RIESGO DE BRADICARDIA SEVERA Y BLOQUEO CARDIACO ASOCIADO A LA ADMINISTRACIÓN DE ▼HARVONI®, Y LA COMBINACIÓN DE ▼SOVALDI® MÁS ▼DAKLINZA®, CON AMIODARONA

Se han notificado casos de bradicardia severa y bloqueo cardiaco con la administración de Harvoni® (sofosbuvir y ledipasvir), y la combinación de Sovaldi® (sofosbuvir) y Daklinza® (daclatasvir), en pacientes que se encuentren en tratamiento previo con amiodarona.

En consecuencia, no se recomienda utilizar amiodarona junto con estas combinaciones frente a la hepatitis C, excepto si no es posible el uso de otras alternativas antiarrítmicas. En tal caso, se deberá vigilar estrechamente a los pacientes, especialmente durante las primeras semanas de tratamiento.

POMALIDOMIDA (▼IMNOVID®): RIESGO DE TOXICIDAD HEPÁTICA GRAVE, INSUFICIENCIA CARDIACA Y ENFERMEDAD PULMONAR INTERSTICIAL

(Recomendaciones del Comité para la Evaluación de Riesgos en Farmacovigilancia europeo-PRAC)

En la revisión periódica de los datos de seguridad de pomalidomida, se ha identificado que puede provocar toxicidad hepática grave, enfermedad pulmonar intersticial (EPI) e insuficiencia cardiaca. Por ello, la AEMPS, recomienda:

• Monitorizar periódicamente la función hepática de los pacientes durante los primeros 6 meses de tratamiento con pomalidomida y posteriormente, cuando esté clínicamente indicado.
• En caso de que sea necesario iniciar el tratamiento en pacientes con enfermedad cardiaca preexistente o factores de riesgo, vigilar la evolución del paciente y la posible aparición de insuficiencia cardíaca.
• Descartar EPI en caso de inicio repentino o empeoramiento idiopático de los síntomas pulmonares en pacientes en tratamiento con pomalidomida y suspender el tratamiento hasta el diagnóstico definitivo.

Solicitud del Código Nacional de Parafarmacia

El Laboratorio o Empresa Fabricante, Importador o el Distribuidor, que desee poner en el mercado un producto sanitario podrá solicitar voluntariamente la asignación o revalidación del Código Nacional, al Consejo General de Colegios Oficiales de Farmacéuticos, debiendo a tal efecto, rellenar, firmar y presentar una solicitud:

New treatment for advanced melanoma

24/04/2015

Opdivo offers treatment option for patients with poor prognosis

The European Medicines Agency (EMA) has recommended granting a marketing authorisation for Opdivo (nivolumab). Opdivo is recommended to be used on its own (monotherapy) for the treatment of adult patients with advanced (unresectable or metastatic) melanoma.

Melanoma is the most aggressive type of skin cancer and the leading cause of death from skin disease. The main risk factor for developing melanoma is ultraviolet (UV) light and intermittent exposure to the sun. If melanoma is detected early, it can often be removed by surgery (resected) and has a very good prognosis. However, patients with advanced melanoma have a poor prognosis. It is estimated that five years after the first diagnosis of advanced metastatic melanoma only 10 to 30% of patients will still be alive.

EMA recommends avoidance of certain hepatitis C medicines and amiodarone together

24/04/2015

Concomitant use may increase risk of slow heart rate and related problems

EMA has confirmed a risk of severe bradycardia (slow heart rate) or heart block (problems with conduction of electrical signals in the heart) when the hepatitis C medicines Harvoni (sofosbuvir with ledipasvir) or a combination of Sovaldi (sofosbuvir) and Daklinza (daclatasvir) are used in patients who are also taking the medicine amiodarone, which is an antiarrhythmic (a medicine used to treat irregular heartbeat).

To manage this risk the Agency recommends that amiodarone should only be used in patients taking these hepatitis C medicines if other antiarrhythmics cannot be given. If concomitant use with amiodarone cannot be avoided, patients should be closely monitored. Because amiodarone persists for a long time in the body, monitoring is also needed if patients start such hepatitis C treatments within a few months of stopping amiodarone.

The recommendations follow a review¹ of cases of severe bradycardia or heart block in patients taking amiodarone who started treatment with the hepatitis C combinations. It was considered that there was a likely relationship of these events to the medicines. The possible mechanism behind these effects is unknown and further investigation of other cases with Sovaldi and other hepatitis C medicines is ongoing.

Codeine not to be used in children below 12 years for cough and cold

24/04/2015

Codeine not to be used in children below 12 years for cough and cold

The CMDh¹ has agreed by consensus new measures to minimise the risk of serious side effects, including breathing problems, with codeine-containing medicines when used for cough and cold in children. As a result of these new measures:

• Use of codeine for cough and cold is now contraindicated in children below 12 years. This means it must not be used in this patient group.
• Use of codeine for cough and cold is not recommended in children and adolescents between 12 and 18 years who have breathing problems.

First EU treatment for rare sleep-wake disorder

24/04/2015

Hetlioz to help regulate sleep patterns in blind people

The European Medicines Agency (EMA) has recommended granting a marketing authorisation for Hetlioz (tasimelteon) to treat non-24-hour sleep-wake disorder in totally blind adults. There is currently no approved treatment for this condition in the European Union (EU).

Non-24-hour sleep-wake disorder occurs almost exclusively in people who are completely blind. How the body adjusts to the 24-hour clock is closely linked to the pattern of daylight, and so people who do not perceive light are more likely to suffer from the disorder. They fall asleep and wake up at different times compared with the general population, often in a pattern that is closer to a 25-hour clock. As a result, they have problems adjusting to the standard timetable of everyday life, often being awake or asleep at unusual times.

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 April 2015

24/04/2015

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 April 2015

Eleven new medicines, including one orphan, recommended for approval

Eleven new medicines were recommended for approval at the April 2015 meeting of theCommittee for Medicinal Products for Human Use (CHMP).

The CHMP recommended granting a marketing authorisation for Opdivo (nivolumab), for the treatment of adults with advanced (unresectable or metastatic) melanoma. For more information on Opdivo, please see the press release in the grid below.

The Committee recommended granting a marketing authorisation for Hetlioz(tasimelteon) to treat non-24-hour sleep-wake disorder in totally blind adults. Hetlioz was granted orphan designation in 2011. For more information on Hetlioz, please see the press release in the grid below.

Scientific advice leads to stronger applications from industry

17/04/2015

Adherence to EMA scientific advice on trial design results in higher success rates, shorter overall assessment time and fewer major objections during assessment

The majority of clinical development plans submitted for scientific advice to the European Medicines Agency (EMA) prior to a marketing authorisation application were found not suitable for future benefit-risk assessment. Companies that changed their clinical development plans in accordance with the recommendation from EMA were more likely to be granted a marketing authorisation.

These are the main findings of an analysis of marketing authorisation application outcomes between 2008 and 2012 conducted by staff members of EMA and itsScientific Advice Working Party (SAWP) and published in Nature Reviews Drug Discovery.

EMA, through its SAWP, provides scientific advice to companies during the development of their medicines to help them design trials that are scientifically sound and generate adequate data for the benefit-risk assessment by EMA’s Committee for Medicinal Products for Human Use (CHMP).

Scientific advice is the Agency’s key instrument to support the development of high-quality, effective and safe medicines that meet the needs of patients. By providing scientific advice to developers of medicines, EMA also protects patients from participating in clinical trials that are unlikely to lead to the approval of new medicines.

Concept paper on the development of a guideline on quality and equivalence of topical products

In recent years, the assessment of topical products has evolved. It has become evident that their quality needs to be thoroughly understood and characterised, supported by a robust manufacturing process and control strategy. In addition, the designated shelf life needs to be based not only on physical, chemical and microbiological stability, but also, when necessary, on evidence of stable in vitro performance to assure equivalence throughout storage.

Reference number: EMA/CHMP/QWP/558185/2014

Status. draft: consultation open

First published: 22/04/2015

Last updated: 22/04/2015

Consultation start date: 22/04/2015

Consultation end date: 22/07/2015

See the document

Regulatory information – application deadline for participation in information-sharing pilot project for generics extended

21/04/2015

Companies encouraged to submit expressions of interest

The deadline for submitting expressions of interest to participate in the information-sharing initiative for generics has been extended to give more time to companies to submit their applications.

The European Medicines Agency (EMA) launched this initiative in January 2015 for centrally approved products, as part of the International Generic Drug Regulators Pilot (IGDRP) programme. The pilot allows EMA to share its assessments of applications for generic medicines in real time with collaborating regulatory agencies outside the European Union (EU).

Companies are invited to express their interest in participating in the pilot programme using the form provided. The expression of interest should be submitted at least eight weeks in advance of the submission of the related centralised application.

About IGDRP

The IGDRP was launched in April 2012 to strengthen collaboration and convergence between regulatory agencies worldwide and mitigate challenges of global generic development and approval programmes.

This information-sharing initiative is one of the work packages of the IGDRP. It aims to facilitate the timely authorisation and availability of safe, effective and high quality generic medicines worldwide. 

Revipharm: Regulatory information – EMA provides advice notes on pharmacovigilance annual fees

See:

Questions & Answers (Q&As)

EMA fees query form

Regulatory information – EMA provides advice notes on pharmacovigilance annual fees

20/04/2015

Marketing-authorisation holders are advised to liaise with their qualified persons for pharmacovigilance prior to invoicing in July 2015

The European Medicines Agency (EMA) has provided ‘advice notes’ on pharmacovigilance annual fees to the qualified persons for pharmacovigilance.

From 1 July 2015, EMA will charge and collect annual fees for pharmacovigilanceactivities for nationally authorised medicines.

Representante Autorizado (EC REP, European Authorized Representative)

La Directiva 93/42/CEE de productos sanitarios establece para todos los fabricantes de productos sanitarios  (activos e in vitro incluidos) establecidos fuera de la UE la obligatoriedad de contar con un Representante Autorizado, con las siguientes funciones: 

Risk minimisation strategy for high strength and fixed combination insulin products, addendum to the good practice guide on risk minimisation and prevention of medication errors

The guidance provides a strategy to minimise the potential risk of medication errors associated with the introduction of high strength insulins (i.e. higher than the EU-wide standard of 100 units/ml concentration) and fixed combinations of insulin with another non-insulin injectable blood glucose lowering agent.

Consultation start date: 14/04/2015

Consultation end date: 14/06/2015

Posted on the EMA website on 14 April 2015

Revipharm: Preventing medication errors in the European Union

Revipharm: Preventing medication errors in the European Union

Related documents:

• Good practice guide on risk minimisation and prevention of medication errors
• Good practice guide on recording, coding, reporting and assessment of medication errors

Preventing medication errors in the European Union

EMA invites comments on draft good practice guides

Posted on the EMA website on 14April 2015

The European Medicines Agency (EMA), on behalf of the European Union (EU) Regulatory Network, has released two draft good practice guides that aim to improve the reporting, evaluation and prevention of medication errors by regulatory authorities and pharmaceutical industry throughout the EU. The deadline for stakeholders to send their comments to EMA is 14 June 2015.

Medication errors are unintended mistakes in the prescribing, dispensing and administration of a medicine that could cause harm to a patient. They are the most common preventable cause of undesired harmful effects (adverse events) in medication practice and present a major public health burden.

With the entry into force of the EU pharmacovigilance legislation in 2012, reporting of all suspected adverse reactions resulting from medication errors became mandatory. Pharmaceutical companies and national regulatory agencies in the EU Members States are obliged to enter these adverse events in EudraVigilance, the EU adverse reaction collection and management system. The primary purpose of the two guides released today is to support industry and regulators in the implementation of these legal requirements.

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 April 2015

PRAC recommends updating advice on use of high‑dose ibuprofen

The PRAC has completed a review confirming a small increase in the risk of cardiovascular problems, such as heart attacks and strokes, in patients taking high doses of ibuprofen (at or above 2,400 mg per day). No increase in cardiovascular risk is seen with ibuprofen at doses up to 1,200 mg per day, which is the highest dose generally used for over-the-counter (OTC) preparations taken by mouth in the European Union (EU).

The PRAC recommended updating the advice in the product information of ibuprofen medicines. The recommendations for ibuprofen also apply to dexibuprofen, a medicine similar to ibuprofen. A high dose of dexibuprofen is a dose at or above 1,200 mg per day.

PRAC recommends further measures to minimise known risk of osteonecrosis of the jaw associated with zoledronic acid-containing medicines and denosumab

The PRAC has conducted three periodic reviews of denosumab (Prolia, Xgeva) and the bisphosphonate medicine zoledronic acid (Zometa, Zoledronic acid medac, and other nationally authorised medicines). Osteonecrosis of the jaw is a known risk for these medicines. The PRAC recommended measures, including updates to the product information and the introduction of patient reminder cards, to further minimise the known risks.

These reviews, known as a periodic safety update single assessment (PSUSA), are part of the regular safety monitoring of medicines. These recommendations follow a similar recommendation for another bisphosphonate medicine containing zoledronic acid(Aclasta) in March 2015.  The PRAC will also consider similar measures for other intravenous bisphosphonates used for osteoporosis or for preventing bone complications of cancers. The measures will be considered during the upcoming and ongoing periodic reviews for these medicines, which are planned to take place over the course of 2015/2016.

Posted on the EMA website on 13 April 2015

PRAC recommends updating advice on use of high dose ibuprofen

Review confirms small increased cardiovascular risk with daily doses at or above 2,400 mg

European Medicines Agency’s (EMA's) Pharmacovigilance Risk Assessment Committee(PRAC) has completed a review confirming a small increase in the risk of cardiovascular problems, such as heart attacks and strokes, in patients taking high doses of ibuprofen (at or above 2,400 mg per day). The review clarifies that the risk with high-dose ibuprofen is similar to the risk seen with some other non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors and diclofenac.

No increase in cardiovascular risk is seen with ibuprofen at doses up to 1,200 mg per day, which is the highest dose generally used for over-the-counter (OTC) preparations taken by mouth in the European Union (EU).

The PRAC concluded that the benefits of ibuprofen outweigh the risks but recommended updating advice on the use of high-dose ibuprofen to minimise the cardiovascular risk. High doses of ibuprofen (2,400 mg per day or higher) should be avoided in patients with serious underlying heart or circulatory conditions, such as heart failure, heart disease and circulatory problems or in those who have previously had a heart attack or stroke.

FREE SALES CERTIFICATES

Certificate of Free Sales (or Certificate of Marketability) is a document verifying that the specified imported product is freely sold in the exporting country’s market and as such is approved for export.

Please note however that Revipharm has to be designated as your Responsible person in order to be able to apply for the FSC at the competent authorities on your behalf.

RIESGO CARDIOVASCULAR DE DOSIS ALTAS DE IBUPROFENO O DEXIBUPROFENO: RECOMENDACIONES DE USO

RIESGO CARDIOVASCULAR DE DOSIS ALTAS DE IBUPROFENO O DEXIBUPROFENO: RECOMENDACIONES DE USO

(Recomendaciones del Comité para la Evaluación de Riesgos en Farmacovigilancia europeo-PRAC)

Fecha de publicación: 13 de abril de 2015

Referencia: MUH (FV), 4/2015

Tras la revisión europea que se ha realizado acerca del riesgo cardiovascular de ibuprofeno y dexibuprofeno, la AEMPS recomienda a los profesionales sanitarios:

• No administrar dosis altas de ibuprofeno o dexibuprofeno a pacientes con patología cardiovascular grave como insuficiencia cardiaca (clasificación II-IV de New York Heart Association-NYHA), cardiopatía isquémica establecida, enfermedad arterial periférica o enfermedad cerebrovascular.
• Antes de iniciar tratamiento a largo plazo con ibuprofeno o dexibuprofeno, sobre todo si se requieren dosis altas, se deberán evaluar cuidadosamente los factores de riesgo cardiovascular asociados del paciente.

Ibuprofeno⁽¹⁾ es un antiinflamatorio no esteroideo (AINE) autorizado para el tratamiento de procesos dolorosos de intensidad leve y moderada, tratamiento de la fiebre y el tratamiento sintomático de procesos reumáticos e inflamatorios. Actúa mediante la inhibición no selectiva de la ciclooxigenasa (COX), reduciendo la síntesis de prostaglandinas. Dexibuprofeno⁽¹⁾ es el enantiómero activo de ibuprofeno y sus usos son equiparables, aunque ambos no son equipotentes.

Importación de cosméticos y productos de higiene personal

La empresa o persona física que quiera importar productos cosméticos y productos de higiene personal, debe presentar a la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) una declaración responsable de inicio de actividad:

Questions and answers on 'Guideline on the environmental risk assessment of medicinal products for human use'

Status: draft (consultation open)
Consultation start date: 31/03/2015
Consultation end date: 30/06/2015

The aim of the current question-and-answer document is to provide clarification and to harmonise the use of the 'Guideline on the environmental risk assessment of medicinal products for human use' (EMEA/CHMP/SWP/4447/00).

Posted on the EMA website on 31 March 2015