Adrenaline auto-injectors

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On 25 June 2015, the European Medicines Agency (EMA) recommended several measures, including the introduction of more effective educational material, to ensure that patients and carers use adrenaline auto-injectors successfully. Adrenaline auto-injectors are potentially life-saving treatments for anaphylaxis (severe allergic reactions) while the patient waits for emergency medical assistance.

EMA carried out a review of adrenaline auto-injectors following concerns that currently available devices may deliver adrenaline under the skin instead of into a muscle, and this may delay response to treatment.

Having assessed all the available data, EMA’s Committee for Medicinal Products for Human Use (CHMP) acknowledged that giving the medicine by injection into the muscle is the preferred way to obtain a rapid response in anaphylaxis. However, the CHMP noted that several factors may affect whether adrenaline is actually delivered into a muscle; these include needle length, the thickness of fat under the skin, the way the auto-injector works (e.g. if it is spring loaded or not), the angle at which the device is placed on the skin and the force used to activate the device as well as how well the user follows the instructions for injection.

The CHMP concluded that training of the user is of paramount importance. The companies that market adrenaline auto-injectors have therefore been asked to develop more effective educational material for patients, as well as for healthcare professionals, to ensure their optimal use. This includes a training device with which patients can practise; audio-visual material to show in detail how the device is to be used; and a checklist for prescribers to ensure that sufficient information is given to the patient before they use the auto-injector. The product information of adrenaline auto-injectors has also been updated with further warnings and precautions, including a recommendation that patients should be prescribed two auto-injectors which they should carry at all times and a recommendation for family members, carers or teachers to be trained on how to use the auto-injector.

The CHMP also concluded that further data should be generated to better understand how adrenaline penetrates body tissues when given with each of the different auto-injectors.

The CHMP recommendation was sent to the European Commission which endorsed it and issued a legally binding decision that is valid throughout the EU.

Information for patients
  • Adrenaline auto-injectors are used to treat severe allergic reactions, while the patient awaits emergency medical assistance. They are designed so that they can be easily used by the patient themselves or a carer.
  • The review of adrenaline auto-injectors showed that patients could benefit from further training to use the auto-injector successfully.
  • You will receive training from your doctor or nurse on how to use your adrenaline auto-injector. A training device will also be developed so that you can practise with it before you need the auto-injector in an emergency. A training video will be produced to show you in detail how to use the injector properly.
  • It is important that you use the auto-injector correctly so that the adrenaline is delivered into your muscle and works as quickly as possible.
  • If you have been prescribed an adrenaline auto‑injector because you are at risk of severe allergic reactions, you should ensure you are familiar with it and carry it with you at all times.
  • It is likely that your doctor will recommend that you carry 2 injectors, in case a second dose is needed while you wait for emergency assistance.
  • Your family members, carers or teachers should also be instructed in the correct use of the auto-injector.
  • If you have any question or concern, speak with your doctor or pharmacist.
Information for healthcare professionals
  • The review of adrenaline auto-injectors confirmed that intramuscular injection is the preferred route of administration in the treatment of anaphylaxis in order to obtain a rapid response.
  • Several factors may affect whether adrenaline reaches the muscle layer. These include: needle length, the skin-to-muscle depth, the way the auto-injector works (e.g. if it is spring loaded or not), the angle of placement on the skin and the force used to activate the device.
  • Because of the uncertainties over drug delivery from adrenaline auto-injectors and the consequent uncertainties around the onset of pharmacodynamic response, it is recommended that healthcare professionals prescribe 2 auto-injectors, which patients should carry at all times.
  • Educational material will be developed to ensure that patients or carers use adrenaline auto-injectors successfully. This will include a training device that patients can practise with, audio-visual material and a prescriber checklist.
  • A study in 2013 by Brown et al. showed that 15% of the mothers were unable to use the auto-injector successfully in their children. This supports the introduction of proper training and comprehensive educational material for patients and healthcare professionals.
  • The companies that market adrenaline auto-injectors have been asked to carry out a pharmacokinetic/pharmacodynamic study to better understand how adrenaline penetrates body tissues when given through an auto-injector.
References

The review looked at data from several studies including:

  • Bhalla, M. C., B. D. Gable, et al. (2013). "Predictors of epinephrine autoinjector needle length inadequacy." Am J Emerg Med 31(12): 1671-1676.
  • Brown, J., D. Tuthill, et al. (2013). "A randomized maternal evaluation of epinephrine autoinjection devices." Pediatr Allergy Immunol 24(2): 173-177.
  • Simons, F. E., X. Gu, et al. (2001). "Epinephrine absorption in adults: intramuscular versus subcutaneous injection." J Allergy Clin Immunol 108(5): 871-873.
  • Simons, F. E., J. R. Roberts, et al. (1998). "Epinephrine absorption in children with a history of anaphylaxis." J Allergy Clin Immunol 101(1 Pt 1): 33-37.
  • Song, T. T., M. R. Nelson, et al. (2005). "Adequacy of the epinephrine autoinjector needle length in delivering epinephrine to the intramuscular tissues." Ann Allergy Asthma Immunol 94(5): 539-542.
  • Stecher, D., B. Bulloch, et al. (2009). "Epinephrine auto-injectors: is needle length adequate for delivery of epinephrine intramuscularly?" Pediatrics 124(1): 65-70.
  • Wang, C., R. Wolf, et al. (2013). Comparison of Needle Penetration Depth Probabilities of Two Epinephrine Auto-Injectors. ALLERGY AND ASTHMA PROCEEDINGS, OCEAN SIDE PUBLICATIONS INC 95 PITMAN ST, PROVIDENCE, RI 02906 USA.
More about the medicine

Adrenaline (epinephrine) auto-injectors are given to people who are at risk of anaphylaxis (severe allergic reaction) or have had a previous episode of anaphylaxis, to use as a first‑aid measure in case of emergencies while waiting for emergency medical assistance.

Anaphylaxis is a life-threatening reaction that causes a drop in blood pressure and breathing difficulties. An injection of adrenaline helps to relieve the symptoms of anaphylaxis quickly by narrowing the blood vessels (thereby increasing the blood pressure) and opening up the airways to help with the breathing.

Adrenaline auto-injectors have been approved through national procedures in all the EU Member States.

More about the procedure

The review of adrenaline auto-injectors was initiated at the request of the United Kingdom in April 2014, under Article 31 of Directive 2001/83/EC. This followed a national review of all adrenaline auto-injector products approved in the UK, which concluded that there was no robust evidence that the devices deliver adrenaline into a muscle for all patients.

The review was carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which has adopted the Agency’s final opinion. The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 14/08/2015.

Name Language First published Last updated
Adrenaline auto-injectors Article-31 referral - Better training tools recommended to support patients using adrenaline auto-injectors BG = bălgarski 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Better training tools recommended to support patients using adrenaline auto-injectors ES = español 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Better training tools recommended to support patients using adrenaline auto-injectors CS = čeština 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Better training tools recommended to support patients using adrenaline auto-injectors DA = dansk 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Better training tools recommended to support patients using adrenaline auto-injectors DE = Deutsch 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Better training tools recommended to support patients using adrenaline auto-injectors ET = eesti keel 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Better training tools recommended to support patients using adrenaline auto-injectors EL = elliniká 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Better training tools recommended to support patients using adrenaline auto-injectors EN = English 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Better training tools recommended to support patients using adrenaline auto-injectors FR = français 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Better training tools recommended to support patients using adrenaline auto-injectors IT = italiano 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Better training tools recommended to support patients using adrenaline auto-injectors LV = latviešu valoda 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Better training tools recommended to support patients using adrenaline auto-injectors LT = lietuvių kalba 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Better training tools recommended to support patients using adrenaline auto-injectors HU = magyar 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Better training tools recommended to support patients using adrenaline auto-injectors MT = Malti 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Better training tools recommended to support patients using adrenaline auto-injectors NL = Nederlands 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Better training tools recommended to support patients using adrenaline auto-injectors PL = polski 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Better training tools recommended to support patients using adrenaline auto-injectors PT = português 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Better training tools recommended to support patients using adrenaline auto-injectors RO = română 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Better training tools recommended to support patients using adrenaline auto-injectors SK = slovenčina 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Better training tools recommended to support patients using adrenaline auto-injectors SL = slovenščina 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Better training tools recommended to support patients using adrenaline auto-injectors FI = suomi 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Better training tools recommended to support patients using adrenaline auto-injectors SV = svenska 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Better training tools recommended to support patients using adrenaline auto-injectors HR = Hrvatski 2015-06-26 2015-08-26

Key facts

Approved nameAdrenaline auto-injectors
International non-proprietary name (INN) or common name

adrenaline (epinephrine)

Associated names
Class
Reference numberEMEA/H/A-31/1398
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 date25/06/2015

All documents

Name Language First published Last updated
Adrenaline auto-injectors Article-31 referral - Better training tools recommended to support patients using adrenaline auto-injectors BG = bălgarski 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Better training tools recommended to support patients using adrenaline auto-injectors ES = español 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Better training tools recommended to support patients using adrenaline auto-injectors CS = čeština 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Better training tools recommended to support patients using adrenaline auto-injectors DA = dansk 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Better training tools recommended to support patients using adrenaline auto-injectors DE = Deutsch 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Better training tools recommended to support patients using adrenaline auto-injectors ET = eesti keel 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Better training tools recommended to support patients using adrenaline auto-injectors EL = elliniká 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Better training tools recommended to support patients using adrenaline auto-injectors EN = English 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Better training tools recommended to support patients using adrenaline auto-injectors FR = français 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Better training tools recommended to support patients using adrenaline auto-injectors IT = italiano 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Better training tools recommended to support patients using adrenaline auto-injectors LV = latviešu valoda 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Better training tools recommended to support patients using adrenaline auto-injectors LT = lietuvių kalba 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Better training tools recommended to support patients using adrenaline auto-injectors HU = magyar 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Better training tools recommended to support patients using adrenaline auto-injectors MT = Malti 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Better training tools recommended to support patients using adrenaline auto-injectors NL = Nederlands 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Better training tools recommended to support patients using adrenaline auto-injectors PL = polski 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Better training tools recommended to support patients using adrenaline auto-injectors PT = português 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Better training tools recommended to support patients using adrenaline auto-injectors RO = română 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Better training tools recommended to support patients using adrenaline auto-injectors SK = slovenčina 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Better training tools recommended to support patients using adrenaline auto-injectors SL = slovenščina 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Better training tools recommended to support patients using adrenaline auto-injectors FI = suomi 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Better training tools recommended to support patients using adrenaline auto-injectors SV = svenska 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Better training tools recommended to support patients using adrenaline auto-injectors HR = Hrvatski 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - CHMP assessment report (English only) 2015-08-26  
Adrenaline auto-injectors Article-31 referral - Review started (English only) 2014-04-25 2014-04-29
Adrenaline auto-injectors Article-31 referral - CHMP List of questions (English only) 2014-04-25  
Adrenaline auto-injectors Article-31 referral - Timetable for the procedure (English only) 2014-04-25 2015-03-02
Adrenaline auto-injectors Article-31 referral - Notification (English only) 2014-04-25  
Adrenaline auto-injectors Article-31 referral - Annex I BG = bălgarski 2014-04-25 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex I ES = español 2014-04-25 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex I CS = čeština 2014-04-25 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex I DA = dansk 2014-04-25 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex I DE = Deutsch 2014-04-25 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex I ET = eesti keel 2014-04-25 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex I EL = elliniká 2014-04-25 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex I EN = English 2014-04-25 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex I FR = français 2014-04-25 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex I IT = italiano 2014-04-25 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex I LV = latviešu valoda 2014-04-25 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex I LT = lietuvių kalba 2014-04-25 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex I HU = magyar 2014-04-25 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex I MT = Malti 2014-04-25 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex I NL = Nederlands 2014-04-25 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex I PL = polski 2014-04-25 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex I PT = português 2014-04-25 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex I RO = română 2014-04-25 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex I SK = slovenčina 2014-04-25 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex I SL = slovenščina 2014-04-25 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex I FI = suomi 2014-04-25 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex I SV = svenska 2014-04-25 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex I HR = Hrvatski 2014-04-25 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex I IS = Islenska 2014-04-25 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex I NO = Norsk 2014-04-25 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex II BG = bălgarski 2015-08-26  
Adrenaline auto-injectors Article-31 referral - Annex II ES = español 2015-08-26  
Adrenaline auto-injectors Article-31 referral - Annex II CS = čeština 2015-08-26  
Adrenaline auto-injectors Article-31 referral - Annex II DA = dansk 2015-08-26  
Adrenaline auto-injectors Article-31 referral - Annex II DE = Deutsch 2015-08-26  
Adrenaline auto-injectors Article-31 referral - Annex II ET = eesti keel 2015-08-26  
Adrenaline auto-injectors Article-31 referral - Annex II EL = elliniká 2015-08-26  
Adrenaline auto-injectors Article-31 referral - Annex II EN = English 2015-08-26  
Adrenaline auto-injectors Article-31 referral - Annex II FR = français 2015-08-26  
Adrenaline auto-injectors Article-31 referral - Annex II IT = italiano 2015-08-26  
Adrenaline auto-injectors Article-31 referral - Annex II LV = latviešu valoda 2015-08-26  
Adrenaline auto-injectors Article-31 referral - Annex II LT = lietuvių kalba 2015-08-26  
Adrenaline auto-injectors Article-31 referral - Annex II HU = magyar 2015-08-26  
Adrenaline auto-injectors Article-31 referral - Annex II MT = Malti 2015-08-26  
Adrenaline auto-injectors Article-31 referral - Annex II NL = Nederlands 2015-08-26  
Adrenaline auto-injectors Article-31 referral - Annex II PL = polski 2015-08-26  
Adrenaline auto-injectors Article-31 referral - Annex II PT = português 2015-08-26  
Adrenaline auto-injectors Article-31 referral - Annex II RO = română 2015-08-26  
Adrenaline auto-injectors Article-31 referral - Annex II SK = slovenčina 2015-08-26  
Adrenaline auto-injectors Article-31 referral - Annex II SL = slovenščina 2015-08-26  
Adrenaline auto-injectors Article-31 referral - Annex II FI = suomi 2015-08-26  
Adrenaline auto-injectors Article-31 referral - Annex II SV = svenska 2015-08-26  
Adrenaline auto-injectors Article-31 referral - Annex II HR = Hrvatski 2015-08-26  
Adrenaline auto-injectors Article-31 referral - Annex III BG = bălgarski 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex III ES = español 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex III CS = čeština 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex III DA = dansk 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex III DE = Deutsch 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex III ET = eesti keel 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex III EL = elliniká 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex III EN = English 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex III FR = français 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex III IT = italiano 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex III LV = latviešu valoda 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex III LT = lietuvių kalba 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex III HU = magyar 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex III MT = Malti 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex III NL = Nederlands 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex III PL = polski 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex III PT = português 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex III RO = română 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex III SK = slovenčina 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex III SL = slovenščina 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex III FI = suomi 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex III SV = svenska 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex III HR = Hrvatski 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex III IS = Islenska 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex III NO = Norsk 2015-06-26 2015-08-26
Adrenaline auto-injectors Article-31 referral - Annex IV BG = bălgarski 2015-08-26  
Adrenaline auto-injectors Article-31 referral - Annex IV ES = español 2015-08-26  
Adrenaline auto-injectors Article-31 referral - Annex IV CS = čeština 2015-08-26  
Adrenaline auto-injectors Article-31 referral - Annex IV DA = dansk 2015-08-26  
Adrenaline auto-injectors Article-31 referral - Annex IV DE = Deutsch 2015-08-26  
Adrenaline auto-injectors Article-31 referral - Annex IV ET = eesti keel 2015-08-26  
Adrenaline auto-injectors Article-31 referral - Annex IV EL = elliniká 2015-08-26  
Adrenaline auto-injectors Article-31 referral - Annex IV EN = English 2015-08-26  
Adrenaline auto-injectors Article-31 referral - Annex IV FR = français 2015-08-26  
Adrenaline auto-injectors Article-31 referral - Annex IV IT = italiano 2015-08-26  
Adrenaline auto-injectors Article-31 referral - Annex IV LV = latviešu valoda 2015-08-26  
Adrenaline auto-injectors Article-31 referral - Annex IV LT = lietuvių kalba 2015-08-26  
Adrenaline auto-injectors Article-31 referral - Annex IV HU = magyar 2015-08-26  
Adrenaline auto-injectors Article-31 referral - Annex IV MT = Malti 2015-08-26  
Adrenaline auto-injectors Article-31 referral - Annex IV NL = Nederlands 2015-08-26  
Adrenaline auto-injectors Article-31 referral - Annex IV PL = polski 2015-08-26  
Adrenaline auto-injectors Article-31 referral - Annex IV PT = português 2015-08-26  
Adrenaline auto-injectors Article-31 referral - Annex IV RO = română 2015-08-26  
Adrenaline auto-injectors Article-31 referral - Annex IV SK = slovenčina 2015-08-26  
Adrenaline auto-injectors Article-31 referral - Annex IV SL = slovenščina 2015-08-26  
Adrenaline auto-injectors Article-31 referral - Annex IV FI = suomi 2015-08-26  
Adrenaline auto-injectors Article-31 referral - Annex IV SV = svenska 2015-08-26  
Adrenaline auto-injectors Article-31 referral - Annex IV HR = Hrvatski 2015-08-26  

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

More information on Adrenaline auto injectors