Public Assessment Report. Decentralised Procedure

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1 Public Assessment Report Decentralised Procedure Thorens I.U. /ml oral drops, solution Thorens I.U. /2.5 ml oral solution Deltius I.U. /ml oral drops, solution Deltius I.U. /2.5 ml oral solution Cholecalciferol (Vitamin D 3 ) Procedure No: UK Licence No: PL 13297/ Italfarmaco S.p.A. 1

2 LAY SUMMARY On 27 August 2013, the Medicines and Healthcare products Regulatory Agency (MHRA) granted Marketing Authorisations to Italfarmaco S.p.A. for the medicinal products Thorens/Deltius I.U. /ml oral drops, solution (PL 13297/0001 and 0003; UK/H/ /001/DC) and Thorens/Deltius I.U. /2.5 ml oral solution (PL 13297/0002 and 0004; UK/H/ /002/DC). These are prescription-only medicines (POM). The products may be referred to as Thorens/Deltius oral drops, solution and oral solution in this report. Thorens/Deltius oral drops, solution and oral solution contain the active ingredient, cholecalciferol (vitamin D 3 ). Vitamin D can be found in some foods and is also produced by the body when skin is exposed to sunlight. Vitamin D inhibits the excretion of calcium by the kidneys and it stimulates the absorption of calcium in the intestine and it helps build bones. Thorens/Deltius oral drops, solution and oral solution are used: to prevent vitamin D deficiency when there is a significant risk of deficiency or an increased demand for vitamin D; with other medicines to treat certain bone conditions, such as thinning of the bone (osteoporosis); to treat vitamin D deficiency that has been confirmed by laboratory tests. No new or unexpected safety concerns arose from these applications and it was therefore judged that the benefits of taking Thorens/Deltius oral drops, solution and oral solution outweigh the risks, and Marketing Authorisations were granted. 2

3 TABLE OF CONTENTS Module 1: Information about the initial procedure Page 4 Module 2: Summary of Product Characteristics Page 5 Module 3: Patient Information Leaflet Page 6 Module 4: Labelling Page 7 Module 5: Scientific discussion during initial procedure Page 13 I Introduction II About the product III Scientific overview and discussion III 1 Quality aspects III 2 Non-clinical aspects III 3 Clinical aspects IV Overall conclusion and benefit/risk assessment Module 6: Steps taken after initial procedure Page 19 3

4 Module 1 Information about the initial procedure Product Name UK/H/5176/001/DC: Thorens I.U. /ml oral drops, solution UK/H/5176/002/DC: Thorens I.U. /2.5 ml oral solution UK/H/5177/001/DC: Deltius I.U. /ml oral drops, solution UK/H/5177/002/DC: Deltius I.U. /2.5 ml oral solution Type of Application Well-established use, Article 10a Active Substance(s) Cholecalciferol (Vitamin D 3 ) Form(s) Strength MA Holder Reference Member State (RMS) Concerned Member States (CMS) Oral drops, solution and oral solution Oral drops, solution; 1 ml (50 drops) contains I.U. cholecalciferol (vitamin D 3 ), equivalent to 0.25 mg. 1 drop contains 200 I.U. cholecalciferol (vitamin D 3 ). Oral solution; 1 ml contains I.U. cholecalciferol (vitamin D 3 ), equivalent to 0.25 mg Italfarmaco S.p.A. Viale Fulvio Testi, Milano, Italy UK UK/H/5176/ /DC: Ireland and Belgium UK/H/5177/ /DC: Spain, France, Portugal and Greece Procedure Numbers Timetable Day August

5 Module 2 Summary of Product Characteristics In accordance with Directive 2010/84/EU, the Summaries of Product Characteristics (SmPCs) for products granted Marketing Authorisations at a national level are available on the MHRA website. 5

6 Module 3 Patient Information Leaflet In accordance with Directive 2010/84/EU, the Patient Information Leaflets (PILs) for products granted Marketing Authorisations at a national level are available on the MHRA website. 6

7 Module 4 Labelling 7

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13 Module 5 Scientific discussion during initial procedure I INTRODUCTION Based on the review of the data on quality, safety and efficacy, the member states considered that the applications for Thorens/Deltius I.U. /ml oral drops, solution (PL 13297/0001 and 0003; UK/H/ /001/DC) and Thorens/Deltius I.U. /2.5 ml oral solution (PL 13297/0002 and 0004; UK/H/ /002/DC) could be approved. The products are prescription-only medicines (POM) and are indicated: for the prevention and treatment of vitamin D deficiency; as an adjunct to specific therapy for osteoporosis in patients with vitamin D deficiency or at risk of vitamin D insufficiency. The active ingredient, cholecalciferol (Vitamin D 3 ), is produced by the skin under ultraviolet B (UVB) irradiation of the precursor 7-dehydrocholesterol. Vitamin D 3 is then hydroxylated in the liver into 25- hydroxyvitamin D 3 (25(OH)D). A second hydroxylation takes place in the kidneys, where 25(OH)D is converted into 1,25-dihydroxyvitamin D 3 (1,25(OH) 2 D), the activated form of Vitamin D. Vitamin D supplementation may correct a deficiency of Vitamin D and increase intestinal absorption of calcium. The physiological role of Vitamin D is that of a regulator of calcium homeostasis, and of phosphate metabolism. Vitamin D acts to maintain normal concentrations of calcium and phosphate in plasma by (a) facilitating their absorption from the small intestine, (b) enhancing their mobilisation from bone, and (c) decreasing their excretion by the kidney. The applications were submitted using the Decentralised Procedure (DCP), with the UK as Reference Member State (RMS) with Ireland and Belgium (UK/H/5176/ /DC) and Spain, France, Portugal and Greece (UK/H/5177/ /DC) as Concerned Member States (CMS). The applications were submitted under Article 10a of Directive 2001/83/EC, as amended, claiming to be applications for products containing an active substance of well-established use. Cholecalciferol is a well-established active substance in a variety of different pharmaceutical presentations. Bibliographic literature data have been submitted to support these applications. No new non-clinical or clinical studies were conducted for these applications, which is acceptable given that these are bibliographic applications for products containing an active ingredient of well-established use. The RMS has been assured that acceptable standards of Good Manufacturing Practice (GMP) are in place at all sites responsible for the manufacture, assembly and batch release of these products. For manufacturing sites within the Community, the RMS has accepted copies of current manufacturer authorisations issued by inspection services of the competent authorities as certification that acceptable standards of GMP are in place at those sites. The RMS and CMS considered that the applications could be approved at the end of procedure (Day 210) on 07 August After a subsequent national phase, licences were granted in the UK on 27 August

14 II. ABOUT THE PRODUCT Name of the product in the Reference Member State Name(s) of the active substance(s) (INN) Pharmacotherapeutic classification (ATC code) Pharmaceutical form(s) and strength(s) UK/H/5176/001/DC: Thorens I.U. /ml oral drops, solution UK/H/5176/002/DC: Thorens I.U. /2.5 ml oral solution UK/H/5177/001/DC: Deltius I.U. /ml oral drops, solution UK/H/5177/002/DC: Deltius I.U. /2.5 ml oral solution Cholecalciferol (Vitamin D 3 ) Vitamin D and analogues, cholecalciferol (ATC code: A11CC05) Oral drops, solution; 1 ml (50 drops) contains I.U. cholecalciferol (vitamin D 3 ), equivalent to 0.25 mg 1 drop contains 200 I.U cholecalciferol (vitamin D 3 ) Oral solution; 1 ml contains I.U. cholecalciferol (vitamin D 3 ), equivalent to 0.25 mg Reference number(s) for the Decentralised Procedure Reference Member State (RMS) United Kingdom Concerned Member State (CMS) UK/H/5176/ /DC: Ireland and Belgium UK/H/5177/ /DC: Spain, France, Portugal and Greece Marketing Authorisation Number PL 13297/ Name and address of the Italfarmaco S.p.A. authorisation holder Viale Fulvio Testi, Milano, Italy III SCIENTIFIC OVERVIEW AND DISCUSSION III.1 QUALITY ASPECTS ACTIVE SUBSTANCE INN: Cholecalciferol (Vitamin D 3 ) Compendial name (Ph. Eur.) Cholecalciferol Chemical Name: (5Z,7E)-9,10-Secocholesta-5,7,10(19)-trien-3β ol; 9,10-Secocholesta-5,7,10(19)-trien-3-ol, (3β,5Z,7E) Molecular formula: C 27 H 744 O Structure: Molecular mass: Appearance: White to almost white crystalline powder, practically odourless Solubility: Insoluble in water (less than 1 mg/l at 20 C), freely soluble in acetone, ethanol 96%, chloroform, ether and in fatty oils. Cholecalciferol is the subject of a European Pharmacopoeia monograph. 14

15 Synthesis of the active substance from the designated starting materials has been described adequately and appropriate in-process controls and intermediate specifications are applied. Satisfactory specification tests are in place for all starting materials and reagents and these are supported by relevant Certificates of Analysis. Appropriate proof-of-structure data have been supplied. All potential known impurities have been identified and characterised. An appropriate specification is provided for the active substance. Analytical methods have been validated appropriately and are satisfactory for ensuring compliance with the relevant specifications. Batch analysis data are provided that comply with the proposed specification. Satisfactory Certificates of Analysis have been provided for all working reference standards. Suitable specifications have been provided for all packaging used. The primary packaging has been shown to comply with current guidelines concerning contact with foodstuff. Appropriate stability data have been generated to support the retest period when stored in the proposed packaging. MEDICINAL PRODUCT Other Ingredient Refined olive oil is the only pharmaceutical excipient. Appropriate justification for the inclusion of this excipient has been provided. Refined olive oil complies with its respective European Pharmacopoeia monograph. A satisfactory Certificate of Analysis has been provided, showing compliance with the proposed specification. Refined olive oil does not contain materials of animal or human origin. No genetically modified organisms (GMO) have been used in the preparation of refined olive oil. Pharmaceutical Development The objective of the development programme was to formulate safe, efficacious, stable, oral drops, solutions and oral solutions of cholecalciferol. Suitable pharmaceutical development data have been provided for these applications. Manufacturing Process Satisfactory batch formulae have been provided for the manufacture of the products, along with an appropriate account of the manufacturing process. The manufacturing process has been validated with full production-scale batches and has shown satisfactory results. Control of Finished Product The finished product specifications are acceptable. Test methods have been described and have been validated adequately, as appropriate. Batch data have been provided that comply with the release specifications. Certificates of Analysis have been provided for all working reference standards used. Container-Closure System Thorens/Deltius I.U. /ml oral drops, solution are packaged in 20 ml amber Type III glass bottles intended for multidose use containing 10 ml of oral drops solution (corresponding to 500 drops), sealed with childproof polypropylene caps. The products are supplied with a dropper applicator cap with a colourless type II glass stem and polypropylene cap. Thorens/Deltius I.U. /ml oral drops, solution are packed with the Patient Information Leaflet into cardboard cartons, in packs containing 1 bottle and 1 dropper applicator cap. 15

16 Thorens/Deltius I.U. /2.5ml oral solution are packaged in 5 ml amber Type III glass bottles intended for single dose use containing 2.5 ml of oral solution, sealed with caps made of polypropylene and polyethylene. The product is packed with the Patient Information Leaflet into cardboard cartons, in pack sizes of 1 and 4 single dose bottles. Satisfactory specifications and Certificates of Analysis for the primary packaging material have been provided. All primary packaging is controlled to European Pharmacopoeia standards and complies with guidance concerning materials in contact with foodstuff. Stability of the Product Finished product stability studies were performed in accordance with current guidelines on batches of finished product in the packaging proposed for marketing. Based on the results, the following shelf lives and storage conditions have been accepted: Thorens/Deltius I.U. /ml oral drops, solution: a shelf life of 3 years for the unopened product and 6 months for the opened product, with the storage conditions Do not store above 30 C. Do not freeze or refrigerate. Keep the bottle in the outer carton in order to protect from light. Thorens/Deltius I.U. /2.5 ml oral solution: a shelf life of 4 years, with the storage conditions Do not store above 30 C. Do not freeze or refrigerate. Keep the bottle in the outer carton in order to protect from light. Suitable post approval stability commitments have been provided to continue stability testing on batches of finished product. Bioequivalence/Bioavailability A bioequivalence study was not necessary to support applications of this type. Summary of Product Characteristics (SmPC), Product Information Leaflets (PILs) and Labels The SmPCs, PILs and labels are satisfactory from a pharmaceutical perspective. A package leaflet has been submitted for Thorens I.U. /ml oral drops, solution to the MHRA along with results of consultations with target patient groups ( user testing ), in accordance with Article 59 of Council Directive 2001/83/EC, as amended. The results indicate that the package leaflet is well-structured and organised, easy to understand and written in a comprehensive manner. The test shows that the patients/users are able to act upon the information that the leaflet contains. User testing of the package leaflets for Deltius I.U. /ml oral drops, solution, Thorens I.U. /2.5 ml oral solution and Deltius I.U. /2.5 ml oral solution has been accepted based on the bridging reports provided, making reference to the successful user-testing of the parent PIL for Thorens I.U. /ml oral drops, solution. Marketing Authorisation Application (MAA) Forms The MAA forms are satisfactory from a pharmaceutical perspective. Expert Report (Quality Overall Summary) The quality overall summary has been written by an appropriately qualified person and is a suitable summary of the pharmaceutical aspects of the dossier. Conclusion The grant of Marketing Authorisations is recommended. 16

17 III.2 NON-CLINICAL ASPECTS The pharmacodynamic, pharmacokinetic and toxicological properties of cholecalciferol are well-known. No new non-clinical data have been submitted and none are required. The applicant s non-clinical expert report has been written by an appropriately qualified person and is satisfactory, providing an appropriate review of the relevant non-clinical pharmacology, pharmacokinetics and toxicology. A suitable justification has been provided for non-submission of an Environmental Risk Assessment. The grant of Marketing Authorisations is recommended. III.3 CLINICAL ASPECTS Clinical Pharmacololgy No new clinical pharmacology data have been submitted and none are required for applications of this type. The clinical pharmacology of cholecalciferol is well-known. Efficacy No new efficacy data have been submitted and none are required for applications of this type. The clinical efficacy of cholecalciferol is well-established. Safety No new safety data were supplied or required for these bibliographic applications. Safety is adequately reviewed in the clinical overview. The safety profile of cholecalciferol is well-known. Summaries of Product Characteristics (SmPCs), Patient Information Leaflets (PILs) and Labels The SmPCs, PILs and labels are acceptable from a clinical perspective. The PILs are consistent with the details in the SmPCs and in line with the current guidance. The labelling is in line with the current guidance. Clinical Expert Report (Clinical Overview) The clinical overview has been written by an appropriately qualified physician and is a suitable summary of the clinical aspects of the dossier. Pharmacovigilance System and Risk Management Plan The Pharmacovigilance System, as described by the MAH, fulfils the requirements and provides adequate evidence that the MAH has the services of a qualified person responsible for pharmacovigilance, and has the necessary means for the notification of any adverse reaction suspected of occurring either in the Community or in a third country. Suitable justification has been provided for not submitting a Risk Management Plan for these applications. Conclusion The grant of Marketing Authorisations is recommended. IV OVERALL CONCLUSION AND BENEFIT/RISK ASSESSMENT QUALITY The important quality characteristics of Thorens/Deltius 10,000 I.U. /ml oral drops, solution and Thorens/Deltius I.U. /2.5 ml oral solution are well-defined and controlled. The specifications and batch analytical results indicate consistency from batch to batch. There are no outstanding quality issues that would have a negative impact on the benefit/risk balance. 17

18 NON-CLINICAL No new non-clinical data were submitted and none are required for applications of this type. A non-clinical overview has been provided by an appropriately qualified person that consists of a review of the published literature. EFFICACY No new clinical data were submitted and none were required for applications of this type. The published literature supports the efficacy of the products in the proposed indications. The efficacy of cholecalciferol is well-known. The presented evidence for well-established use of the active substance is sufficient. SAFETY The safety profile of cholecalciferol is well-known. The literature review identified no new or unexpected safety issues or concerns. PRODUCT LITERATURE The approved SmPCs are satisfactory. The PILs and labelling are satisfactory, and consistent with the approved SmPCs. BENEFIT/RISK ASSESSMENT The quality of the products is acceptable, and no new non-clinical or clinical safety concerns have been identified. Cholecalciferol is a well-known active substance. Extensive clinical experience with cholecalciferol is considered to have demonstrated the therapeutic value of the compound. The benefit/risk balance is therefore considered to be positive. 18

19 Module 6 STEPS TAKEN AFTER INITIAL PROCEDURE - SUMMARY Date submitted Application type Scope Outcome 19

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