Amoxil

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On 25 June 2015, the European Medicines Agency completed a review of Amoxil. The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Amoxil in the European Union (EU).

What is Amoxil?

Amoxil is an antibiotic used to treat a wide range of bacterial infections. It contains the active substance amoxicillin which belongs to the ‘beta-lactam’ family (the family that includes penicillins). It works by attaching to proteins on the surface of bacteria. This prevents the bacteria from building their cell walls, and eventually kills them.

Amoxil is marketed in the following EU Member States: Belgium, Cyprus, France, Greece, Ireland, Latvia, Lithuania, Luxembourg, Malta, Portugal, Spain and the United Kingdom. In some countries it is available under the trade names Amoxicilline Biogaran and Clamoxyl.

The company that markets these medicines is GlaxoSmithKline.

Why was Amoxil reviewed?

Amoxil has been authorised in the EU via national procedures. This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.

Amoxil was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh).

On 22 July 2013, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Amoxil in the EU.

What are the conclusions of the CHMP?

The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.

The areas harmonised include:

4.1 Therapeutic indications

The CHMP agreed that the oral (to be taken by mouth) formulations of Amoxil (such as capsules, tablets and suspensions) can be used in adults and children for the treatment of the following bacterial infections:

  • Acute bacterial sinusitis (infection of the sinuses);
  • Acute otitis media (infection of the middle ear);
  • Acute streptococcal tonsillitis and pharyngitis (infections of the tonsils and throat);
  • Acute exacerbations (flare-ups) of chronic bronchitis (inflammation of the airways in the lungs);
  • Community acquired pneumonia (infection of the lungs acquired outside the hospital);
  • Acute cystitis (infection of the bladder);
  • Asymptomatic bacteriuria (bacteria detected in the urine) in pregnancy;
  • Acute pyelonephritis (kidney infection);
  • Typhoid and paratyphoid fever;
  • Dental abscess with spreading cellulitis (inflammation of the deep skin tissue);
  • Prosthetic joint infections;
  • Helicobacter pylori eradication;
  • Lyme disease.

Oral Amoxil can also be used for the prevention of endocarditis (infection of the inner lining of the heart).

Amoxil is also available as a solution for injection or infusion (drip) into a vein, and as a solution for injection into a muscle. These formulations can be used to treat adults and children with the following bacterial infections:

  • Severe infections of the ear, nose and throat (such as mastoiditis, peritonsillar infections, epiglottitis, and sinusitis when accompanied by severe systemic signs and symptoms);
  • Acute exacerbations of chronic bronchitis;
  • Community acquired pneumonia;
  • Acute cystitis;
  • Acute pyelonephritis;
  • Severe dental abscess with spreading cellulitis;
  • Prosthetic joint infections;
  • Lyme disease;
  • Bacterial meningitis (infection of the membranes around the brain and spine);
  • Bacteraemia (bacteria detected in the blood) that occurs in association with, or is suspected to be associated with, any of the infections listed above.

The injectable formulations can also be used for the treatment and prevention of endocarditis.

The CHMP also agreed that Amoxil should no longer be used to treat female genital infections, because not enough clinical data are available to support this indication. Additionally, Amoxil should no longer be used in several other indications (treatment of bronchitis, acute lung disease, urethritis (inflammation of the urethra, the tube that carries urine from the bladder out of the body), gonococcal infections, male genital infections, gonorrhoea (a sexually transmitted infection caused by bacteria called Neisseria gonorrhoeae), enteritis (inflammation of the small intestine) with bacteraemia and intra-abdominal infections such as peritonitis, cholecystitis and acute cholangitis, and serious infections caused by Haemophilus influenzae). This is either because antibiotics are no longer used to treat these conditions, or because other antibiotics have been shown to be more effective than amoxicillin.

4.2 Posology and method of administration

Having harmonised the indications, the CHMP also harmonised the recommendations on how to use Amoxil. The recommended dose of Amoxil varies depending on the infection it is used to treat, the way it is given, and the age and weight of the patient. Doses range from 250 mg to 2 g two or three times a day for adults and children weighing more than 40 kilograms, and from 20 to 200 mg per kilogram per day for children weighing less than 40 kilograms.

4.3 Contraindications

The CHMP agreed that Amoxil must not be used in patients who are hypersensitive (allergic) to amoxicillin or any other ingredients of Amoxil, and to any of the penicillins. Additionally, Amoxil must not be used in patients who have had severe allergic reactions to another type of beta-lactam antibiotic (e.g. a cephalosporin, carbapenem or monobactam).

Other changes

The Committee also harmonised other sections of the SmPC including sections 4.4 (special warnings and precautions for use), 4.6 (fertility, pregnancy and lactation), and 4.8 (side effects).

A decision on this opinion was issued by the European Commission on 20/08/2015.

Name Language First published Last updated
Questions and answers on Amoxil and associated names (amoxicillin) BG = bălgarski 2015-06-26 2016-05-19
Questions and answers on Amoxil and associated names (amoxicillin) ES = español 2015-06-26 2016-05-19
Questions and answers on Amoxil and associated names (amoxicillin) CS = čeština 2015-06-26 2016-05-19
Questions and answers on Amoxil and associated names (amoxicillin) DA = dansk 2015-06-26 2016-05-19
Questions and answers on Amoxil and associated names (amoxicillin) DE = Deutsch 2015-06-26 2016-05-19
Questions and answers on Amoxil and associated names (amoxicillin) ET = eesti keel 2015-06-26 2016-05-19
Questions and answers on Amoxil and associated names (amoxicillin) EL = elliniká 2015-06-26 2016-05-19
Questions and answers on Amoxil and associated names (amoxicillin) EN = English 2015-06-26 2016-05-19
Questions and answers on Amoxil and associated names (amoxicillin) FR = français 2015-06-26 2016-05-19
Questions and answers on Amoxil and associated names (amoxicillin) IT = italiano 2015-06-26 2016-05-19
Questions and answers on Amoxil and associated names (amoxicillin) LV = latviešu valoda 2015-06-26 2016-05-19
Questions and answers on Amoxil and associated names (amoxicillin) LT = lietuvių kalba 2015-06-26 2016-05-19
Questions and answers on Amoxil and associated names (amoxicillin) HU = magyar 2015-06-26 2016-05-19
Questions and answers on Amoxil and associated names (amoxicillin) MT = Malti 2015-06-26 2016-05-19
Questions and answers on Amoxil and associated names (amoxicillin) NL = Nederlands 2015-06-26 2016-05-19
Questions and answers on Amoxil and associated names (amoxicillin) PL = polski 2015-06-26 2016-05-19
Questions and answers on Amoxil and associated names (amoxicillin) PT = português 2015-06-26 2016-05-19
Questions and answers on Amoxil and associated names (amoxicillin) RO = română 2015-06-26 2016-05-19
Questions and answers on Amoxil and associated names (amoxicillin) SK = slovenčina 2015-06-26 2016-05-19
Questions and answers on Amoxil and associated names (amoxicillin) SL = slovenščina 2015-06-26 2016-05-19
Questions and answers on Amoxil and associated names (amoxicillin) FI = suomi 2015-06-26 2016-05-19
Questions and answers on Amoxil and associated names (amoxicillin) SV = svenska 2015-06-26 2016-05-19
Questions and answers on Amoxil and associated names (amoxicillin) HR = Hrvatski 2015-06-26 2016-05-19

Key facts

Approved nameAmoxil
International non-proprietary name (INN) or common name

amoxicillin

Associated names-
Class-
Reference numberEMEA/H/A-30/1372
TypeArticle 30 referrals

This type of referral is triggered when Member States have adopted different decisions over the years for some medicines (e.g. different indications, contraindications or posology) and there is a need to harmonise across the European Union.

StatusEuropean Commission final decision
Opinion date25/06/2015

All documents

Name Language First published Last updated
Amoxil Article-30 referral - Assessment report (English only) 2015-09-14  
Questions and answers on Amoxil and associated names (amoxicillin) BG = bălgarski 2015-06-26 2016-05-19
Questions and answers on Amoxil and associated names (amoxicillin) ES = español 2015-06-26 2016-05-19
Questions and answers on Amoxil and associated names (amoxicillin) CS = čeština 2015-06-26 2016-05-19
Questions and answers on Amoxil and associated names (amoxicillin) DA = dansk 2015-06-26 2016-05-19
Questions and answers on Amoxil and associated names (amoxicillin) DE = Deutsch 2015-06-26 2016-05-19
Questions and answers on Amoxil and associated names (amoxicillin) ET = eesti keel 2015-06-26 2016-05-19
Questions and answers on Amoxil and associated names (amoxicillin) EL = elliniká 2015-06-26 2016-05-19
Questions and answers on Amoxil and associated names (amoxicillin) EN = English 2015-06-26 2016-05-19
Questions and answers on Amoxil and associated names (amoxicillin) FR = français 2015-06-26 2016-05-19
Questions and answers on Amoxil and associated names (amoxicillin) IT = italiano 2015-06-26 2016-05-19
Questions and answers on Amoxil and associated names (amoxicillin) LV = latviešu valoda 2015-06-26 2016-05-19
Questions and answers on Amoxil and associated names (amoxicillin) LT = lietuvių kalba 2015-06-26 2016-05-19
Questions and answers on Amoxil and associated names (amoxicillin) HU = magyar 2015-06-26 2016-05-19
Questions and answers on Amoxil and associated names (amoxicillin) MT = Malti 2015-06-26 2016-05-19
Questions and answers on Amoxil and associated names (amoxicillin) NL = Nederlands 2015-06-26 2016-05-19
Questions and answers on Amoxil and associated names (amoxicillin) PL = polski 2015-06-26 2016-05-19
Questions and answers on Amoxil and associated names (amoxicillin) PT = português 2015-06-26 2016-05-19
Questions and answers on Amoxil and associated names (amoxicillin) RO = română 2015-06-26 2016-05-19
Questions and answers on Amoxil and associated names (amoxicillin) SK = slovenčina 2015-06-26 2016-05-19
Questions and answers on Amoxil and associated names (amoxicillin) SL = slovenščina 2015-06-26 2016-05-19
Questions and answers on Amoxil and associated names (amoxicillin) FI = suomi 2015-06-26 2016-05-19
Questions and answers on Amoxil and associated names (amoxicillin) SV = svenska 2015-06-26 2016-05-19
Questions and answers on Amoxil and associated names (amoxicillin) HR = Hrvatski 2015-06-26 2016-05-19
Amoxil Article-30 referral - Annex I BG = bălgarski 2015-09-14  
Amoxil Article-30 referral - Annex I ES = español 2015-09-14  
Amoxil Article-30 referral - Annex I CS = čeština 2015-09-14  
Amoxil Article-30 referral - Annex I DA = dansk 2015-09-14  
Amoxil Article-30 referral - Annex I DE = Deutsch 2015-09-14  
Amoxil Article-30 referral - Annex I ET = eesti keel 2015-09-14  
Amoxil Article-30 referral - Annex I EL = elliniká 2015-09-14  
Amoxil Article-30 referral - Annex I EN = English 2015-09-14  
Amoxil Article-30 referral - Annex I FR = français 2015-09-14  
Amoxil Article-30 referral - Annex I IT = italiano 2015-09-14  
Amoxil Article-30 referral - Annex I LV = latviešu valoda 2015-09-14  
Amoxil Article-30 referral - Annex I LT = lietuvių kalba 2015-09-14  
Amoxil Article-30 referral - Annex I HU = magyar 2015-09-14  
Amoxil Article-30 referral - Annex I MT = Malti 2015-09-14  
Amoxil Article-30 referral - Annex I NL = Nederlands 2015-09-14  
Amoxil Article-30 referral - Annex I PL = polski 2015-09-14  
Amoxil Article-30 referral - Annex I PT = português 2015-09-14  
Amoxil Article-30 referral - Annex I RO = română 2015-09-14  
Amoxil Article-30 referral - Annex I SK = slovenčina 2015-09-14  
Amoxil Article-30 referral - Annex I SL = slovenščina 2015-09-14  
Amoxil Article-30 referral - Annex I FI = suomi 2015-09-14  
Amoxil Article-30 referral - Annex I SV = svenska 2015-09-14  
Amoxil Article-30 referral - Annex I HR = Hrvatski 2015-09-14  
Amoxil Article-30 referral - Annex I IS = Islenska 2015-09-14  
Amoxil Article-30 referral - Annex I NO = Norsk 2015-09-14  
Amoxil Article-30 referral - Annex II BG = bălgarski 2015-09-14  
Amoxil Article-30 referral - Annex II ES = español 2015-09-14  
Amoxil Article-30 referral - Annex II CS = čeština 2015-09-14  
Amoxil Article-30 referral - Annex II DA = dansk 2015-09-14  
Amoxil Article-30 referral - Annex II DE = Deutsch 2015-09-14  
Amoxil Article-30 referral - Annex II ET = eesti keel 2015-09-14  
Amoxil Article-30 referral - Annex II EL = elliniká 2015-09-14  
Amoxil Article-30 referral - Annex II EN = English 2015-09-14  
Amoxil Article-30 referral - Annex II FR = français 2015-09-14  
Amoxil Article-30 referral - Annex II IT = italiano 2015-09-14  
Amoxil Article-30 referral - Annex II LV = latviešu valoda 2015-09-14  
Amoxil Article-30 referral - Annex II LT = lietuvių kalba 2015-09-14  
Amoxil Article-30 referral - Annex II HU = magyar 2015-09-14  
Amoxil Article-30 referral - Annex II MT = Malti 2015-09-14  
Amoxil Article-30 referral - Annex II NL = Nederlands 2015-09-14  
Amoxil Article-30 referral - Annex II PL = polski 2015-09-14  
Amoxil Article-30 referral - Annex II PT = português 2015-09-14  
Amoxil Article-30 referral - Annex II RO = română 2015-09-14  
Amoxil Article-30 referral - Annex II SK = slovenčina 2015-09-14  
Amoxil Article-30 referral - Annex II SL = slovenščina 2015-09-14  
Amoxil Article-30 referral - Annex II FI = suomi 2015-09-14  
Amoxil Article-30 referral - Annex II SV = svenska 2015-09-14  
Amoxil Article-30 referral - Annex II HR = Hrvatski 2015-09-14  
Amoxil Article-30 referral - Annex III BG = bălgarski 2015-06-26 2015-09-14
Amoxil Article-30 referral - Annex III ES = español 2015-06-26 2015-09-14
Amoxil Article-30 referral - Annex III DA = dansk 2015-06-26 2015-09-14
Amoxil Article-30 referral - Annex III DE = Deutsch 2015-06-26 2015-09-14
Amoxil Article-30 referral - Annex III ET = eesti keel 2015-06-26 2015-09-14
Amoxil Article-30 referral - Annex III EL = elliniká 2015-06-26 2015-09-14
Amoxil Article-30 referral - Annex III EN = English 2015-06-26 2015-09-14
Amoxil Article-30 referral - Annex III FR = français 2015-06-26 2015-09-14
Amoxil Article-30 referral - Annex III IT = italiano 2015-06-26 2015-09-14
Amoxil Article-30 referral - Annex III LV = latviešu valoda 2015-06-26 2015-09-14
Amoxil Article-30 referral - Annex III LT = lietuvių kalba 2015-06-26 2015-09-14
Amoxil Article-30 referral - Annex III HU = magyar 2015-06-26 2015-09-14
Amoxil Article-30 referral - Annex III MT = Malti 2015-06-26 2015-09-14
Amoxil Article-30 referral - Annex III NL = Nederlands 2015-06-26 2015-09-14
Amoxil Article-30 referral - Annex III PL = polski 2015-06-26 2015-09-14
Amoxil Article-30 referral - Annex III PT = português 2015-06-26 2015-09-14
Amoxil Article-30 referral - Annex III RO = română 2015-06-26 2015-09-14
Amoxil Article-30 referral - Annex III SK = slovenčina 2015-06-26 2015-09-14
Amoxil Article-30 referral - Annex III SL = slovenščina 2015-06-26 2015-09-14
Amoxil Article-30 referral - Annex III FI = suomi 2015-06-26 2015-09-14
Amoxil Article-30 referral - Annex III SV = svenska 2015-06-26 2015-09-14
Amoxil Article-30 referral - Annex III HR = Hrvatski 2015-06-26 2015-09-14
Amoxil Article-30 referral - Annex III IS = Islenska 2015-06-26 2015-09-14
Amoxil Article-30 referral - Annex III NO = Norsk 2015-06-26 2015-09-14

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 Amoxil