Public Assessment Report for paediatric studies submitted in ...

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I. EXECUTIVE SUMMARY SmPC and PL changes are proposed in sections 4.1 and 4.2. The rapporteur considered that the SmPC/PIL in sections 4.1 and 4.2 should be updated with specific wording regarding the use in paediatric population (if not already included). Based on the submitted data the Rapporteur concludes that no wording can be proposed, but that the MAHs should commit to reviewing all available paediatric data and adjusting their text as appropriate through submission of variations to the relevant national competent authorities. It is suggested that following amendments should be implemented in the countries where the respective wordings have not already been included in the SmPCs using variation procedures. PROPOSED CHANGES IN THE SmPC Section 4.1: it is the Rapporteur's opinion that the SmPCs should be amended including a specific paediatric indication for all inhaled and non-inhaled salbutamol formulations and the lower age limit should be mentioned accordingly. Section 4.2: If no lower age limit is specified, the lower age limit should be mentioned depending on the suitability with the different formulations of salbutamol. Summary of outcome No change Change New study data: New safety information: Paediatric information clarified: section(s) 4.1, 4.2. New indication: Note: i) A new paediatric indication as reflected in section 4.1 of the current SmPC guideline and/or ii) addition of a paediatric dose recommendation in section 4.2 for an indication already granted in adult or in one or more subsets or for a new indication. Other relevant sections with regard to the change should be mentioned. EXECUTIVE SUMMARY Salbutamol belongs to drug groups called “relievers”, which are medicinal products used on an as-needed basis to reverse bronchoconstriction. Reliever medicinal products act quickly to relieve bronchoconstriction and its accompanying acute symptoms. Rapid-acting inhaled agonists of the adrenergic β 2 -receptor are the medicinal products of choice for relief of bronchospasm during acute exacerbations of asthma and for the pretreatment of exercise-induced bronchoconstriction. Salbutamol Final Public Assessment Report RO/W/0001/pdWS/001 Page 4/76
Rapid-acting inhaled β 2 -agonists should be used only on an as-needed basis at the lowest required dose and frequency. Increased use, especially daily use, is a warning of deterioration of asthma control and indicates the need to reassess treatment. Similarly, failure to achieve a quick and sustained response to β 2 -agonist treatment, during an exacerbation, mandates medical attention and may indicate the need for short-term treatment with oral glucocorticosteroids. Several MAH (s) have provided a short description of its recommended indications and posology in children. Some variations in the indications and dosage recommendations are noted compared to the currently approved RO SmPCs in accordance with the specific devices (Diskus/Easyhaler, Evohaler, Nebulizer), but separate texts from each MS were not submitted. There is no lower age range by GlaxoSmithKline for Ventolin inhaled formulation. The data package submitted by the MAH (s) under article 45 of the Paediatric Regulation comprises 24 safety and efficacy clinical studies conducted both in children - adolescents and adults, together with a clinical overview report. All of these studies have been performed by several MAH (s). The MAH (s) have also conducted a literature search for publications relevant to paediatric population and has included some published articles as supporting data. The Companies’s view is that no change is necessary as a consequence of the data presented. II. RECOMMENDATION Based on the review of the paediatric data on safety and efficacy, the Rapporteur considers that the paediatric indication for Salbutamol in the symptomatic treatment of conditions with associated reversible airway obstruction, e.g. asthma or chronic obstructive pulmonary disease with a substantial component of reversibility and prevention of asthma attacks induced by exercise or exposure to allergens is confirmed. Although the recommended indication of salbutamol covers both adults and paediatrics (except COPD) the age range limits are not explicitly mentioned in paediatric population for all different formulations of salbutamol. Thus, an explicit wording in section 4.1, respective 4.2 for paediatric population is considered necessary. The specific sub-section of “paediatric population” should always be included and the information given should cover all subsets of the paediatric population depending on the suitability of different formulation of salbutamol. It is the Rapporteur’s opinion that the amendments proposed in section VI of this report should be implemented in the SmPCs, (if not already included). A Type IB variation on the proposed changes to the SmPC/PL should be submitted by the MAH, within 60 days after finalisation of the procedure for medicinal products included in the worksharing, if not already included. For medicinal products with the same active substance and pharmaceutical form, the submission of a type IB variation is requested within 90 days of publication of the public assessment report. The aim of the “EU worksharing project assessment of paediatric data” is to make the paediatric data available for all European health professionals. Based on the review of the presented paediatric data on pharmadynamics, efficacy and safety, it is agreed with the MAH (s) that the data from the submitted studies do not specifically indicate any need of major change of the current paediatric information in the SmPCs. However, the Rapporteur considers that a harmonisation of the SmPCs and PILs throughout Europe in view of the paediatric information would be recommended for consistency between all salbutamol-containing products across the EU. An update of the SmPCs and PILs regarding paediatric population for all formulations which contain salbutamol is needed in order to be in line with the revised SmPC guideline (September 2009) and QRD template. Salbutamol Final Public Assessment Report RO/W/0001/pdWS/001 Page 5/76
Page 1 and 2: Public Assessment Report for paedia
Page 3: Pharmacovigilance and PSUR Name: Da
Page 7 and 8: The MAHs are requested to submit a
Page 9 and 10: Neonatal onset of symptoms (associa
Page 11 and 12: Study Code: RID/CT/84 (D140/B16); D
Page 13 and 14: of predicted FEV1 to be 12%, the re
Page 15 and 16: central laboratory where this clini
Page 17 and 18: DISKUS 200 mcg compared to albutero
Page 19 and 20: Study period 25 Nov 1996 - 28 May 1
Page 21 and 22: Investigational products for this s
Page 23 and 24: 180mcg 1 inhalation of 90mcg (Can B
Page 25 and 26: Efficacy results Primary efficacy v
Page 27 and 28: At Week 4, mean changes from baseli
Page 29 and 30: In the ITT population the daytime a
Page 31 and 32: This study demonstrated similar saf
Page 33 and 34: Protocol deviations were summarised
Page 35 and 36: The overall (based on all evaluable
Page 37 and 38: Three studies regarding the clinica
Page 39 and 40: The improvment in PEF was 51 L. min
Page 41 and 42: eported by the ≤ 6 year age group
Page 43 and 44: suitable for this age because young
Page 45 and 46: In the group treated with salbutamo
Page 47 and 48: common complaints associated with h
Page 49 and 50: although being gradually replaced b
Page 51 and 52: Based on the data submitted, the MA
Page 53 and 54: Inhaled Table 1 Key Differences bet
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GDS wording National SmPCs with sig
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GDS wording National SmPCs with sig
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Question 4 (Rapporteur): With regar
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Question 3 In case of divergences b
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United Kingdom: Salbulin MDPI Novol
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2. Completely depress the coloured
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The harmonised SmPC as outcome of t
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Assessment of the Applicant’s res
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SALBUTAMOL WZF POLFA 2 mg SALBUTAMO
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symptoms. Increased consumption of
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sympathomimetic amines. High doses
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