Public Assessment Report. Decentralised Procedure

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1 Public Assessment Report Decentralised Procedure Amlodipine Pfizer 5 mg tablets Amlodipine Pfizer 10 mg tablets Amlodipine Pfizer 5 mg hard capsules Amlodipine Pfizer 10 mg hard capsules Procedure No: UK/H/5552/001-04/DC UK Licence No: PL 00057/ Pfizer Limited

2 Lay Summary Amlodipine Pfizer 5 mg tablets Amlodipine Pfizer 10 mg tablets Amlodipine Pfizer 5 mg hard capsules Amlodipine Pfizer 10 mg hard capsules (amlodipine, as amlodipine besilate) This is a summary of the Public Assessment Report (PAR) for Amlodipine Pfizer 5 mg and 10 mg tablets (PL 00057/ ; UK/H/5552/ /DC) and Amlodipine Pfizer 5 mg and 10 mg hard capsules (PL 00057/ ; UK/H/5552/ /DC). Amlodipine Pfizer 5 mg and 10 mg tablets and will be referred to as Amlodipine Pfizer 5 mg and 10 mg tablets and capsules throughout this report, for ease of reading. It explains how Amlodipine Pfizer 5 mg and 10 mg tablets and capsules 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 Amlodipine Pfizer 5 mg and 10 mg tablets and capsules. For practical information about using Amlodipine Pfizer 5 mg and 10 mg tablets and capsules, patients should read the package leaflets or contact their doctor or pharmacist. What are Amlodipine Pfizer 5 mg and 10 mg tablets and capsules and what are they used for? Amlodipine Pfizer 5 mg and 10 mg tablets and capsules are generic medicines. This means that they are similar to reference medicines, already authorised in the European Union (EU). The reference medicine of Amlodipine Pfizer received the EU approval with the trade name Istin (5 mg and 10 mg tablets) on 18 th September Amlodipine Pfizer 5 mg and 10 mg tablets and capsules are used to treat high blood pressure (hypertension) or a certain type of chest pain called angina, including a rare form of angina called Prinzmetal s or variant angina. How do Amlodipine Pfizer 5 mg and 10 mg tablets and capsules work? Amlodipine Pfizer 5 mg and 10 mg tablets and capsules contain the active substance amlodipine (as amlodipine besilate), which belongs to a group of medicines called calcium antagonists. In patients with high blood pressure these medicines work by relaxing blood vessels, so that blood passes through them more easily. In patients with angina Amlodipine Pfizer 5 mg and 10 mg tablets and capsules work by improving blood supply to the heart muscle, which then receives more oxygen and as a result chest pain is prevented. This medicine does not provide immediate relief of chest pain from angina. How are Amlodipine Pfizer 5 mg and 10 mg tablets and capsules used? Amlodipine Pfizer 5 mg and 10 mg tablets and capsules should be taken once daily at the same time with a drink of water. These medicines can be used before or after food and drinks but should not be taken with grapefruit juice. Please read Section 3 of the package leaflets for detailed information on dosing recommendations, the route of administration and the duration of treatment. The recommended starting dose for adults is 5 mg a day. Depending on the individual patient's response the dose can be increased to 10 mg a day. 2

3 For children and adolescents (6-17 years old), the recommended starting dose is 2.5 mg a day. The maximum recommended dose is 5 mg a day. Amlodipine Pfizer 5 mg tablets can be divided into halves to provide a 2.5 mg dose. Amlodipine Pfizer 2.5 mg capsules are not currently available, and so this lower dose of 2.5 mg is not possible with the capsules. These medicines can only be obtained with a prescription. How have Amlodipine Pfizer 5 mg and 10 mg tablets and capsules been studied? No additional studies were needed as Amlodipine Pfizer 5 mg and 10 mg tablets and capsules are identical to products that have been authorised previously, namely the reference medicines Istin 5 mg and 10 mg tablets and, additionally, Istin 5 mg and 10 mg capsules. The applicant has provided suitable justification to demonstrate similarity between the proposed Amlodipine Pfizer 5 mg and 10 mg tablet and capsule products and the Istin tablet and capsule products. What are the possible side effects of Amlodipine Pfizer 5 mg and 10 mg tablets and capsules? Because Amlodipine Pfizer 5 mg and 10 mg tablets and capsules are generic medicines, their benefits and possible side effects are taken as being the same as those of the reference medicines, Istin 5 mg and 10 mg tablets and Istin 5 mg and 10 mg capsules. For further information, please see the package leaflets. Why are Amlodipine Pfizer 5 mg and 10 mg tablets and capsules approved? It was concluded that, in accordance with EU requirements, Amlodipine Pfizer 5 mg and 10 mg tablets and capsules have been shown to have comparable quality and be bioequivalent to Istin 5 mg and 10 mg tablets. Therefore, the view was that, as for Istin 5 mg and 10 mg tablets, the benefits outweigh the identified risks and Amlodipine Pfizer 5 mg and 10 mg tablets and capsules can be approved for use. What measures are being taken to ensure the safe and effective use of Amlodipine Pfizer 5 mg and 10 mg tablets and capsules? A risk management plan has been developed to ensure that Amlodipine Pfizer 5 mg and 10 mg tablets and capsules are used as safely as possible. Based on this plan, safety information has been included in the Summaries of Product Characteristics (SmPCs) and the package leaflets for Amlodipine Pfizer 5 mg and 10 mg tablets and capsules, 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 and healthcare professionals will be monitored and reviewed continuously, as well. Other information about Amlodipine Pfizer 5 mg and 10 mg tablets and capsules Austria, Finland, Italy and the UK agreed to grant Marketing Authorisations for Amlodipine Pfizer 5 mg and 10 mg tablets on 23 February The Marketing Authorisations in the UK were granted to the Marketing Authorisation Holder (MAH), Pfizer Limited, on 12 March France, Greece and the UK agreed to grant marketing authorisations for Amlodipine Pfizer 5 mg and 10 mg capsules on 23 February The marketing authorisations in the UK were granted to the Marketing Authorisation holder, Pfizer Limited, on 12 March

4 The full PAR for Amlodipine Pfizer 5 mg and 10 mg tablets and capsules follows this summary. For more information about treatment with Amlodipine Pfizer 5 mg and 10 mg tablets and capsules, read the package leaflet or contact your doctor or pharmacist. This summary was last updated in September

5 Table of Contents I Introduction Page 6 II Quality aspects Page 8 III Non-clinical aspects Page 11 IV Clinical aspects Page 11 V User consultation Page 13 VI Overall conclusion, benefit/risk assessment and recommendation Page 13 Table of content of the PAR update for MRP and DCP Page 15 Annex 1 Page 16 5

6 I Introduction Based on the review of the data on quality, safety and efficacy, the Member States have granted Marketing Authorisations (MAs) for the medicinal products Amlodipine Pfizer 5 mg and 10 mg tablets (PL 00057/ ; UK/H/5552/ /DC) and Amlodipine Pfizer 5 mg and 10 mg capsules (PL 00057/ ; UK/H/5552/ /DC). These products are prescription-only medicines (POM), indicated for hypertension, chronic stable angina pectoris and vasospastic (Prinzmetal s) angina. These applications were submitted using the Decentralised Procedures (DCPs), with the UK as Reference Member State (RMS) and Austria, Finland and Italy as Concerned Member States (CMSs) for Amlodipine Pfizer 5 mg and 10 mg tablets (; PL 00057/ ) and France and Greece as CMSs for Amlodipine Pfizer 5 mg and 10 mg capsules (UK/H/5552/03-04/DC; PL 00057/ ). These applications were made under Article 10(1) of Directive 2001/83/EC, as amended, claiming to be generic medicinal products. The reference medicinal products, which have been authorised in accordance with Community provisions in force for not less than 10 years in the European Economic Area (EEA), are Istin 5 mg and 10 mg tablets (PL 00057/ ); these products were authorised to Pfizer Limited in the UK on 18 September Amlodipine Pfizer 5 mg and 10 mg tablets and capsules contain the active ingredient amlodipine, as amlodipine besilate. Amlodipine is an L-type selective calcium channel blocker that inhibits transmembrane influx of calcium ions into cardiac and vascular smooth muscle, thereby causing direct relaxation of the cardiac and vascular smooth muscle (antihypertensive action). Amlodipine further dilates (1) peripheral arterioles and, probably, (2) the main coronary arteries and arterioles, thereby reducing (1) peripheral resistance and (2) increasing myocardial oxygen delivery in patients with coronary artery spasm. No new non-clinical studies were conducted, which is acceptable given that these applications were based on being generic medicinal products of originator products that have been licensed for over 10 years. Since Amlodipine Pfizer 5 mg and 10 mg tablets and capsules are intended for generic substitution, these will not lead to an increased exposure to the environment. An Environmental Risk Assessment (ERA) is, therefore, not deemed necessary. No new clinical data were provided with these applications, which is acceptable for applications of this type. An acceptable justification to waive performing a bioequivalence study has been provided. The RMS has been assured that acceptable standards of Good Manufacturing Practice (GMP) are in place for this product type 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. 6

7 For manufacturing sites outside the Community, the RMS has accepted copies of current GMP Certificates of satisfactory inspection summary reports issued by the inspection services of the MHRA as certification that acceptable standards of GMP are in place at those non-community sites. A Risk Management Plan (RMP) and a summary of the pharmacovigilance system have been provided with these applications and these are satisfactory. The RMS and CMSs considered that these applications could be approved at the end of procedure (Day 207) on 23 February After a subsequent national phase, licences were granted in the UK to Pfizer Limited on 12 March

8 II Quality aspects II.1 Introduction These applications were submitted according to Article 10(1) of Directive 2001/83/EC, as amended. The applicant has specified Istin 5 mg and 10 mg tablets (PL 00057/ ) as the EU reference medicinal product (MA Holder: Pfizer Limited). Amlodipine Pfizer 5 mg and 10 mg tablets Amlodipine Pfizer 5 mg and 10 mg tablets are formulated as white to off-white, emerald-shaped tablets. Amlodipine Pfizer 5 mg tablets are engraved with AML 5 and a breaker score on one side, and either the Pfizer logo or left blank on the other side. The 5 mg tablet can be divided into equal halves. Amlodipine Pfizer 10 mg tablets are engraved with AML 10 on one side, and either the Pfizer logo or left blank on the other side. Each Amlodipine Pfizer 5 mg and 10 mg tablet contains 5 mg and 10 mg, respectively, of the active ingredient amlodipine (as amlodipine besilate). The excipients present in each tablet are: microcrystalline cellulose, calcium hydrogen phosphate anhydrous, sodium starch glycolate Type A and magnesium stearate. The 5 mg and 10 mg tablets are packed in: - Polyvinyl chloride-polyvinylidene chloride/aluminium (PVC-PVdC/Aluminium) foil blisters containing 4, 10, 14, 20, 28, 30, 50, 60, 90 (10 mg strength only), 98, 100, 300 and 500 tablets. - PVC-PVdC/Aluminium foil blisters in calendar packs containing 28 and 98 tablets - PVC-PVdC/Aluminium foil blister strips containing 50 x 1 and 500 x 1 tablets Amlodipine Pfizer 5 mg and 10 mg capsules Amlodipine Pfizer 5 mg capsules are formulated as yellow and white hard capsules with a black imprint AML 5 on one side and the Pfizer logo on the other. Amlodipine Pfizer 10 mg capsules are formulated as grey hard capsules with a black imprint AML 10 on one side and the Pfizer logo on the other. Each Amlodipine Pfizer 5 mg and 10 mg capsule contains 5 mg and 10 mg, respectively, of the active ingredient amlodipine (as amlodipine besilate). The excipients present in the hard capsule content of each 5 mg and 10 mg capsule are: microcrystalline cellulose (E 460), maize starch and magnesium stearate. The excipients present in the hard capsule shell of the 5 mg capsule are: gelatin, quinoline yellow (E 104), titanium dioxide (E 171) and a printing ink (shellac glaze (E 904) and black iron oxide (E 172)). The excipients present in the hard capsule shell of the 10 mg capsule are: gelatin, black iron oxide (E 172), yellow iron oxide (E 172), titanium dioxide (E 171) and a printing ink (shellac glaze (E 904) and black iron oxide (E 172)). 8

9 The capsules are packed in: - PVC-PVdC/Aluminium foil blisters containing 14, 28, 30, 56, 90, 98 and 100 capsules - PVC-PVdC/Aluminium foil blister strips containing 28 x 1 (5 mg only), 30 x 1, 56 x 1 and 100 x 1 capsules II.2 Drug Substance Amlodipine Besilate INN: amlodipine besilate Chemical Name: 3-Ethyl 5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2- chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate Structure: Molecular formula: Molecular weight: Appearance: Solubility: C 26 H 31 ClN 2 O 8 S g/mol white to almost white powder. slightly soluble in water, freely soluble in methanol, sparingly soluble in anhydrous ethanol, slightly soluble in 2-propanol. Amlodipine besilate is the subject of a European Pharmacopoeia monograph. All aspects of the manufacture and control of the active substance, amlodipine besilate, are covered by an EDQM Certificate of Suitability. II.3 Medicinal Product Pharmaceutical development Amlodipine Pfizer 5 mg and 10 mg tablets and Amlodipine Pfizer 5 mg and 10 mg capsules are duplicates of Istin 5 mg and 10 mg tablets (PL 00057/ ) and Istin 5 mg and 10 mg capsules (PL 00057/ ). The development of the products has been adequately described. The choice of excipients is justified and their functions explained. The applicant applied for a waiver of a bioequivalence study. They provided a justification detailing the BCS (Biopharmaceutics Classification System) I classification of amlodipine and provided multi-point dissolution profile data demonstrating similarity of the reference products (Istin 5 mg and 10 mg tablets) and test products (Amlodipine 5 mg and 10 mg tablets and capsules) in 3 different physiological media. The applicant also provided dissolution data for the duplicate capsule products that have already been authorised, Istin 5 mg and 10 mg capsules. There was >85% release in all three different physiological dissolution media for the capsules (Amlodipine Pfizer 5 mg and 10 mg capsules and Istin 5 mg and 10 mg capsules) and in two of the three different physiological dissolution media 9

10 for the tablets (Amlodipine Pfizer 5 mg and 10 mg tablets and Istin 5 mg and 10 mg tablets). For the third dissolution media, similarity was shown between Amlodipine Pfizer 5 mg and 10 mg tablets and Istin 5 mg and 10 mg tablets by F2 values of between 50 and 100. The discussion was considered acceptable and a waiver of bioequivalence was accepted. All the excipients used in the manufacture of the proposed formulations, other than the printing ink, black iron oxide (E172), yellow iron oxide (E172) and quinolone yellow (E104), comply with their respective European Pharmacopoeia monographs. The printing ink complies with a satisfactory in-house specification and the black iron oxide (E172), yellow iron oxide (E172) and quinolone yellow (E104) comply with the European Commission Directive 2008/128/EC. Satisfactory certificates of analysis have been provided for all excipients showing compliance with their proposed specifications. None of the excipients are sourced from animal or human origin, except for gelatin. The suppliers of the gelatin have provided certificates of suitability from the European Directorate for the Quality of Medicines and Healthcare (EDQM) to show that it is manufactured in line with current European guidelines concerning the minimising of risk of transmission of Bovine Spongiform Encephalopathy/Transmissible Spongiform Encephalopathies (BSE/TSE). No genetically modified organisms (GMO) have been used in the preparation of these excipients. Manufacture of the product s Satisfactory batch formulae have been provided for the manufacture of the finished products, together with appropriate accounts of the manufacturing processes. Validation data were provided for the manufacturing processes. Reference was also made to satisfactory validation data for the manufacture of the identical products Istin 5 mg and 10 mg tablets and capsules, which are currently authorised. Product Specifications The finished product specifications are satisfactory. Satisfactory batch analyses for at least two batches of each strength finished product were performed. Certificates of analysis have been provided for all working standards used. Stability of the products Stability studies were performed in accordance with current guidelines on batches of the finished product, packed in the packaging proposed for marketing. The data from the studies of Amlodipine Pfizer 5 mg and 10 mg tablets support a shelf-life of 4 years, with the storage precaution Do not store above 25 C. The data from the studies of Amlodipine Pfizer 5 mg and 10 mg capsules support a shelf-life of 5 years, with the storage precaution Do not store above 30 C. Suitable post approval stability commitments have been provided. II.4 Discussion on chemical, pharmaceutical and biological aspects The grant of Marketing Authorisations is recommended. 10

11 III Non-clinical aspects The pharmacodynamic, pharmacokinetic and toxicological properties of amlodipine besilate are well-known. As this active substance is a widely used, well-known active substance, the applicant has not provided additional studies and further studies are not required. The non-clinical overview based on a literature review is, thus, appropriate. The non-clinical overview has been written by an appropriately qualified person. The non-clinical overview on the pharmacology, pharmacokinetics and toxicology is adequate. Since Amlodipine Pfizer 5 mg and 10 mg tablets and capsules are intended for generic substitution, they will not lead to an increased exposure to the environment. An environmental risk assessment is, therefore, not deemed necessary. IV Clinical aspects IV.1 Introduction No new clinical data have been submitted in support of this application which can be accepted in light of the BCS biowaiver. The applicant s clinical overview has been written by an appropriately qualified person and is considered acceptable. IV.2 Pharmacokinetics The applicant has provided a biowaver, in lieu of a bioequivalence study. A satisfactory discussion on the BCS classification (BCS I, highly soluble, highly permeable) was provided, along with acceptable comparative dissolution data showing immediate and comparable release to the reference products. A waiver for a bioequivalence study can, therefore, be applied. IV.3 Pharmacodynamics No new pharmacodynamics data are required for these applications and none have been submitted. IV.4 Clinical efficacy No new clinical efficacy data are required for these applications and none have been submitted. IV.5 Clinical safety No new data have been provided and none are required for these applications. IV.6 Risk Management Plan (RMP) The marketing authorisation holder has submitted an 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 Amlodipine Pfizer 5 mg and 10 mg tablets and capsules. A summary of safety concerns and planned risk minimisation activities, as approved in the RMP, is listed below: 11

12 Planned risk minimisation activities 12

13 IV.7 Discussion on the clinical aspects The grant of marketing authorisations is recommended for these applications. V User consultation A user consultation with target patient groups on the package information leaflet (PIL) has been performed on the basis of a bridging report making reference to Istin 5 mg and 10 mg tablets. The bridging report submitted by the applicant is acceptable. VI Overall conclusion, benefit/risk assessment and recommendation The quality of these products is acceptable, and no new non-clinical or clinical safety concerns have been identified. A biowaver has been requested and is accepted based on suitable discussion of amlodipine under BCS I classification, with comparative dissolution data. Therefore, the well-established positive benefit/risk analysis of the reference Istin 5 mg and 10 mg tablets is applicable for these generic products as well. The applications contain an adequate review of published clinical data. There are no major objections to approval of these generic products on clinical grounds. The benefit/risk balance of these products is considered favourable. 13

14 The Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL) and labelling are satisfactory, in line with current guidelines and consistent with the reference products. In accordance with Directive 2012/84/EU, the current approved UK versions of the SmPCs and PILs for these products are available on the MHRA website. The current approved UK labelling is available in Annex 1. 14

15 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 (Type II variations, PSURs, commitments) The following table lists a non-safety update to the Marketing Authorisations for these products that has been approved by the MHRA since the products were first licensed. The table includes updates that are detailed in the annex to this PAR. This is not a complete list of the post-authorisation changes that have been made to these Marketing Authorisations. Scope To update sections 2, 3, 4.2, 4.4, 4.5, 4.8, 5.1, 5.2 and 6.4 of the SmPC in line with the reference product, Istin/Norvasc, and in line with the QRD template. Consequently, the label and leaflet have been updated Procedure numbers UK/H/5552/ /1B/001 Product informati on affected SmPC, PIL and Labelling Date of start of the procedures Date of end of procedures 12/06/ /08/2015 (UK/H/555 2/001-02/1B/001) 21/08/2015 (UK/H/555 2/003-04/1B/001) Approval / non approval Approved Assessme nt report attached Y/N (version) Yes 15

16 Annex 1 Reference: PL 00057/ ; PL 00057/ ; PL 00057/ ; PL 00057/ Product: capsules Amlodipine Pfizer 5 mg and 10 mg Tablets/hard Marketing Authorisation Holder: Pfizer Limited Active Ingredient: amlodipine besilate Reason: To update sections 2, 3, 4.2, 4.4, 4.5, 4.8, 5.1, 5.2 and 6.4 of the Summary of Product Characteristics (SmPC) in line with the reference product, Istin/Norvasc, and in-line with the quality review document (QRD) template. Consequently, the Patient Information Leaflet (PIL) and leaflet have been updated. Supporting evidence The applicant has submitted updated sections of the SmPCs, PIL and labelling. Evaluation The amended sections of the SmPCs, PIL and labelling are satisfactory. Conclusion The variations were approved on 18 August 2015 (UK/H/5552/001-02/1B/001) and 21 August 2015 (UK/H/5552/003-04/1B/001) and the updated SmPC fragments, PILs and labelling have been incorporated into these Marketing Authorisations. The proposed changes are acceptable. Following approval of the variations on 18 August 2015 (UK/H/5552/001-02/1B/001) and 21 August 2015 (UK/H/5552/003-04/1B/001) the SmPCs and PIL were updated. In accordance with Directive 2010/84/EU, the current granted UK SmPCs and PIL are available on the MHRA website. The current approved UK labelling is presented below. 16

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