PRAC recommendations on signals
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1 14 September 2017 EMA/PRAC/407007/2017 Corr 1 Pharmacovigilance Risk Assessment Committee (PRAC) Adopted at the 29 August-1 September 2017 PRAC meeting This document provides an overview of the recommendations adopted by the Pharmacovigilance Risk Assessment Committee (PRAC) on the signals discussed during the meeting of 29 August-1 September 2017 (including the signal European Pharmacovigilance Issues Tracking Tool [EPITT] 2 reference numbers). PRAC recommendations to provide supplementary information are directly actionable by the concerned marketing authorisation holders (s). PRAC recommendations for regulatory action (e.g. amendment of the product information) are submitted to the Committee for Medicinal Products for Human Use (CHMP) for endorsement when the signal concerns Centrally Authorised Products (CAPs), and to the Co-ordination Group for Mutual Recognition and Decentralised Procedures Human (CMDh) for information in the case of Nationally Authorised Products (NAPs). Thereafter, s are expected to take action according to the PRAC recommendations. When appropriate, the PRAC may also recommend the conduct of additional analyses by the Agency or Member States. s are reminded that in line with Article 16(3) of Regulation No (EU) 726/2004 and Article 23(3) of Directive 2001/83/EC, they shall ensure that their product information is kept up to date with the current scientific knowledge including the conclusions of the assessment and recommendations published on the European Medicines Agency (EMA) website (currently acting as the EU medicines webportal). For CAPs, at the time of publication, PRAC recommendations for update of product information have been agreed by the CHMP at their plenary meeting (11-14 September 2017) and corresponding variations will be assessed by the CHMP. For nationally authorised medicinal products, it is the responsibility of the National Competent Authorities (NCAs) of the Member States to oversee that are adhered to. Variations for CAPs are handled according to established EMA procedures. s are referred to the available guidance. Variations for NAPs (including via mutual recognition and decentralised procedures) are handled at national level in accordance with the provisions of the Member States. 1 Please see page 4 for corrections implemented on 6 October 2017 in the pramipexole package leaflet. 2 The relevant EPITT reference number should be used in any communication related to a signal. 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0) Facsimile +44 (0) Send a question via our website An agency of the European Union European Medicines Agency, Reproduction is authorised provided the source is acknowledged.
2 The timeline recommended by PRAC for submission of variations following signal assessment is applicable to both innovator and generic medicinal products, unless otherwise specified. For procedural aspects related to the handling of (e.g. submission requirements, contact points, etc.) please refer to the Questions and Answers on signal management. EMA/PRAC/407007/2017 Page 2/7
3 1. Recommendations for update of the product information Mesalazine Risk of photosensitivity reactions Authorisation procedure Non-centralised EPITT No PRAC rapporteur(s) Patrick Batty (UK) Date of adoption 1 September 2017 Recommendation Having considered the available evidence in EudraVigilance and in the literature, the PRAC has agreed that the (s) of mesalazine-containing medicinal products should submit a variation within 2 months, to amend the product information as described below (new text underlined): Summary of product characteristics 4.8. Undesirable effects Skin and subcutaneous tissue disorders Frequency rare : Photosensitivity* *see section c) Photosensitivity More severe reactions are reported in patients with pre-existing skin conditions such as atopic dermatitis and atopic eczema. Package leaflet 4. Possible side effects Rare side effects Increased sensitivity of your skin to sun and ultraviolet light (photosensitivity). 3 Translations in all official EU languages of the new product information adopted by PRAC are also available to s on the EMA website. EMA/PRAC/407007/2017 Page 3/7
4 1.2. Pramipexole Dystonia Authorisation procedure Centralised and non-centralised EPITT No PRAC rapporteur(s) Doris Irene Stenver (DK) Date of adoption 1 September 2017 Recommendation Having considered the available evidence in EudraVigilance and in the literature, and the known association of pramipexole with axial dystonia, the PRAC has agreed that the s of pramipexolecontaining products should submit a variation within 2 months, to amend the product information as described below (new text underlined): Summary of product characteristics 4.4. Special warnings and precautions for use Dyskinesia [ ] Dystonia Axial dystonia including antecollis, camptocormia and pleurothotonus (Pisa Syndrome) has occasionally been reported in patients with Parkinson s disease following initiation or incremental dose increase of pramipexole. Although dystonia may be a symptom of Parkinson s disease, the symptoms in these patients have improved after reduction or withdrawal of pramipexole. If dystonia occurs, the dopaminergic medication regimen should be reviewed and an adjustment in the dose of pramipexole considered. Package leaflet 2. What you need to know before you take <product name> Warnings and precautions Talk to your doctor before taking <product name>. Tell your doctor if you have (had) or develop any medical conditions or symptoms, especially any of the following: [ ] - Dyskinesia [ ] - Dystonia 4 (inability of keeping your body and neck straight and upright (axial dystonia)). In particular, you may experience forward flexion of the head and neck (also called antecollis), forward bending of the lower back (also called camptocormia) or sidewards bending of the back (also called pleurothotonus or Pisa Syndrome). If this happens, your doctor may want to change your medication. 4 The two bullet points have been merged and brackets have been added after dystonia. EMA/PRAC/407007/2017 Page 4/7
5 2. Recommendations for submission of supplementary information INN Signal (EPITT No) PRAC Action for Azithromycin Increased rate of Kimmo Pfizer relapses of Jaakkola (FI) haematological malignancies and mortality in hematopoietic stem cell transplantation (HSCT) patients (18907) Cefalexin Acute generalized Dolores Eurocept exanthematous Montero International BV pustulosis (AGEP) (ES) (18911) Dexmedetomidine Polyuria (18926) Julie Williams (UK) Assess in currently ongoing PSUSA procedure Orion Corporation Dulaglutide Gastrointestinal Carmela Eli Lilly stenosis and Macchiarulo Nederland B.V. obstruction (18931) (IT) Filgrastim; lenograstim; lipegfilgrastim; pegfilgrastim Aortitis (18940) Overall : Patrick Batty (UK); Individual assessments - filgrastim: Kirsti Villikka (FI); lenograstim: Ghania Chamouni (FR); lipegfilgrastim, pegfilgrastim: Patrick Batty (UK) s of filgrastim, lenograstim, lipegfilgrastim and pegfilgrastim containing products Hydroxycarbamide Cutaneous lupus Laurence de s of erythematosus Fays (BE) hydroxycarbami (18939) de-containing products Ipilimumab Histiocytosis haematophagic (18929) Sabine Straus (NL) Assess in currently ongoing PSUSA procedure (submission by 27 September 2017) Bristol-Myers Squibb Pharma EEIG EMA/PRAC/407007/2017 Page 5/7
6 INN Signal (EPITT No) PRAC Action for Megestrol; vitamin K antagonists (acenocoumarol, fluindione, phenindione, phenprocoumon, warfarin) Drug interaction leading to elevated international normalised ratio (INR)/ haemorrhage with megestrol and vitamin K antagonists (18910) Almath Spooner (IE) Laboratoire Theramex S.A.M.; Sandoz B.V.; Merck Santé S.A.S.; Mercury Pharma Group Ltd; Meda AS; Teofarma S.R.L. Methotrexate Pulmonary alveolar haemorrhage (18850) Martin Huber (DE) Pfizer Pemetrexed Nephrogenic diabetes insipidus (18930) Ghania Chamouni (FR) Eli Lilly Nederland B.V. Rivaroxaban Increased risk of bleeding following drug interaction between rivaroxaban and macrolide antibiotics (18934) Qun-Ying Yue (SE) Assess in the next PSUR (submission by 24 Bayer AG 3. Other recommendations INN Signal (EPITT No) PRAC Action for Amlodipine; rifampicin Drug interaction between amlopdine and rifamipicin leading to reduced antihypertensive effect of amlodipine (18933) Doris Irene Stenver (DK) No action at this stage Not applicable Azithromycin; tobramycin inhaled Possible interaction between tobramycin and azithromycin leading to lower effectiveness of tobramycin (18855) Menno van der Elst (NL) No action at this stage (assess results of TEACH trial when available, ClinicalTrials.gov NCT ) Novartis Europharm Ltd; PARI Pharma GmbH EMA/PRAC/407007/2017 Page 6/7
7 INN Signal (EPITT No) PRAC Action for Doxycycline Doxycycline induced Jarisch-Herxheimer reaction (18937) Martin Huber (DE) Provide comments on proposed updates to the product information (submission by 15 September 2017) Pfizer Meningococcal group B vaccine (rdna, component, adsorbed) Arthritis and synovitis (18764) Qun-Ying Yue (SE) Update RMP Address list of questions in next PSUR (submission by 24 March 2018) GSK Vaccines S.r.l EMA/PRAC/407007/2017 Page 7/7
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08 March 2018 EMA/170163/2018 Human Medicines Evaluation Division Active substance: enalapril / hydrochlorothiazide Procedure no.: PSUSA/00001212/201707 30 Churchill Place Canary Wharf London E14 5EU United
Prasugrel hydrochloride film-coated tablets 5 mg and 10 mg product-specific bioequivalence guidance
31 May 2018 EMA/CHMP/158772/2016/Rev.1 Committee for Medicinal Products for Human Use (CHMP) Prasugrel hydrochloride film-coated tablets 5 mg and 10 mg Draft Agreed by Pharmacokinetics Working Party April
European Medicines Agency decision
EMA/156109/2018 European Medicines Agency decision P/0103/2018 of 19 March 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral for plazomicin (sulfate) (EMEA-001639-PIP02-17)
Reflection paper on the demonstration of a possible impact of maternally derived antibodies on vaccine efficacy in young animals
15 March 2010 EMA/CVMP/IWP/439467/2007 Committee for medicinal products for veterinary use (CVMP) Reflection paper on the demonstration of a possible impact of maternally derived antibodies on vaccine
European Medicines Agency decision
EMA/398442/2016 European Medicines Agency decision P/0191/2016 of 15 July 2016 on the acceptance of a modification of an agreed paediatric investigation plan for agomelatine (Valdoxan, Thymanax), (EMEA-001181-PIP01-11-M03)
Work plan for the joint CHMP/ CVMP Quality Working Party (QWP) for 2018
4 December 2017 EMA/CHMP/CVMP/QWP/504882/2017 Committee for Medicinal Products for Human Use (CHMP) Committee for Medicinal Products for Veterinary Use (CVMP) Work plan for the joint CHMP/ CVMP Quality
Annex I. Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s)
Annex I Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s) Scientific conclusions Taking into account the PRAC Assessment Report on the PSUR(s) for gabapentin,