Shortec 50mg/ml solution for injection or infusion ... · PDF fileMHRA PAR – Shortec 10 mg/ml and 50mg/ml solution for injection or infusion(PL 40 431/0015-0016) 1 . Shortec 10mg/ml

MHRA PAR – Shortec 10 mg/ml and 50mg/ml solution for injection or infusion (PL 40431/0015-0016) 1

Shortec 10mg/ml solution for injection or infusion Shortec 50mg/ml solution for injection or infusion

(oxycodone hydrochloride)

PL 40431/0015-0016

UKPAR

TABLE OF CONTENTS Lay Summary

Page 2

Scientific Discussion

Page 4

Steps Taken for Assessment

Page 12

Summary of Product Characteristics

Page 13

Patient Information Leaflet

Page 14

Labelling Page 15


LAY SUMMARY Shortec 10mg/ml solution for injection or infusion Shortec 50mg/ml solution for injection or infusion

(oxycodone hydrochloride, solution for injection or infusion, 10 mg/ml and 50 mg/ml)

This is a summary of the Public Assessment Report (PAR) for Shortec 10mg/ml and 50mg/ml solution for injection or infusion (PL 40431/0015-0016). It explains how Shortec 10mg/ml and 50mg/ml solution for injection or infusion 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 Shortec 10mg/ml and 50mg/ml solution for injection or infusion. For practical information about using Shortec 10mg/ml and 50mg/ml solution for injection or infusion, patients should read the package leaflet(s) or contact their doctor or pharmacist. What are Shortec 10mg/ml and 50mg/ml solution for injection or infusion and what are they used for? Shortec 10mg/ml and 50mg/ml solution for injection or infusion contain the active substance oxycodone hydrochloride. Shortec 10mg/ml and 50mg/ml solution for injection or infusion are prescribed to relieve moderate to severe pain. These medicines are identical to OxyNorm 10mg/ml and 50mg/ml solution for injection or infusion (PL 16950/0128 and PL 16950/0155), which were authorised in the UK to Napp Pharmaceuticals Limited on 14 April 2003 and 14 January 2009, respectively. Napp Pharmaceuticals Limited has agreed that the scientific data presented for OxyNorm 10mg/ml and 50mg/ml solution for injection or infusion (PL 16950/0128 and PL 16950/0155) can be used for the applications for Shortec 10mg/ml and 50mg/ml solution for injection or infusion. How are Shortec 10mg/ml and 50mg/ml solution for injection or infusion used? Shortec 10mg/ml and 50mg/ml solution for injection or infusion are given as a single injection into a vein or under the skin, or as an infusion into a vein or under the skin. Shortec 10mg/ml and 50mg/ml solution for injection or infusion can only be obtained on prescription. How do Shortec 10mg/ml and 50mg/ml solution for injection or infusion work? The active ingredient oxycodone hydrochloride belongs to a group of medicines called strong analgesics or ‘painkillers’.

How have Shortec 10mg/ml and 50mg/ml solution for injection or infusion been studied? These applications are identical to previously granted applications for OxyNorm 10mg/ml and 50mg/ml solution for injection or infusion (PL 16950/0128 and PL 16950/0155; Napp Pharmaceuticals Limited). The company (Qdem Pharmaceuticals Limited) referred to data provided by Napp Pharmaceuticals Limited for the grant of licences for OxyNorm 10mg/ml and 50mg/ml solution for injection or infusion (PL 16950/0128 and PL 16950/0155) as a basis for the grant of identical licences for Shortec 10mg/ml and 50mg/ml solution for injection or infusion (PL 40431/0015-0016). What are the benefits and risks of Shortec 10mg/ml and 50mg/ml solution for injection or infusion? As Shortec 10mg/ml and 50mg/ml solution for injection or infusion are considered identical to OxyNorm 10mg/ml and 50mg/ml solution for injection or infusion, their benefits and risks are taken as being the same as that for OxyNorm 10mg/ml and 50mg/ml solution for injection or infusion.


Why are Shortec 10mg/ml and 50mg/ml solution for injection or infusion approved? No new or unexpected safety concerns arose from these applications. It was, therefore, considered that the benefits of Shortec 10mg/ml and 50mg/ml solution for injection or infusion outweigh their risks; and the grant of Marketing Authorisations was recommended. What measures are being taken to ensure the safe and effective use of Shortec 10mg/ml and 50mg/ml solution for injection or infusion? A risk management plan has been developed to ensure that Shortec 10mg/ml and 50mg/ml solution for injection or infusion 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 Shortec 10mg/ml and 50mg/ml solution for injection or infusion, including the appropriate precautions to be followed by healthcare professionals and patients. Other information about Shortec 10mg/ml and 50mg/ml solution for injection or infusion Marketing Authorisations were granted in the UK on 04 September 2013.For more information about treatment with Shortec 10mg/ml and 50mg/ml solution for injection or infusion, read the package leaflet(s), or contact your doctor or pharmacist.

This summary was last updated in 11-2013. The full PAR for Shortec 10mg/ml and 50mg/ml solution for injection or infusion follows this summary.


Shortec 10 mg/ml solution for injection or infusion Shortec 50 mg/ml solution for injection or infusion


PL 40431/0015-0016

SCIENTIFIC DISCUSSION

TABLE OF CONTENTS

Introduction

Page 5

Pharmaceutical Assessment

Page 6

Non-clinical Assessment

Page 9

Clinical Assessment

Page 10

Overall Conclusion and Benefit/Risk Assessment Page 11


INTRODUCTION

The MHRA granted Qdem Pharmaceuticals Limited Marketing Authorisations for the medicinal products Shortec 10 mg/ml and 50 mg/ml solution for injection or infusion (PL 40431/0015-0016) on 04 September 2013. The products are prescription-only medicines (POM). Shortec 10 mg/ml and 50 mg/ml solution for injection or infusion are indicated for the treatment of:

• moderate to severe pain in patients with cancer and post-operative pain; • severe pain requiring the use of a strong opioid.

The applications were submitted as abridged applications according to Article 10c of Directive 2001/83/EC, as amended, cross-referring to OxyNorm 10 mg/ml and 50 mg/ml solution for injection or infusion (PL 16950/0128 and PL 16950/0155), which were granted Marketing Authorisations to Napp Pharmaceuticals Limited on 14 April 2003 and 14 January 2009, respectively.

The active ingredient, oxycodone hydrochloride, is an opioid with similarities to morphine and other opioids. Oxycodone hydrochloride is a full opioid agonist with no antagonist properties. It has an affinity for kappa, mu and delta opiate receptors in the brain and spinal cord. Oxycodone hydrochloride is similar to morphine in its action. No new data were submitted nor were they necessary for these simple applications, as the data are identical to those of the previously granted cross-reference products.


PHARMACEUTICAL ASSESSMENT

LICENCE NO: PL 40431/0015-0016 PROPRIETARY NAME(S): Shortec 10 mg/ml solution for injection or infusion

Shortec 50 mg/ml solution for injection or infusion ACTIVE(S): Oxycodone hydrochloride COMPANY NAME: Qdem Pharmaceuticals Limited E.C. ARTICLE: Article 10c of Directive 2001/83/EC, as amended LEGAL STATUS: POM 1. INTRODUCTION These are abridged applications for Shortec 10 mg/ml and 50 mg/ml solution for injection or infusion submitted under Article 10c of Directive 2001/83/EC, as amended. The applications cross-refer to OxyNorm 10mg/ml and 50mg/ml solution for injection or infusion (PL 16950/0128 and PL 16950/0155), which were granted Marketing Authorisations to Napp Pharmaceuticals Limited on 14 April 2003 and 14 January 2009, respectively. The current applications are considered valid. 2. MARKETING AUTHORISATION APPLICATION FORM 2.1 Name(s) The proposed names of the products are Shortec 10 mg/ml and 50 mg/ml solution for injection or infusion. The products have been named in line with current requirements. 2.2 Strength, pharmaceutical form, route of administration, container and pack sizes Each millitre of solution for injection or infusion contains 10 mg or 50 mg of oxycodone hydrochloride. Shortec 10 mg/ml solution for injection or infusion is packaged in 1ml, 2 ml and 20 ml clear glass ampoules. The product in 1 ml and 2 ml ampoules is available in a pack size of 5 ampoules; the product in 20 ml ampoules is available in a pack size of 4 ampoules. Not all pack sizes may be marketed. Shortec 50 mg/ml solution for injection or infusion is packaged in 1ml clear glass ampoules, in a pack size of 5 ampoules. The proposed shelf life for the unopened product is 3 years; the opened product should be used immediately. There are no special storage instructions for the unopened product. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution, dilution, etc., has taken place in controlled and validated aseptic conditions. The packaging, proposed shelf-life and storage conditions are consistent with the details registered for the cross-reference products. 2.3 Legal status On approval, the products will be available as prescription-only medicines (POM). 2.4 Marketing Authorisation Holder/Contact Persons/Company Qdem Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge CB4 0AB. The Qualified Person (QP) responsible for pharmacovigilance is stated and a satisfactory CV has been provided.


2.5 Manufacturers The proposed manufacturing sites are consistent with those registered for the cross-reference products and evidence of Good Manufacturing Practice (GMP) compliance has been provided. 2.6 Qualitative and quantitative composition The proposed compositions are consistent with the details registered for the cross-reference products. 2.7 Manufacturing process The proposed manufacturing process is consistent with the details registered for the cross-reference products and the maximum batch size is stated. 2.8 Finished product/shelf-life specification The proposed finished product specifications are in line with the details registered for the respective cross-reference products. 2.9 Drug substance specification The proposed drug substance specification is consistent with the details registered for the cross-reference products. 2.10 TSE Compliance None of the excipients contains material of animal or human origin. 2.11 Bioequivalence No bioequivalence data are required to support these simple abridged applications, as the proposed products are manufactured to the same formula and utilise the same processes as the reference products OxyNorm 10mg/ml and 50mg/ml solution for injection or infusion (PL 16950/0128 and PL 16950/0155). 3. EXPERT REPORT The applicant cross-refers to the data for OxyNorm 10mg/ml and 50mg/ml solution for injection or infusion (PL 16950/0128 and PL 16950/0155), to which these applications are claimed to be identical. This is acceptable. 4. PRODUCT NAME & APPEARANCE See 2.1 for details of the proposed product names. The appearance of each product is identical to the respective cross-reference product. 5. SUMMARIES OF PRODUCT CHARACTERISTICS (SmPCs) The proposed Summaries of Product Characteristics are consistent with the details registered for the respective cross-reference products. 6. PATIENT INFORMATION LEAFLETS (PILs) AND LABELLING

The Patient Information Leaflets have been prepared in line with the details registered for the cross-reference products.

PIL

User testing of the package leaflets for OxyNorm 10mg/ml and 50mg/ml solution for injection or infusion (PL 16950/0128 and PL 16950/0155) have previously been accepted based on the bridging report provided by Napp Pharmaceuticals Limited making reference to the user-testing of the PIL for Oxycontin 5 mg, 10 mg, 20 mg, 40 mg and 80 mg prolonged release tablets (PL 16950/0097-0100 and PL 16950/0123) as the ‘parent PIL’.


As the leaflet text for Shortec 10 mg/ml and 50 mg/ml solution for injection or infusion and that for OxyNorm 10mg/ml and 50mg/ml solution for injection or infusion (PL 16950/0128 and PL 16950/0155) are considered the same, no further user testing of the leaflets for these products is considered necessary.

The proposed artwork is consistent with the artwork registered for the respective cross-reference products and complies with statutory requirements. In line with current legislation, the applicant has included sufficient space for a standard UK pharmacy dispensing label.

Carton and label

7. CONCLUSION The data submitted with the applications are acceptable. The grant of Marketing Authorisations is recommended.


NON-CLINICAL ASSESSMENT

As these are abridged applications submitted under Article 10c of Directive 2001/83/EC, as amended, no new non-clinical data have been supplied and none are required. The Marketing Authorisation Holder has submitted an acceptable Environmental Risk Assessment, prepared in accordance with CHMP Guideline on Environmental Risk Assessment of Medicinal Products for Human Use (Ref: EMEA/CHMP/SWP/4447/00), which indicates that the products are unlikely to represent a risk to the environment following prescribed usage. The grant of Marketing Authorisations is recommended.


CLINICAL ASSESSMENT

As these are abridged applications submitted under Article 10c of Directive 2001/83/EC, as amended, no new clinical data have been supplied and none are required.

The Marketing Authorisation Holder has provided details of a suitable pharmacovigilance system that fulfils the requirements and provides adequate evidence that they have the services of a qualified person responsible for pharmacovigilance, and have the necessary means for the notification of any adverse reaction suspected of occurring either in the Community or in a third country. An acceptable Risk Management Plan (RMP) has been submitted. The grant of Marketing Authorisations is recommended.


OVERALL CONCLUSION AND BENEFIT/RISK ASSESSMENT

QUALITY The data for these applications are consistent with those previously assessed for the cross-reference products and as such have been judged to be satisfactory. NON-CLINICAL No new non-clinical data were submitted and none are required for applications of this type. EFFICACY These applications are identical to previously granted applications for OxyNorm 10mg/ml and 50mg/ml solution for injection or infusion (PL 16950/0128 and PL 16950/0155). SAFETY No new safety data were supplied or required for these applications. Oxycodone hydrochloride has a well-established safety profile. No new or unexpected safety concerns arise from these applications. PRODUCT LITERATURE The SmPCs, PILs and labelling text are satisfactory, and consistent with those for the cross-reference products. BENEFIT/RISK ASSESSMENT The quality of the products is acceptable, and no new non-clinical or clinical safety concerns have been identified. The applicant’s products are identical to the cross-reference products. Extensive clinical experience with oxycodone hydrochloride is considered to have demonstrated the therapeutic value of the compound. The benefit/risk balance is, therefore, considered to be positive.


Shortec 10 mg/ml solution for injection or infusion Shortec 50 mg/ml solution for injection or infusion


PL 40431/0015-0016

STEPS TAKEN FOR ASSESSMENT

1 The MHRA received the Marketing Authorisation applications on 11 February 2013.

2 Following standard checks and communication with the applicant the MHRA considered the applications valid on 27 March 2013.

3 Following assessment of the applications the MHRA requested further information relating to the dossier on 12 July 2013.

4 The applicant responded to the MHRA’s request, providing further information on the 23 July 2013.

5 The applications were granted on 04 September 2013.


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.


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.


LABELLING




Documents

Shortec 50mg/ml solution for injection or infusion ... · PDF fileMHRA PAR – Shortec 10 mg/ml and 50mg/ml solution for injection or infusion(PL 40 431/0015-0016) 1 . Shortec 10mg/ml