) in the SPC, Labelling or PL due to new quality, preclinical, clinical or pharmacovigilance data 26/05/ /08/2016 SmPC and PL EMA/300806/2018 Page 3/9

4 II/0020 Update of sections 4.8 and 5.1 of the SmPC based on 21/04/ /08/2016 SmPC, Annex In the clinical study MVA-POX-013, three consecutive data from Study MVA-POX-013, a randomised, II and PL production lots of (MVA-BN) are compared. The double-blind, placebo-controlled phase III trial to data suggest comparable performance between lots. The evaluate immunogenicity and safety of three combined groups 1-3 included 2119 healthy subjects and consecutive production lots of Imvanex (MVA-BN) the PRNT and ELISA seroconversion rates for the pooled smallpox vaccine in healthy vaccinia-naive subjects. vaccine lots were 99.8% (95% CI: 99.5; 99.9) and 99.7% The Package Leaflet has been updated accordingly. (95% CI: 99.4; 99.9), respectively. Further, the MAH has The provision of the study report addresses the post- submitted an analysis of the safety data from the 3,000 authorisation measure (PAM) ANX 003, which has subjects who were exposed across the three vaccine lots been deleted accordingly in Annex II. which were tested. The rates of adverse events were generally consistent across the lots. No new safety C.I.4 - Change(s) in the SPC, Labelling or PL due to concerns are raised based on the information provided. new quality, preclinical, clinical or pharmacovigilance data / /02/2016 n/a PRAC Recommendation - maintenance S/0017 Annual re-assessment. 28/01/2016 n/a / /09/2015 n/a PRAC Recommendation - maintenance IB/0016 B.II.f.1.d - Stability of FP - Change in storage conditions of the finished product or the diluted/reconstituted product 03/08/ /09/2015 SmPC, Annex II and PL IB/0015 B.I.a.1.z - Change in the manufacturer of AS or of a starting material/reagent/intermediate for AS - Other variation 22/06/2015 n/a EMA/300806/2018 Page 4/9

5 II/0013/G This was an application for a group of variations. 26/03/2015 n/a Submission of non-clinical final study reports for studies BN-PRE (Study for effects on embryo-fetal development by subcutaneous route in rats), BN-PRE (Determination of the optimal dose of monkeypox for the aerosol challenge model in cynomolgus macaques and evaluation of efficacy and immunogenicity of IMVAMUNE), BN-PRE (Correlation of neutralising antibody titers with survival of cynomolgus monkeys in the aerosol monkeypox virus challenge model), BN-PRE (Non-inferiority of the immunogenicity of freezedried IMVAMUNE compared to liquid-frozen IMVAMUNE in a BALB/c mouse model), BN-PRE (Non-inferiority of efficacy and immunogenicity of freeze-dried IMVAMUNE compared to liquid-frozen IMVAMUNE in the mouse vaccinia challenge model), BN-PRE (Non-inferiority of efficacy and immunogenicity of freeze-dried IMVAMUNE compared to liquid-frozen IMVAMUNE in a mouse ectromelia challenge model). EMA/300806/2018 Page 5/9

6 / /02/2015 n/a PRAC Recommendation - maintenance IB/0012 B.II.f.1.d - Stability of FP - Change in storage conditions of the finished product or the diluted/reconstituted product 15/12/ /09/2015 SmPC, Labelling and PL S/0010 1st Annual Re-assessment. 20/11/2014 n/a The CHMP, having reviewed the evidence on compliance with the specific obligations and the impact of the data submitted by the MAH on the benefit/risk profile of Imvanex, concluded that Marketing Authorisation of Imvanex should be maintained. II/0008/G This was an application for a group of variations. 25/09/ /09/2015 SmPC, to introduce an alternative storage temperature of the Labelling and finished product at -80 C. The shelf-life of the finished to introduce an alternative storage temperature of PL product stored at -80 C is 5 years. the finished product at -80 C. The shelf-life of the finished product stored at -80 C is 5 years. B.II.f.1.b.5 - Stability of FP - Extension of the shelf life of the finished product - Biological/immunological medicinal product in accordance with an approved EMA/300806/2018 Page 6/9

7 stability protocol B.II.f.1.c - Stability of FP - Change in storage conditions for biological medicinal products, when the stability studies have not been performed in accordance with an approved stability protocol IB/0009 B.II.b.3.z - Change in the manufacturing process of the finished or intermediate product - Other variation 03/09/2014 n/a PSUV/0007 Periodic Safety Update 26/06/ /08/2014 SmPC and PL Please refer to PSUV-07 EPAR: Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation. II/0004/G This was an application for a group of variations. Update of Section 4.8 of the SmPC to reflect pooled safety data from completed clinical trials. The PL is updated accordingly. C.I.4 - Change(s) in the SPC, Labelling or PL due to new quality, preclinical, clinical or pharmacovigilance data C.I.4 - Change(s) in the SPC, Labelling or PL due to new quality, preclinical, clinical or pharmacovigilance data 26/06/ /08/2014 SmPC and PL Based on the results of a completed Clinical Study POX MVA 030 and a pooling of ADRs from all Imvanex studies, the MAH proposed changes to the Product Information (PI). Information was updated to amend the number of studies making up the source of the pooled Safety information and the number of patients constituting the dataset in the SmPC. The frequency of a number of adverse events was re-assigned based on the new figures. Chest pain was added to the list of Side Effects observed with Imvanex. IB/0006 B.I.a.3.e - Change in batch size (including batch size ranges) of AS or intermediate - The scale for a biological/immunological AS is increased/decreased without process change (e.g. duplication of line) 04/03/2014 n/a IB/0005/G This was an application for a group of variations. 23/01/2014 n/a EMA/300806/2018 Page 7/9

8 B.I.a.2.a - Changes in the manufacturing process of the AS - Minor change in the manufacturing process of the AS B.I.b.2.a - Change in test procedure for AS or starting material/reagent/intermediate - Minor changes to an approved test procedure EMA/300806/2018 Page 8/9

9 IB/ /12/2013 n/a IAIN/0002 C.I.8.a - Introduction of or changes to a summary of Pharmacovigilance system - Changes in QPPV (including contact details) and/or changes in the PSMF location 09/12/2013 n/a IAIN/0001 C.I.9.a - Changes to an existing pharmacovigilance system as described in the DDPS - Change in the QPPV and/or QPPV contact details and/or back-up procedure 06/09/2013 n/a EMA/300806/2018 Page 9/9