TRANSPARENCY COMMITTEE OPINION. 21 January 2009

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1 The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION 21 January 2009 BRIDION 100 mg/ml, solution for injection Box containing 10 x 2 ml bottles, CIP: Box containing 10 x 5 ml bottles, CIP: Applicant: ORGANON SA Sugammadex sodium ATC Code: V03AB35 List 1 Medicinal product for hospital use only. Medicinal product that can be administered by any doctor specialised in anaesthesia and intensive care or in emergency medicine when involved in an emergency situation or in a mobile medical unit or repatriation unit (Art. R of the public health code). Date of Marketing Authorisation: 25 July 2008 (centralised marketing authorisation procedure) Reason for request: Inclusion on the list of medicines approved for use by hospitals. Medical, Economic and Public Health Assessment Division 1

2 1 PROPERTIES OF THE MEDICINAL PRODUCT 1.1. Active ingredient Sugammadex sodium 1.2. Background BRIDION is the first of the γ-cyclodextrins to be indicated for reversal of neuromuscular blockade Indication "Reversal of neuromuscular blockade induced by rocuronium or vecuronium. For the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents. " Dosage "Sugammadex should only be administered by, or under the supervision of an anaesthetist. The use of an appropriate neuromuscular monitoring technique is recommended to monitor the recovery of neuromuscular blockade. As is normal post-anaesthetic practice following neuromuscular blockade it is recommended to monitor the patient in the immediate postoperative period for untoward events including re-occurrence of blockade. When certain medicinal products that may cause displacement interactions are administered parenterally within a period of 6 hours of sugammadex, the patient should be monitored for signs of reoccurrence of blockade. The recommended dose of sugammadex depends on the level of neuromuscular blockade to be reversed. The recommended dose does not depend on the anaesthetic regimen. Sugammadex can be used to reverse different levels of rocuronium or vecuronium induced neuromuscular blockade: Adults: Routine reversal: A dose of 4 mg/kg sugammadex is recommended if recovery has reached at least 1-2 post-tetanic counts (PTC) following rocuronium or vecuronium induced blockade. Median time to recovery of the T4/T1 ratio to 0.9 is around 3 minutes. A dose of 2 mg/kg sugammadex is recommended, if spontaneous recovery has occurred up to at least the reappearance of T2 following rocuronium or vecuronium induced blockade. Median time to recovery of the T4/T1 ratio to 0.9 is around 2 minutes. Using the recommended doses for routine reversal will result in a slightly faster median time to recovery of the T4/T1 ratio to 0.9 of rocuronium when compared to vecuronium induced neuromuscular blockade. Immediate reversal of rocuronium-induced blockade: If there is a clinical need for immediate reversal following administration of rocuronium a dose of 16 mg/kg sugammadex is recommended. When 16 mg/kg sugammadex is administered 3 minutes after a bolus dose of 1.2 mg/kg rocuronium bromide, a median time to recovery of the T4/T1 ratio to 0.9 of approximately 1.5 minutes can be expected. There is no data to recommend the use of sugammadex for immediate reversal following vecuronium induced blockade. Re-administration of sugammadex: In the exceptional situation of re-occurrence of blockade post-operatively (see section 4.4) after an initial dose of 2 mg/kg or 4 mg/kg sugammadex, a repeat dose of 4 mg/kg sugammadex is recommended. Following a second dose of sugammadex, the patient should be closely monitored to ascertain sustained return of neuromuscular function. 2

3 Re-administration of rocuronium or vecuronium after sugammadex: A waiting time of 24 hours should be taken into account. Additional information on special populations Renal impairment: For mild and moderate renal impairment (creatinine clearance 30 and < 80 ml/min): the dose recommendations are the same as for adults. The use of sugammadex in patients with severe renal impairment (including patients requiring dialysis (CrCl < 30 ml/min)) is not recommended. Elderly patients: After administration of sugammadex at reappearance of T2 following a rocuronium induced blockade, the median time to recovery of the T4/T1 ratio to 0.9 in adults (18-64 years) was 2.2 minutes, in elderly adults (65-74 years) it was 2.6 minutes and in very elderly adults (75 years or more) it was 3.6 minutes. Even though the recovery times in elderly tend to be slower, the same dose recommendation as for adults should be followed. Obese patients: In obese patients, the dose of sugammadex should be based on actual body weight. The same dose recommendations as for adults should be followed. Hepatic impairment: For mild to moderate hepatic impairment: as sugammadex is mainly excreted renally no dose adjustments are required. Studies in patients with hepatic impairment have not been conducted and therefore patients with severe hepatic impairment should be treated with great caution. Paediatric population: The data for the paediatric population are limited (one study only for reversal of rocuronium induced blockade at reappearance of T2): Children and adolescents: For routine reversal of rocuronium induced blockade at reappearance of T2 in children and adolescents (2-17 years) 2 mg/kg sugammadex is recommended. Other routine reversal situations have not been investigated and are therefore not recommended until further data become available. Immediate reversal in children and adolescents has not been investigated and is therefore not recommended until further data become available. Bridion 100 mg/ml may be diluted to 10 mg/ml to increase the accuracy of dosing in the paediatric population. Term newborn infants and infants: There is only limited experience with the use of sugammadex in infants (30 days to 2 years), and term newborn infants (less than 30 days) have not been studied. The use of sugammadex in term newborn infants and infants is therefore not recommended until further data become available. Method of administration Sugammadex should be administered intravenously as a single bolus injection. The bolus injection should be given rapidly, within 10 seconds directly into a vein or into an existing intravenous line. Sugammadex has only been administered as a single bolus injection in clinical trials. " 2 COMPARABLE MEDICINAL PRODUCTS 2.1. ATC Classification V: Other V03: All other therapeutic products V03A: All other therapeutic products V03AB: Antidotes V03AB35: Sugammadex 3

4 2.2. Medicines in the same therapeutic category There are no other γ-cyclodextrins indicated for "reversal of rocuronium or vecuroniuminduced neuromuscular blockade" Medicines with a similar therapeutic aim PROSTIGMINE (neostigmine), a cholinesterase inhibitor indicated for "post-operative reversal of blockade (following induction of blockade by non-depolarising agents)". 3 ANALYSIS OF AVAILABLE DATA 3.1. Efficacy The efficacy and safety of BRIDION have been assessed using four phase III studies involving a total of 529 patients (288 receiving BRIDION) in three reversal situations: - Routine reversal of moderate neuromuscular blockade: Studies and , the aim of which was to compare the efficacy of a bolus injection of BRIDION (2 mg/kg) with that of neostigmine (50 µg/kg) in terms of time to recovery of T4/T1 1 ratio of more than 0.9 in patients with rocuronium- or vecuronium-induced neuromuscular blockade. - Routine reversal of profound neuromuscular blockade: Study , the aim of which was to compare the efficacy of a bolus injection of BRIDION (4 mg/kg) with that of neostigmine (70 µg/kg) in terms of time to recovery of T4/T1 ratio of more than 0.9 in patients with rocuronium- or vecuronium-induced neuromuscular blockade. - Immediate reversal: Study , the aim of which was to compare the efficacy of BRIDION (16 mg/kg) injected 3 minutes after administration of rocuronium versus spontaneous recovery after administration of succinylcholine (1 mg/kg) in terms of median time to recovery of T1 to 10%. The dossier also includes study , carried out in a partially paediatric population (10 children and 6 adults). The dossier also includes four studies carried out on specific patient populations (those with renal impairment, the elderly, children, patients with pulmonary or cardiac complications) the aims of which were to evaluate the influence of these clinical conditions on the efficacy of BRIDION and to define the optimal dosages. The main conclusions from these studies are summarised in the SPC for BRIDION. These studies will not be further examined in this opinion Routine reversal of moderate neuromuscular blockade Study Methodology: Phase III open-label randomised parallel-group trial versus neostigmine, involving 189 patients under general anaesthetic with rocuronium- or vecuronium-induced neuromuscular blockade. 1 T4/T1 = intensity of fourth response with respect to first response expressed as a decimal (between 0 and 1.0) following a train-of-four stimulation. In non-depolarising neuromuscular blockade, the T4/T1 ratio shows the degree of blockade or reversal. 4

5 Inclusion criteria: Patients aged over 18 years with: - ASA I-IV, - under general anaesthetic requiring administration of rocuronium or vecuronium for tracheal intubation and maintenance of neuromuscular blockade, - planned surgical procedure in decubitus position. Treatment: Group pre-treated with rocuronium - BRIDION, bolus of 2 mg/kg, n = 48, - Neostigmine, one injection of 50 µg/kg, n = 48. Group pre-treated with vecuronium - BRIDION, bolus of 2 mg/kg, n = 48, - Neostigmine, one injection of 50 µg/kg, n = 45. The treatments were administered after the last dose of rocuronium or vecuronium and reappearance of T2. Primary endpoint: time to recovery 2 of T4/T1 ratio greater than or equal to 0.9 following one injection. RESULTS: ITT analysis (see Table 1) On inclusion, patient characteristics were generally similar. Table 1: time to recovery of T4/T1 ratio greater than or equal to 0.9 following one injection. BRIDION 2 mg/kg Neostigmine 50 µg/kg p Rocuronium group Recovery time (min): - mean [95% CI] - median [min - max] Vecuronium group: Recovery time (min): - mean [95% CI] n= [ ] 1.4 [ ] n= [ ] 2.1 [ ] n= [ ] 17.6 [ ] n= [ ] 18.9 [ ] <0.001 < median [min - max] After one injection, improvement in the median time to recovery of T4/T1 ratio greater than or equal to 0.9 was observed in the BRIDION 2 mg/kg arm versus the neostigmine 50 µg/kg arm. - group pre-treated with rocuronium: 1.4 minutes versus 17.6, p< group pre-treated with vecuronium: 2.1 minutes versus 18.9, p< Study Methodology: Phase III open-label randomised parallel-group trial of rocuronium + BRIDION versus cisatracurium + neostigmine, involving 73 patients under general anaesthetic with neuromuscular blockade. Inclusion criteria: Patients aged over 18 years with: - ASA I-IV, - under general anaesthetic requiring administration of rocuronium or cisatracurium for induction and maintenance of neuromuscular blockade, - planned surgical procedure in decubitus position. 2 Recovery was evaluated by measuring the amplitude of contractions of the thumb adductor using an acceleromyograph (TOF-Watch SX portable acceleromyograph). Recovery is defined as complete when T4/T1 ratio is equal to 1, and lack of residual blockade is confirmed when the ratio is greater than or equal to

6 Treatment: - BRIDION, bolus of 2 mg/kg, n = 34, - Neostigmine, one injection of 50 µg/kg, n = 39. The treatments were administered after the last dose of rocuronium or cisatracurium and reappearance of T2. Primary endpoint: time to recovery of T4/T1 ratio greater than or equal to 0.9 following one injection. RESULTS: ITT analysis (see Table 2) On inclusion, patient characteristics were generally similar. Table 2: time to recovery of T4/T1 ratio greater than or equal to 0.9 following one injection. BRIDION 2 mg/kg after rocuronium Neostigmine 50 µg/kg after cisatracurium n=34 n=39 Recovery time (min): - mean [95% CI] 2.0 [ ] 8.8 [ ] - median [min - max] 1.9 [ ] 7.2 [ ] p <0.001 After one injection, improvement in the median time to recovery of T4/T1 ratio greater than or equal to 0.9 was observed in the BRIDION 2 mg/kg arm versus the neostigmine 50 µg/kg arm: 1.9 minutes versus 7.2 minutes, p< Note: as the blocking agents were different in each arm, interpretation of the results is difficult Routine reversal of profound neuromuscular blockade: Study Methodology: Phase III open-label randomised parallel-group trial versus neostigmine, involving 157 patients under general anaesthetic with rocuronium- or vecuronium-induced neuromuscular blockade. Inclusion criteria: Patients aged over 18 years with: - ASA I-IV, - under general anaesthetic requiring administration of rocuronium or vecuronium for tracheal intubation and maintenance of neuromuscular blockade, - planned surgical procedure in decubitus position. Treatment: Group pre-treated with rocuronium - BRIDION, bolus of 4 mg/kg, n = 37, - Neostigmine, one injection of 70 µg/kg, n = 37. Group pre-treated with vecuronium - BRIDION, bolus of 4 mg/kg, n = 47, - Neostigmine, one in jection of 70 µg/kg, n = 36. The treatments were administered after the last dose of rocuronium or vecuronium and reappearance of T2. NB: The choice of neostigmine as a comparator is a moot point, given that neostigmine is not indicated for reversal of profound neuromuscular blockade. In addition, the dosage of neostigmine used in this study is greater than the maximum dose permitted in its marketing authorisation (60 µg/kg). Primary endpoint: time to recovery of T4/T1 ratio greater than or equal to 0.9 following one injection. 6

7 RESULTS: ITT analysis (see Table 3) On inclusion, patient characteristics were generally similar. Table 3: time to recovery of T4/T1 ratio greater than or equal to 0.9 following one injection. BRIDION 4 mg/kg Neostigmine 70 µg/kg p Rocuronium group Recovery time (min): - mean [95% CI] - median [min - max] Vecuronium group Recovery time (min): - mean [95% CI] - median [min - max] n= [ ] 2.7 [ ] n= [ ] 3.3 [ ] n= [ ] 49 [ ] n= [ ] 49.9 [ ] <0.001 <0.001 After one injection, improvement in the median time to recovery of T4/T1 ratio greater than or equal to 0.9 was observed in the BRIDION 4 mg/kg arm versus the neostigmine 70 µg/kg arm. - group pre-treated with rocuronium: 2.7 minutes versus 49.0, p< group pre-treated with vecuronium: 3.3 minutes versus 49.9, p< Immediate reversal: Study Methodology: Phase III open-label randomised parallel-group trial of rocuronium + BRIDION versus succinylcholine + spontaneous recovery, involving 110 patients under general anaesthetic with neuromuscular blockade. Inclusion criteria: Patients aged over 18 years with: - ASA I-II, - under general anaesthetic requiring administration of rocuronium or succinylcholine for short-duration neuromuscular blockade and tracheal intubation, - planned surgical procedure in decubitus position, - BMI < 30. Treatment: - Rocuronium 1.2 mg/kg then BRIDION (16 mg/kg), n = 55, - Succinylcholine 1 mg/kg then spontaneous recovery, n = 55, Primary endpoint: time to recovery of T1 3 greater than or equal to 10% after administration of rocuronium or succinylcholine. RESULTS: ITT analysis (see Table 4) On inclusion, patient characteristics were generally similar. Table 4: Time to recovery of T1 greater than or equal to 10% after administration of rocuronium or succinylcholine. BRIDION 16 mg/kg after rocuronium Spontaneous recovery after succinylcholine 1 mg/kg p n=55 n=55 Recovery time (min): < mean (SD) - median [min - max] 4.4 (0.7) 4.2 [ ] 7.1 (1.6) 7.1 [ ] 3 T1 = time to recovery of first response. T1 10% is defined in relation to the T0 value, obtained before administration of the blockade. 7

8 After one injection, improvement in the median time to recovery of T1 greater than or equal to 10% was observed in the BRIDION 16 mg/kg arm versus the spontaneous recovery arm: 4.2 minutes versus 7.1 minutes, p< Note: as the blocking agents were different in each arm, interpretation of the results is difficult Paediatric population: Study The objective of this study was to evaluate the efficacy of BRIDION at various doses (0.5 mg/kg, 1 mg/kg, 2 mg/kg and 4 mg/kg) in 18 patients under general anaesthetic with neuromuscular blockade induced by rocuronium 0.6 mg/kg. Patients were stratified by age: infants (28 days to 23 months, n=2), children (2-11 years, n=4), adolescents (12-17 years, n=6) and adults (18-65 years, n=6). The results of this study are given in the annexe to this opinion. Given the small numbers of patients included, the results must be interpreted with care Safety Reversal of moderate neuromuscular blockade Study : In this study, 84 patients of 96 (87.5%) experienced at least one adverse event: 41/48 patients (85.4%) in the BRIDION 2 mg/kg arm and 43/48 (89.6%) in the neostigmine 50 µg/kg arm. These events were serious for 5 patients: two in the BRIDION arm (postoperative haemorrhage) and three in the neostigmine arm (infection, acute ischaemia and nausea & vomiting). 24 patients of 96 (25%) experienced an adverse effect: 14/48 patients (29%) in the BRIDION 2 mg/kg arm and 10/48 (21%) in the neostigmine 50 µg/kg arm. The most common effects were: nausea (4 patients versus 4), vomiting (4 versus 0), dry mouth (3 versus 3). Study : In this study, 55 patients of 73 (75.3%) experienced at least one adverse event: 27/34 patients (79.4%) in the BRIDION 2 mg/kg arm and 28/38 (71.8%) in the neostigmine 50 µg/kg arm. 6 patients of 73 (8.2%) experienced an adverse effect: 5 patients in the BRIDION 2 mg/kg arm and 1 in the neostigmine 50 µg/kg arm. The most common effects were: nausea (1 patient versus 1), chills (1 versus 0), tremor (1 versus 0) Reversal of profound neuromuscular blockade: Study In this study, 73/75 patients (97.3%) in the rocuronium arm versus 79/82 (96.3%) in the vecuronium arm experienced at least one adverse event: 36/37 patients (97.3%) and 46/46 (100%) in the BRIDION 4 mg/kg arm and 37/38 (97.4%) and 33/44 (91.7%) in the neostigmine 70 µg/kg arm. These events were serious for 7 patients: 4 in the BRIDION arm (haemorrhage, ileus, atelectasis and renal abscess) and 3 in the neostigmine arm (dyspnoea, gastric perforation and ileus). 41 patients of 157 (26%) experienced an adverse effect: 19/83 patients (22.9%) in the BRIDION 4 mg/kg arm versus 22/82 (26.8%) in the neostigmine 70 µg/kg arm. The most common effects were: nausea (5 patients versus 7), vomiting (3 versus 3), hypertension (3 versus 3) and muscular weakness (3 versus 3). 8

9 Immediate reversal: Study In this study, 103/110 patients (93.6%) experienced at least one adverse event: 52/55 patients (92.9%) in the rocuronium + BRIDION 16 mg/kg arm and 51/55 (94.4%) in the succinylcholine 1 mg/kg + spontaneous recovery arm. 16 patients experienced an adverse event; 8 in the rocuronium + BRIDION 16 mg/kg arm and 8 in the succinylcholine 1 mg/kg + spontaneous recovery arm. The most common effects were: nausea (2 patients versus 1), tremor (1 versus 0), urine retention (1 versus 0) Conclusion The efficacy and safety of BRIDION have been assessed using four phase III studies involving three reversal situations. For routine reversal of moderate neuromuscular blockade (studies and ), improvement in the median time to recovery of T4/T1 ratio greater than or equal to 0.9 was observed in the BRIDION 2 mg/kg arm versus the neostigmine 50 µg/kg arm: - Study : group pre-treated with rocuronium: 1.4 minutes versus 17.6, group pre-treated with vecuronium: 2.1 minutes versus 18.9, p< Study : 1.9 minutes versus 7.2 minutes, p< There are no available studies on the efficacy of BRIDION in the routine reversal of moderate neuromuscular blockade induced by any other agents (atracurium, mivacurium or cisatracurium). For routine reversal of profound neuromuscular blockade (study ), improvement in the median time to recovery of T4/T1 ratio greater than or equal to 0.9 was observed in the BRIDION 4 mg/kg arm versus the neostigmine 70 µg/kg arm: - group pre-treated with rocuronium: 2.7 minutes versus 49.0, p<0.001, - group pre-treated with vecuronium: 3.3 minutes versus 49.9, p< There are no available studies on the efficacy of BRIDION in the routine reversal of profound neuromuscular blockade induced by any other agents (atracurium, mivacurium or cisatracurium). For immediate reversal of blockade (study ), improvement in the median time to recovery of T1 greater than or equal to 10% was observed in the rocuronium + BRIDION 16 mg/kg arm versus the succinylcholine + spontaneous recovery arm: 4.2 minutes versus 7.1 minutes, p< There are no available studies on the efficacy of BRIDION in the immediate reversal of neuromuscular blockade induced by any other agents (pancuronium, vecuronium). The most commonly observed adverse events in these four studies (>10%) were: nausea, vomiting, dizziness. 9

10 4 TRANSPARENCY COMMITTEE CONCLUSIONS 4.1. Actual benefit Neuromuscular blocking agents are used in general anaesthesia to facilitate tracheal intubation and in some surgical procedures that require complete muscular relaxation or absolute immobility. One of the consequences of their use is a residual post-operative blockade, which can potentially be serious and even life-threatening. This product is intended to provide curative treatment. The efficacy/adverse effects ratio for this medicinal product is high. This product is for first-line therapy. There are only therapeutic alternatives in the field of reversal of moderate neuromuscular blockade. Public health benefit: The burden represented by complications of induction of neuromuscular blockade using rocuronium or vecuronium is low, because of the small numbers of patients affected. There is a therapeutic need to improve management of patients who need reversal of blockade, particularly those who need immediate (emergency) reversal; however, this is not a public health need. Given the available data, BRIDION is not expected to have an impact on the wider population in terms of morbidity and mortality. As a result, BRIDION is not expected to benefit public health. The actual benefit of this drug is substantial Improvement in actual benefit BRIDION provides a minor improvement in actual benefit (IAB IV) for therapeutic management: - in planned reversal of neuromuscular blockade following moderate or profound rocuronium- or vecuronium-induced neuromuscular blockade in adults, - in immediate (emergency) reversal of rocuronium-induced blockade in adults, - in routine reversal of rocuronium-induced blockade in children and adolescents Therapeutic use 4,5,6 Indications: In adults, neuromuscular blockade facilitates endotracheal intubation, as long as sufficient blocking agent is injected to obtain complete muscular relaxation and as long as intubation is only attempted after the necessary time has elapsed to allow the blocking agent to take effect. In children, neuromuscular blockade does not make tracheal intubation any easier. There are no studies that show that the incidence of complications related to tracheal intubation is different with or without neuromuscular blockade. 4 "Indications for induction of neuromuscular blockade in anaesthesia" ["Indications de la curarisation en anesthésie"], consensus conference, SFAR (French society for anaesthesia and intensive care), 12 July Meistelman et al. " Perioperative induction of neuromuscular blockade" ["Curarisation peropératoire"], SFAR 2005, "The Essentials" ["les essentiels"]. 6 "Guidelines for Clinical Practice: Sedation, analgesia and neuromuscular blockade in intensive care" ["Recommandations pour la Pratique Clinique Sédation, analgésie et curarisation en réanimation"], SFAR consensus conference,

11 Induction of neuromuscular blockade can be useful in order to prevent sudden movements that could affect the quality of the surgical procedure. Sufficiently deep sedation can in most cases remove the need for neuromuscular blocking agents, the indications for which often need to be re-evaluated. However, this alternative is not always available, either because of poor haemodynamic tolerance, or because of delayed re-awakening. Reversal of blockade: Residual blockade can cause respiratory depression postoperatively. This is defined as a T4/T1 ratio of less than 90%. Checks for residual blockade should be done systematically at the end of procedures, even if a single dose of non-depolarising blocking agent has been given. Clinical tests do not by themselves guarantee the absence of residual neuromuscular blockade; instrumental monitoring is the main tool when checking for reversal of blockade. The main method is the train of four (TOF) involving the thumb adductor, with visual or tactile evaluation of response. The presence of four responses (T1 to T4) to TOF does not constitute a criterion for complete reversal of blockade. In addition, absence of exhaustion must be demonstrated, using double burst stimulation (DBS) or recording of the TOF. Pharmacological reversal of blockade is recommended if complete reversal cannot be demonstrated. It can only be confirmed when there are at least two, and preferably four responses to the TOF. It consists of injection of neostigmine at a dose of µg/kg. Neostigmine is given in combination with atropine at a dose of µg/kg. Pharmacological reversal of blockade is only contrindicated in exceptional circumstances. Reversal of blockade may be delayed by hypothermia, electrolyte and fluid disturbances or drug interference. In the studies submitted as part of the dossier, the efficacy of BRIDION versus neostigmine in management of reversal of blockade following moderate or profound rocuronium- or vecuronium-induced neuromuscular blockade has been demonstrated. The efficacy of BRIDION after induction of neuromuscular blockade with rocuronium versus spontaneous recovery following induction of blockade with succinylcholine has also been established Target Population In adults, the target population for BRIDION consists of patients under general anaesthetic with rocuronium- or vecuronium-induced neuromuscular blockade, who require pharmacological reversal of blockade. The size of this population can be estimated on the basis of the following data: - the number of general anaesthetics administered each year can be estimated at 6.4 millions in France 7, - rocuronium or vecuronium seem to be used in around 150,000 patients, - around 23,000 of these will require reversal of blockade. In the paediatric population, the target population for BRIDION consists of patients under general anaesthetic with rocuronium-induced neuromuscular blockade, who require pharmacological reversal of blockade. The size of this population, according to experts, can be estimated on the basis of the following data: - the number of general anaesthetics administered to paediatric patients each year can be estimated at 1.3 millions in France, - 25% of patients receive blockade, and rocuronium is prescribed in 2% of cases, - Reversal of blockade is suggested in around 50% of cases, The paediatric population can therefore be estimated at 3000 children per year. 7 SFAR (French anaesthesia and intensive care society) press conference 18 September 2003 "Anaesthetic safety: current situation?" ["La sécurité anesthésique : où en est-on?"], Initial results from national surveys: "anaesthesia-linked mortality" and "demographics of anaesthetist and intensivists" 11

12 4.5. Transparency Committee recommendations The Transparency Committee recommends inclusion on the list of medicines approved for use by hospitals and various public services in the marketing authorisation. 12

13 Annexe Summary of results of study Time to recovery of T4/T1 ratio greater than or equal to 0.9 in infants Time to recovery of T4/T1 ratio greater than or equal to 0.9 in children Time to recovery of T4/T1 ratio greater than or equal to 0.9 in adolescents time to recovery of T4/T1 ratio greater than or equal to 0.9 in adults 13

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