Public Assessment Report. UK National Procedure. (colecalciferol) PL 16508/0047 PL 16508/0048. ProStrakan Ltd.

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1 Public Assessment Report UK National Procedure STEXEROL-D 3 1,000 IU FILM-COATED TABLETS STEXEROL-D 3 25,000 IU FILM-COATED TABLETS (colecalciferol) PL 16508/0047 PL 16508/0048 ProStrakan Ltd. 1

2 LAY SUMMARY Stexerol-D 3 1,000 IU Film-coated Tablets Stexerol-D 3 25,000 IU Film-coated Tablets (colecalciferol) This is a summary of the public assessment report (PAR) for Stexerol-D 3 1,000 IU Film-coated Tablets and Stexerol-D 3 25,000 IU Film-coated Tablets (PL 16508/ ). It explains how Stexerol-D 3 1,000 IU Film-coated Tablets and Stexerol-D 3 25,000 IU Film-coated Tablets were assessed and their authorisation recommended as well as their conditions of use. It is not intended to provide practical advice on how to use the tablets. Stexerol-D 3 1,000 IU Film-coated Tablets and Stexerol-D 3 25,000 IU Film-coated Tablets will be collectively referred to as Stexerol-D 3 Tablets in the remainder of this summary. For practical information about using Stexerol-D 3 Tablets, patients should read the package leaflet or contact their doctor or pharmacist. What are Stexerol-D 3 Tablets and what are they used for? Stexerol-D 3 Tablets are medicines with well-established use. This means that the medicinal use of the active substance of Stexerol-D 3 Tablets has been well-established in the European Union (EU) for at least ten years, with recognised efficacy and an acceptable level of safety. Stexerol-D 3 Tablets are available in two strengths and are used in adults and adolescents over 12 years old to prevent and treat very low levels of vitamin D 3 (deficiency). Stexerol-D 3 Tablets can also be used in combination with other medicines to treat certain bone conditions such as thinning of the bones (osteoporosis). How do Stexerol-D 3 Tablets work? Stexerol-D 3 Tablets contain vitamin D 3 which is essential for healthy bones. Vitamin D 3 belongs to a group of medicines called vitamin supplements which are used to correct and maintain levels of the vitamin in your body. Vitamin D 3 is produced naturally by your skin after exposure to the sun and is also found in some foods. When levels of vitamin D 3 in the body are too low this can cause bones to become fragile. How are Stexerol-D 3 Tablets used? These medicines can only be obtained with a prescription. The tablets can be swallowed whole, or crushed. The dose needed to treat vitamin D 3 deficiency will depend on how low the patient s vitamin D 3 levels are. A doctor will provide advice on the strength and number of tablets to take and how often the patient should take them - usually up to 75,000 IU for adolescents or up to 300,000 IU for adults, which may be spread over several weeks. After this patients may need to take regular doses to maintain vitamin D 3 levels. The recommended dose for prevention of deficiency, and maintenance after treatment of deficiency, is 1,000 IU a day, although in some cases higher doses may be required. A doctor will prescribe the correct dose. When used in addition to specific therapy for osteoporosis the dose in adults is 25,000 IU/month or 2

3 1,000 IU/day. Patients may be asked to take tablets on a monthly basis, for example 25,000 IU once a month (every 28 days). A free reminder service is available to make it easier for patients to remember when to take their monthly tablet. What benefits of Stexerol-D 3 Tablets have been shown in studies? As colecalciferol is a well-known substance and its use in the licensed indications is well established, the applicant has presented data from the scientific literature. The literature provided confirmed the efficacy and safety of colecalciferol for use in the licensed indications. What are the possible side effects of Stexerol-D 3 Tablets? Like all medicines, this medicine can cause side effects, although not everybody gets them. For the full list of side effects reported with Stexerol-D 3 Tablets, see section 4 of the package leaflet, available on the MHRA website For the full list of restrictions, see the package leaflet. Why were Stexerol-D 3 Tablets approved? The MHRA concluded that, in accordance with EU requirements, the benefits of Stexerol-D 3 Tablets outweigh the identified risks and recommended that the products be approved for use. What measures are being taken to ensure the safe and effective use of Stexerol-D 3 Tablets? A risk management plan has been developed to ensure that Stexerol-D 3 Tablets are used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Stexerol-D 3 Tablets, including the appropriate precautions to be followed by healthcare professionals and patients. Known side effects are continuously monitored. Furthermore, new safety signals reported by patients/healthcare professionals will be monitored and reviewed continuously. Other information about Stexerol-D 3 Tablets Marketing Authorisations were granted for Stexerol-D 3 Tablets on 19 November The full PAR for Stexerol-D 3 Tablets follows this summary. For more information about treatment with Stexerol-D 3 Tablets read the package leaflet, or contact your doctor or pharmacist. This summary was last updated in January

4 SCIENTIFIC DISCUSSION TABLE OF CONTENTS I Introduction Page 5 II Quality aspects Page 5 III Non-clinical aspects Page 10 IV Clinical aspects Page 10 V User consultation Page 14 VI Overall conclusion, benefit/risk assessment and recommendation Page 14 4

5 I Introduction Based on the review of the data on quality, safety and efficacy, the Medicines and Healthcare products Regulatory Agency (MHRA) considered that the applications for Stexerol-D 3 1,000 IU Film-coated Tablets and Stexerol-D 3 25,000 IU Film-coated Tablets could be approved. These prescription only medicines (POM) are used in adults, the elderly and adolescents for prevention and treatment of vitamin D deficiency and as an adjunct to specific therapy for osteoporosis in patients with vitamin D deficiency or at risk of vitamin D insufficiency. The applications for Stexerol-D 3 1,000 IU Film-coated Tablets and Stexerol-D 3 25,000 IU Film-coated Tablets were submitted according to Article 10a of Directive 2001/83/EC, as amended, claiming wellestablished use of the active substance, colecalciferol. In its biologically active form vitamin D 3 stimulates intestinal calcium absorption, incorporation of calcium into the osteoid, and release of calcium from bone tissue. In the small intestine it promotes rapid and delayed calcium uptake. The passive and active transport of phosphate is also stimulated. In the kidney, it inhibits the excretion of calcium and phosphate by promoting tubular resorption. The production of parathyroid hormone (PTH) in the parathyroids is inhibited directly by the biologically active form of vitamin D 3. PTH secretion is inhibited additionally by the increased calcium uptake in the small intestine under the influence of biologically active vitamin D 3. No new clinical or non-clinical studies were conducted, which is acceptable given that these are bibliographic applications for products containing an active ingredient of well-established use. A summary of the pharmacovigilance system and a detailed Risk Management Plan (RMP) have been provided with these applications and these are satisfactory. The MHRA has been assured that acceptable standards of Good Manufacturing Practice are in place for this product type at all sites responsible for the manufacture, assembly and batch release of these products. These applications were considered by the Commission on Human Medicines on 15 May 2014 and 19 February The MHRA considered that the applications could be approved and Marketing Authorisations were granted on 19 November II QUALITY ASPECTS II.1 Introduction The 1,000 IU tablets are orange, oval shaped, film-coated tablets of 8.5 mm containing 1,000 IU colecalciferol. The 25,000 IU tablets are orange, capsule shaped, film-coated tablets of 14 mm containing 25,000 IU colecalciferol. The cores of both tablet strengths contain croscarmellose sodium, magnesium stearate, modified maize starch, colloidal anhydrous silica, sucrose, sodium ascorbate, medium chain triglycerides, colloidal silicon dioxide and all-rac-α-tocopherol. The core of the 1,000 IU tablet also contains microcrystalline cellulose and the core of the 25,000 IU tablet also contains mannitol and polacrilin potassium. Both tablet strengths are coated in hypromellose, talc, macrogol 6000 (polyethylene glycol (PEG)), titanium dioxide (E171), yellow iron oxide (E172) and red iron oxide (E172). The 1,000 IU tablets are provided in polyvinyl chloride (PVC)-polyethylene (PE)-polyvinylidene chloride (PVdC)/aluminium blister packs of 28 tablets or high density polyethylene bottles with a 5

6 polypropylene cap containing 56 tablets, inside cardboard cartons. The 25,000 IU tablets are provided in PVC-PE-PVDC/aluminium blister packs of 12 tablets inside a cardboard carton. Not all pack sizes may be marketed. II.2 Drug substance INN/Ph.Eur: Structure: Cholecalciferol concentrate (powder form) Molecular formula: C 27 H 44 O Relative molecular mass: Synthesis of the active substance from the designated starting materials has been adequately described 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 appropriately validated 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 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 supporting a suitable retest period when stored in the proposed packaging. II.3 Medicinal Product Pharmaceutical Development The objective of the development programme was to formulate safe, efficacious and stable film-coated tablets containing 1,000 colecalciferol (equivalent to 25 micrograms of vitamin D 3 ) and 25,000 IU colecalciferol (equivalent to 625 micrograms of vitamin D 3 ). A satisfactory account of the pharmaceutical development has been provided. Manufacturing Process A satisfactory batch formula has been provided for the manufacture of the products, along with an appropriate description of the manufacturing process. Suitable in-process controls are in place to ensure the quality of the finished products. The manufacturing process has been validated using commercial scale batches of both tablet strengths and has shown satisfactory results. 6

7 Finished Product Specification The finished product specifications proposed are acceptable. Test methods have been described that have been adequately validated. Batch data have been provided that comply with the release specification. Certificates of Analysis have been provided for all working standards used. Stability of the product Stability studies were performed, in accordance with current guidelines, on batches of the finished products in the packaging proposed for marketing. The results from these studies support a shelf-life of 18 months when the storage precautions Do not store above 25 C and Store in the original packaging in order to protect from light and moisture are applied. II.4 Discussion on chemical, pharmaceutical and biological aspects It is recommended that Marketing Authorisations are granted for Stexerol-D 3 1,000 IU Film-coated Tablets and Stexerol-D 3 25,000 IU Film-coated Tablets. II.5 Summaries of Product Characteristics (SmPC), Patient Information Leaflet (PIL) and Labels The SmPCs, PIL and labels are satisfactory and, where appropriate, in line with current guidance. In accordance with Directive 2010/84/EU, the current version of the SmPCs and PIL are available on the MHRA website. The approved labels are below: Stexerol-D3 1,000 IU Film-coated Tablets Blister: 7

8 Bottle label: Carton: 8

9 Stexerol-D3 25,000 IU Film-coated Tablets Blister: Carton: 9

10 III NON-CLINICAL ASPECTS The pharmacodynamic, pharmacokinetic and toxicological properties of colecalciferol are well known. No new non-clinical studies have conducted in support of these applications and none are needed. The non-clinical expert report has been written by an appropriately qualified person and is satisfactory, providing a review of the non-clinical aspects of colecalciferol. A suitable justification has been provided for non-submission of an Environmental Risk Assessment. It is recommended that Marketing Authorisations are granted for Stexerol-D 3 1,000 IU Film-coated Tablets and Stexerol-D 3 25,000 IU Film-coated Tablets. IV. CLINICAL ASPECTS IV.1 Introduction No new clinical data have been submitted and none are required for applications of this type. A comprehensive review of the published literature has been provided by the applicant, citing the wellestablished clinical pharmacology, efficacy and safety of colecalciferol. The clinical overview has been written by an appropriately qualified person and is considered acceptable. IV.2 Pharmacokinetics The pharmacokinetics of vitamin D are well known. Vitamin D is well absorbed from the gastro-intestinal tract in the presence of bile. It is hydroxylated in the liver to form 25-hydroxycholecalciferol and then undergoes further hydroxylation in the kidney to form the active metabolite 1,25 dihydroxycholecalciferol (calcitriol). The metabolites circulate in the blood bound to a specific α-globin. Vitamin D and its metabolites are excreted mainly in the bile and faeces. IV.3 Pharmacodynamics In its biologically active form vitamin D 3 stimulates intestinal calcium absorption, incorporation of calcium into the osteoid, and release of calcium from bone tissue. In the small intestine it promotes rapid and delayed calcium uptake. The passive and active transport of phosphate is also stimulated. In the kidney, it inhibits the excretion of calcium and phosphate by promoting tubular resorption. The production of parathyroid hormone (PTH) in the parathyroids is inhibited directly by the biologically active form of vitamin D 3. PTH secretion is inhibited additionally by the increased calcium uptake in the small intestine under the influence of biologically active vitamin D 3. IV.4 Clinical efficacy The applicant has presented a summary of published studies which supports the indications and posologies proposed in the SmPCs for these medicinal products. The well-established use of vitamin D at the doses recommended has been demonstrated. IV.5 Clinical Safety The applicant has presented a summary of studies which supports the safety of the products when used as advised in the SmPCs. IV.6 Risk Management Plan (RMP) and Pharmacovigilance System The applicant has submitted a risk management plan (RMP), in accordance with the requirements of Directive 2001/83/EC, as amended, describing the pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to Stexerol-D 3 1,000 IU Film- 10

11 coated Tablets and Stexerol-D 3 25,000 IU Film-coated Tablets. A summary of safety concerns and planned risk minimisation activities, as approved in the RMP, is listed below: 11

12 12

13 13

14 IV.7 Discussion of the clinical aspects It is recommended that Marketing Authorisations are granted for Stexerol-D 3 1,000 IU Film-coated Tablets and Stexerol-D 3 25,000 IU Film-coated Tablets. V. USER CONSULTATION The package leaflet has been evaluated via a user consultation study, in accordance with the requirements of Articles 59(3) and 61(1) of Directive 2001/83/EC, as amended. The results show that the package leaflet meets the criteria for readability, as set out in the guideline on the readability of the label and package leaflet of medicinal products for human use. VI OVERALL CONCLUSION, BENEFIT/RISK ASSESSMENT AND RECOMMENDATION The quality of the products is acceptable, and no new non-clinical or clinical safety concerns have been identified. Extensive clinical experience with colecalciferol is considered to have demonstrated the therapeutic value of the compound. The benefit-risk assessment is therefore considered to be positive. 14

15 Annex 1 Table of content of the PAR update for MRP and DCP Steps taken after the initial procedure with an influence on the Public Assessment Report Scope Procedure number Product Information affected Date of start of the procedure Date of end of procedure Approval/ non approval Assessment report attached Y/N (version) 15

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