Cilostazol-containing medicines

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European Medicines Agency recommends restricting use of cilostazol-containing medicines

On 22 March 2013, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended that the use of cilostazol-containing medicines in the treatment of intermittent claudication – a condition where poor blood supply to the leg muscles causes pain and affects the ability to walk – should be restricted with a range of new measures aimed at targeting a patient population in which there are clinical benefits, and at the same time minimising important risks.

The recommendations followed a review of current evidence, which indicated that the modest benefits of these medicines, i.e. their ability to increase the distance patients are able to walk, are only greater than their risks, in particular the risks of side effects affecting the heart or serious bleeding, in a limited subgroup of patients.

Cilostazol-containing medicines are available in the European Union (EU) under the names Pletal and Ekistol.

The Committee recommended that cilostazol should only be used in patients whose symptoms have not improved despite prior lifestyle changes such as exercise, healthy diet and stopping smoking. In addition, cilostazol-containing medicines should not be used in patients who have suffered severe tachyarrhythmia (fast, abnormal heart rhythm), or recent unstable angina, heart attack or bypass surgery, or who take two or more antiplatelet or anticoagulant medicines such as aspirin and clopidogrel.

Doctors should review their patients at their next routine appointment and assess the continued suitability of cilostazol treatment.

Detailed recommendations for patients and healthcare professionals are available below.

The Spanish Agency for Medicines and Health Products (AEMPS) asked the CHMP to carry out a review of these medicines following a number of reports of serious suspected side effects, in particular affecting the heart, as well as cases of serious bleeding.

The CHMP examined available clinical-trial data on the benefits and risks of the medicines provided by the companies that market these medicines, as well as data from scientific literature, reports of suspected side effects, post-marketing studies and experimental studies before making its recommendations. More information on the studies and the CHMP’s conclusions is available below.

The CHMP recommendation was sent to the European Commission, which endorsed it and adopted a legally-binding decision throughout the EU on 24 June 2013.

Information to patients
  • Cilostazol is used to treat intermittent claudication, a condition where walking becomes painful and difficult because of problems with blood circulation in the arteries of the legs. Cilostazol-containing medicines are available in the EU under the names Pletal and Ekistol.
  • The Agency has recommended some restrictions on the use of cilostazol. If you are taking cilostazol-containing medicines, you should make a non-urgent appointment with your doctor to review your treatment.
  • Your doctor will advise you whether you should continue taking cilostazol, stop taking cilostazol, or change the dose that you are taking. The advice will vary for each patient depending on factors such as lifestyle options that could improve your condition, whether your walking symptoms have improved since you started cilostazol, whether you have had recent heart problems, and which other medicines you are taking.
  • If you have any questions, you should contact your doctor or pharmacist.
Information to healthcare professionals

Healthcare professionals should follow these recommendations:

  • Cilostazol should only be used for intermittent claudication when lifestyle changes (including smoking cessation and exercise programmes) and other appropriate interventions alone have not produced adequate benefit.
  • Treatment should only be started by physicians experienced in the management of intermittent claudication, and should be reviewed after three months. Treatment should be stopped in patients who have not shown clinically relevant benefit.
  • Cilostazol should not be given to patients who have unstable angina or who have had myocardial infarction or a coronary intervention (PCI) within the last six months, nor to those with a history of severe tachyarrhythmia.
  • Cilostazol should also not be given to patients also receiving both aspirin and clopidogrel, or any other combination of two or more additional antiplatelet or anticoagulant medicines.
  • Prescribers should be aware of the risk of interactions with cilostazol; its dose should be reduced in patients also taking strong inhibitors of CYP3A4 or CYP2C19.
  • Other healthcare professionals should refer patients to the prescribing physician as appropriate.

For the full changes to information for doctors and patients, see under the ‘all documents’ tab.

More information on the assessment

The Agency’s recommendations are based on a review by the Committee for Medicinal Products for Human Use (CHMP), which looked at available data on the benefits and risks of cilostazol.

  • Cilostazol has been shown to produce modest increases in walking distance compared with placebo. Meta-analysis of pooled individual patient data from nine efficacy trials involving 3,122 patients indicated a mean percentage increase from baseline of 59.4% for cilostazol, compared with 24.3% for placebo. This corresponded to an absolute increase in walking distance of 87.4 metres and 43.7 metres respectively (from a baseline of about 133 metres). CHMP concluded that the magnitude of benefit was clinically important in a subgroup of patients, and that response can be adequately assessed after three months of treatment.
  • Safety data from nearly 14,000 suspected adverse-drug-reaction reports (in the context of over 6 million patient-years’ exposure worldwide) and 4,000 events in noninterventional studies confirmed the known adverse effect profile of cilostazol from clinical trials. Cases of haemorrhage represented about 8% of the spontaneous reports. The most common cardiovascular events reported were palpitations and tachycardia (each about 5% of total spontaneous reports).
  • Long-term cardiovascular safety of cilostazol was examined post-marketing in the CASTLE study1, a randomised double-blind placebo controlled study involving 1,439 patients given cilostazol 100 mg twice daily (reduced to 50 mg twice daily if necessary) or placebo. The trial, which examined all-cause mortality as a primary endpoint, was terminated early (after about 3 years) because of a high drop-out rate in both groups (397 out of 721 cilostazol patients and 391 out of 718 patients taking placebo) and because of a much lower mortality rate than expected. There were 49 deaths in the cilostazol group, of which 12 were due to cardiac disorders, and 52 in the placebo group (13 cardiac). When a composite endpoint of cardiac morbidity (coronary and cerebrovascular events) and mortality was considered, there were 135 events with cilostazol and 153 with placebo. Although the design and early termination of the study limit the conclusions that can be drawn, these results provide some reassurance with regard to cardiovascular safety of cilostazol.
  • Analysis of available data suggests an increased risk of haemorrhage when cilostazol is given to patients also taking both aspirin and clopidogrel. However the evidence suggests that cilostazol alone, or in combination with one other antiplatelet drug, does not increase the risk of bleeding.

In conclusion, the CHMP considered that, although on average the efficacy of cilostazol is modest, there is a small group of patients in whom it is of clinical relevance, not least in helping them to begin exercise programmes. Although suspected adverse-drug-reaction reports have raised some safety concerns, these have not been substantiated in the clinical trial data (including the CASTLE study), and it remains possible to exclude high-risk patients in clinical practice. CHMP therefore recommended a number of measures aimed at targeting use of cilostazol to the population most likely to benefit, and in whom the risk of side effects is low.

Reference

1Hiatt WR, Money SR, Brass EP. Long-term safety of cilostazol in patients with peripheral artery disease: the CASTLE study (Cilostazol: A Study in Long-term Effects). J Vasc Surg 2008; 47: 330-336.

More about the medicine

Cilostazol is a medicine that is used to improve walking distance in patients who have intermittent claudication due to peripheral arterial obstructive disease (obstruction and narrowing of the arteries of the limbs, leading to reduced blood flow).

Medicines containing cilostazol have been approved in the EU through national procedures since 2000 and are available in France, Germany, Italy, Spain, Sweden and the United Kingdom under the invented names Pletal and Ekistol.

Cilostazol works by blocking an enzyme called phosphodiesterase type 3, which is found in the walls of arteries and is involved in various processes affecting circulation, including aggregation (clumping together) of blood platelets and narrowing of the arteries. Blocking the enzyme reduces these actions and blood flow is improved, allowing patients to walk further without disabling pain.

More about the procedure

The review of cilostazol was initiated at the request of Spain, under Article 31 of Directive 2001/83/EC.

The Spanish Agency for Medicines and Health Products (AEMPS) asked the CHMP to carry out a full assessment of the benefit-risk balance of cilostazol and to issue an opinion on whether the marketing authorisations for products containing cilostazol should be maintained, varied, suspended or withdrawn across the EU.

The request followed reports to the Spanish agency of serious adverse effects affecting the heart including fatal heart attacks, angina and arrhythmias (irregular heartbeat) as well as cases of serious bleeding including bleeding in the brain. Many of the patients who were prescribed the medicine were much older, and taking more medicines, than those in whom it was originally tested before marketing, which may explain the increased risk of side effects. There was evidence that many of these patients had to stop taking the medicine. In addition, the benefits of treatment were modest.

The CHMP opinion was forwarded to the European Commission, which issued a final decision endorsing the opinion on 24 June 2013.

Name Language First published Last updated
Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines BG = bălgarski 2013-09-11  
Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines ES = español 2013-09-11  
Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines CS = čeština 2013-09-11  
Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines DA = dansk 2013-09-11  
Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines DE = Deutsch 2013-09-11  
Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines ET = eesti keel 2013-09-11  
Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines EL = elliniká 2013-09-11  
Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines EN = English 2013-09-11  
Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines FR = français 2013-09-11  
Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines IT = italiano 2013-09-11  
Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines LV = latviešu valoda 2013-09-11  
Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines LT = lietuvių kalba 2013-09-11  
Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines HU = magyar 2013-09-11  
Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines MT = Malti 2013-09-11  
Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines NL = Nederlands 2013-09-11  
Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines PL = polski 2013-09-11  
Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines PT = português 2013-09-11  
Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines RO = română 2013-09-11  
Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines SK = slovenčina 2013-09-11  
Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines SL = slovenščina 2013-09-11  
Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines FI = suomi 2013-09-11  
Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines SV = svenska 2013-09-11  
Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines HR = Hrvatski 2013-09-11  

Key facts

Approved nameCilostazol-containing medicines
International non-proprietary name (INN) or common name

cilostazol

Associated namesPletal, Ekistol
Classantiplatelet agents
Reference numberEMEA/H/A-31/1306
TypeArticle 31 referrals

This type of referral is triggered when the interest of the Community is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

StatusEuropean Commission final decision
Opinion date21/03/2013

All documents

Name Language First published Last updated
Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines BG = bălgarski 2013-09-11  
Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines ES = español 2013-09-11  
Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines CS = čeština 2013-09-11  
Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines DA = dansk 2013-09-11  
Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines DE = Deutsch 2013-09-11  
Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines ET = eesti keel 2013-09-11  
Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines EL = elliniká 2013-09-11  
Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines EN = English 2013-09-11  
Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines FR = français 2013-09-11  
Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines IT = italiano 2013-09-11  
Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines LV = latviešu valoda 2013-09-11  
Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines LT = lietuvių kalba 2013-09-11  
Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines HU = magyar 2013-09-11  
Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines MT = Malti 2013-09-11  
Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines NL = Nederlands 2013-09-11  
Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines PL = polski 2013-09-11  
Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines PT = português 2013-09-11  
Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines RO = română 2013-09-11  
Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines SK = slovenčina 2013-09-11  
Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines SL = slovenščina 2013-09-11  
Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines FI = suomi 2013-09-11  
Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines SV = svenska 2013-09-11  
Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines HR = Hrvatski 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex I (cilostazol) BG = bălgarski 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex I (cilostazol) ES = español 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex I (cilostazol) CS = čeština 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex I (cilostazol) DA = dansk 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex I (cilostazol) DE = Deutsch 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex I (cilostazol) ET = eesti keel 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex I (cilostazol) EL = elliniká 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex I (cilostazol) EN = English 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex I (cilostazol) FR = français 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex I (cilostazol) IT = italiano 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex I (cilostazol) LV = latviešu valoda 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex I (cilostazol) LT = lietuvių kalba 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex I (cilostazol) HU = magyar 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex I (cilostazol) MT = Malti 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex I (cilostazol) NL = Nederlands 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex I (cilostazol) PL = polski 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex I (cilostazol) PT = português 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex I (cilostazol) RO = română 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex I (cilostazol) SK = slovenčina 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex I (cilostazol) SL = slovenščina 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex I (cilostazol) FI = suomi 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex I (cilostazol) SV = svenska 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex II (cilostazol) BG = bălgarski 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex II (cilostazol) ES = español 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex II (cilostazol) CS = čeština 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex II (cilostazol) DA = dansk 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex II (cilostazol) DE = Deutsch 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex II (cilostazol) ET = eesti keel 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex II (cilostazol) EL = elliniká 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex II (cilostazol) EN = English 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex II (cilostazol) FR = français 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex II (cilostazol) IT = italiano 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex II (cilostazol) LV = latviešu valoda 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex II (cilostazol) LT = lietuvių kalba 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex II (cilostazol) HU = magyar 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex II (cilostazol) MT = Malti 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex II (cilostazol) NL = Nederlands 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex II (cilostazol) PL = polski 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex II (cilostazol) PT = português 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex II (cilostazol) RO = română 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex II (cilostazol) SK = slovenčina 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex II (cilostazol) SL = slovenščina 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex II (cilostazol) FI = suomi 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex II (cilostazol) SV = svenska 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex III (cilostazol) BG = bălgarski 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex III (cilostazol) ES = español 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex III (cilostazol) CS = čeština 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex III (cilostazol) DA = dansk 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex III (cilostazol) DE = Deutsch 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex III (cilostazol) ET = eesti keel 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex III (cilostazol) EL = elliniká 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex III (cilostazol) EN = English 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex III (cilostazol) FR = français 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex III (cilostazol) IT = italiano 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex III (cilostazol) LV = latviešu valoda 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex III (cilostazol) LT = lietuvių kalba 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex III (cilostazol) HU = magyar 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex III (cilostazol) MT = Malti 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex III (cilostazol) NL = Nederlands 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex III (cilostazol) PL = polski 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex III (cilostazol) PT = português 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex III (cilostazol) RO = română 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex III (cilostazol) SK = slovenčina 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex III (cilostazol) SL = slovenščina 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex III (cilostazol) FI = suomi 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex III (cilostazol) SV = svenska 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex IV (cilostazol) BG = bălgarski 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex IV (cilostazol) ES = español 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex IV (cilostazol) CS = čeština 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex IV (cilostazol) DA = dansk 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex IV (cilostazol) DE = Deutsch 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex IV (cilostazol) ET = eesti keel 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex IV (cilostazol) EL = elliniká 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex IV (cilostazol) EN = English 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex IV (cilostazol) FR = français 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex IV (cilostazol) IT = italiano 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex IV (cilostazol) LV = latviešu valoda 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex IV (cilostazol) LT = lietuvių kalba 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex IV (cilostazol) HU = magyar 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex IV (cilostazol) MT = Malti 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex IV (cilostazol) NL = Nederlands 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex IV (cilostazol) PL = polski 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex IV (cilostazol) PT = português 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex IV (cilostazol) RO = română 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex IV (cilostazol) SK = slovenčina 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex IV (cilostazol) SL = slovenščina 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex IV (cilostazol) FI = suomi 2013-09-11  
Cilostazol-containing medicines - Article-31 referral - Annex IV (cilostazol) SV = svenska 2013-09-11  
Assessment report for cilostazol-containing medicinal products (English only) 2013-09-11  
European Medicines Agency recommends restricting use of cilostazol-containing medicines (English only) 2013-03-22  
Cilostazol - Article-31 referral - Product information as approved by the CHMP on 21 March 2013, pending endorsement by the European Commission (English only) 2013-03-22  

Document description

  • Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
  • Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents are sometimes available:

  • Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes have been recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies

Current status:
European Commission final decision

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