Rocephin

  • Email
  • Help

On 23 January 2014, the European Medicines Agency completed a review of Rocephin. The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Rocephin in the European Union (EU).

What is Rocephin?

Rocephin is a medicine that contains the active substance ceftriaxone. It is an antibiotic used to treat a wide range of bacterial infections including pneumonia (infection of the lungs) and meningitis (infection of the membranes around the brain and spine). Ceftriaxone belongs to the group ‘cephalosporins’; it works by attaching to proteins on the surface of bacteria. This prevents the bacteria from building their cell walls, and eventually kills them.

Rocephin is marketed in the following EU Member States: Belgium, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Luxembourg, Malta, the Netherlands, Portugal, Romania, Sweden and the United Kingdom, as well as Iceland. It is also available in the EU under other trade names: Rocefin, Rocephalin, Rocephalin cum lidocain, Rocephine.

The company that markets these medicines is Roche.

Why was Rocephin reviewed?

Rocephin is 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.

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

On 9 December 2011, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Rocephin 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 Rocephin should no longer be used to treat sinusitis (inflammation of the sinuses), pharyngitis (sore throat) and prostatitis (inflammation of the prostate, a gland of the male reproductive system) because not enough clinical data are available to support these indications. The CHMP concluded that Rocephin should be used to treat the following infections in adults and children, which were already approved in several but not all EU Member States:

  • bacterial meningitis;
  • hospital- and community-acquired pneumonia (infection of the lungs caught in or outside the hospital);
  • acute otitis media (infection of the middle ear);
  • intra-abdominal infections (infections within the abdomen);
  • complicated urinary tract infections, including pyelonephritis (kidney infection);
  • infections of bones and joints;
  • complicated skin and soft tissue infections;
  • the sexually transmitted infections gonorrhoea and syphilis;
  • bacterial endocarditis (an infection in the heart).

Rocephin may be used to treat acute exacerbations (flare-ups) of chronic obstructive pulmonary disease in adults. It may also be used to treat disseminated Lyme borreliosis (a bacterial infection spread to humans by infected ticks) in adults and children including neonates from 15 days of age.

Rocephin may be used to manage patients with neutropenia (low levels of neutrophils, a type of white blood cell) who also have fever suspected to be caused by bacterial infection, patients with bacteraemia (when the bacteria are detected in the blood) suspected to be caused by any of the infections mentioned above, and for the pre-operative prevention of surgical site infections.

4.2 Posology and method of administration

Having harmonised the indications, the CHMP also harmonised the recommendations on how to use Rocephin in adults and children. Rocephin should preferably be given into a vein by injection over a period of 5 minutes or by infusion (drip) over at least 30 minutes, or else by deep intramuscular injection.

In adults and children over 12 years of age, the recommended dose varies between 1 and 4 g of Rocephin once daily depending on the condition it is used to treat. In children below 12 years of age, the recommended dose of Rocephin depends on body weight and the condition it is used to treat.

Other changes

The CHMP also harmonised other sections of the SmPC including section 4.3 (contraindications), 4.4 (special warnings and precautions for use) and 4.6 (pregnancy and lactation).

Name Language First published Last updated
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) BG = bălgarski 2014-01-24 2014-05-19
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) ES = español 2014-01-24 2014-05-19
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) CS = čeština 2014-01-24 2014-05-19
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) DA = dansk 2014-01-24 2014-05-19
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) DE = Deutsch 2014-01-24 2014-05-19
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) ET = eesti keel 2014-01-24 2014-05-19
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) EL = elliniká 2014-01-24 2014-05-19
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) EN = English 2014-01-24 2014-05-19
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) FR = français 2014-01-24 2014-05-19
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) IT = italiano 2014-01-24 2014-05-19
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) LV = latviešu valoda 2014-01-24 2014-05-19
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) LT = lietuvių kalba 2014-01-24 2014-05-19
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) HU = magyar 2014-01-24 2014-05-19
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) MT = Malti 2014-01-24 2014-05-19
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) NL = Nederlands 2014-01-24 2014-05-19
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) PL = polski 2014-01-24 2014-05-19
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) PT = português 2014-01-24 2014-05-19
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) RO = română 2014-01-24 2014-05-19
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) SK = slovenčina 2014-01-24 2014-05-19
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) SL = slovenščina 2014-01-24 2014-05-19
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) FI = suomi 2014-01-24 2014-05-19
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) SV = svenska 2014-01-24 2014-05-19
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) HR = Hrvatski 2014-01-24 2014-05-19

Key facts

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

ceftriaxone

Associated names
Class
Reference numberEMEA/H/A-30/1302
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 date23/01/2014

All documents

Name Language First published Last updated
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) BG = bălgarski 2014-01-24 2014-05-19
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) ES = español 2014-01-24 2014-05-19
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) CS = čeština 2014-01-24 2014-05-19
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) DA = dansk 2014-01-24 2014-05-19
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) DE = Deutsch 2014-01-24 2014-05-19
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) ET = eesti keel 2014-01-24 2014-05-19
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) EL = elliniká 2014-01-24 2014-05-19
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) EN = English 2014-01-24 2014-05-19
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) FR = français 2014-01-24 2014-05-19
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) IT = italiano 2014-01-24 2014-05-19
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) LV = latviešu valoda 2014-01-24 2014-05-19
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) LT = lietuvių kalba 2014-01-24 2014-05-19
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) HU = magyar 2014-01-24 2014-05-19
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) MT = Malti 2014-01-24 2014-05-19
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) NL = Nederlands 2014-01-24 2014-05-19
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) PL = polski 2014-01-24 2014-05-19
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) PT = português 2014-01-24 2014-05-19
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) RO = română 2014-01-24 2014-05-19
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) SK = slovenčina 2014-01-24 2014-05-19
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) SL = slovenščina 2014-01-24 2014-05-19
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) FI = suomi 2014-01-24 2014-05-19
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) SV = svenska 2014-01-24 2014-05-19
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) HR = Hrvatski 2014-01-24 2014-05-19
Rocephin Article-30 referral - Assessment report (English only) 2014-05-19  
Rocephin Article-30 referral - Annex I BG = bălgarski 2014-05-19  
Rocephin Article-30 referral - Annex I ES = español 2014-05-19  
Rocephin Article-30 referral - Annex I CS = čeština 2014-05-19  
Rocephin Article-30 referral - Annex I DA = dansk 2014-05-19  
Rocephin Article-30 referral - Annex I DE = Deutsch 2014-05-19  
Rocephin Article-30 referral - Annex I ET = eesti keel 2014-05-19  
Rocephin Article-30 referral - Annex I EL = elliniká 2014-05-19  
Rocephin Article-30 referral - Annex I EN = English 2014-05-19  
Rocephin Article-30 referral - Annex I FR = français 2014-05-19  
Rocephin Article-30 referral - Annex I IT = italiano 2014-05-19  
Rocephin Article-30 referral - Annex I LV = latviešu valoda 2014-05-19  
Rocephin Article-30 referral - Annex I LT = lietuvių kalba 2014-05-19  
Rocephin Article-30 referral - Annex I HU = magyar 2014-05-19  
Rocephin Article-30 referral - Annex I MT = Malti 2014-05-19  
Rocephin Article-30 referral - Annex I NL = Nederlands 2014-05-19  
Rocephin Article-30 referral - Annex I PL = polski 2014-05-19  
Rocephin Article-30 referral - Annex I PT = português 2014-05-19  
Rocephin Article-30 referral - Annex I RO = română 2014-05-19  
Rocephin Article-30 referral - Annex I SK = slovenčina 2014-05-19  
Rocephin Article-30 referral - Annex I SL = slovenščina 2014-05-19  
Rocephin Article-30 referral - Annex I FI = suomi 2014-05-19  
Rocephin Article-30 referral - Annex I SV = svenska 2014-05-19  
Rocephin Article-30 referral - Annex I HR = Hrvatski 2014-05-19  
Rocephin Article-30 referral - Annex I IS = Islenska 2014-05-19  
Rocephin Article-30 referral - Annex II BG = bălgarski 2014-05-19  
Rocephin Article-30 referral - Annex II ES = español 2014-05-19  
Rocephin Article-30 referral - Annex II CS = čeština 2014-05-19  
Rocephin Article-30 referral - Annex II DA = dansk 2014-05-19  
Rocephin Article-30 referral - Annex II DE = Deutsch 2014-05-19  
Rocephin Article-30 referral - Annex II ET = eesti keel 2014-05-19  
Rocephin Article-30 referral - Annex II EL = elliniká 2014-05-19  
Rocephin Article-30 referral - Annex II EN = English 2014-05-19  
Rocephin Article-30 referral - Annex II FR = français 2014-05-19  
Rocephin Article-30 referral - Annex II IT = italiano 2014-05-19  
Rocephin Article-30 referral - Annex II LV = latviešu valoda 2014-05-19  
Rocephin Article-30 referral - Annex II LT = lietuvių kalba 2014-05-19  
Rocephin Article-30 referral - Annex II HU = magyar 2014-05-19  
Rocephin Article-30 referral - Annex II MT = Malti 2014-05-19  
Rocephin Article-30 referral - Annex II NL = Nederlands 2014-05-19  
Rocephin Article-30 referral - Annex II PL = polski 2014-05-19  
Rocephin Article-30 referral - Annex II PT = português 2014-05-19  
Rocephin Article-30 referral - Annex II RO = română 2014-05-19  
Rocephin Article-30 referral - Annex II SK = slovenčina 2014-05-19  
Rocephin Article-30 referral - Annex II SL = slovenščina 2014-05-19  
Rocephin Article-30 referral - Annex II FI = suomi 2014-05-19  
Rocephin Article-30 referral - Annex II SV = svenska 2014-05-19  
Rocephin Article-30 referral - Annex II HR = Hrvatski 2014-05-19  
Rocephin Article-30 referral - Annex III BG = bălgarski 2014-01-24 2014-05-19
Rocephin Article-30 referral - Annex III ES = español 2014-01-24 2014-05-19
Rocephin Article-30 referral - Annex III CS = čeština 2014-01-24 2014-05-19
Rocephin Article-30 referral - Annex III DA = dansk 2014-01-24 2014-05-19
Rocephin Article-30 referral - Annex III DE = Deutsch 2014-01-24 2014-05-19
Rocephin Article-30 referral - Annex III ET = eesti keel 2014-01-24 2014-05-19
Rocephin Article-30 referral - Annex III EL = elliniká 2014-01-24 2014-05-19
Rocephin Article-30 referral - Annex III EN = English 2014-01-24 2014-05-19
Rocephin Article-30 referral - Annex III FR = français 2014-01-24 2014-05-19
Rocephin Article-30 referral - Annex III IT = italiano 2014-01-24 2014-05-19
Rocephin Article-30 referral - Annex III LV = latviešu valoda 2014-01-24 2014-05-19
Rocephin Article-30 referral - Annex III LT = lietuvių kalba 2014-01-24 2014-05-19
Rocephin Article-30 referral - Annex III HU = magyar 2014-01-24 2014-05-19
Rocephin Article-30 referral - Annex III MT = Malti 2014-01-24 2014-05-19
Rocephin Article-30 referral - Annex III NL = Nederlands 2014-01-24 2014-05-19
Rocephin Article-30 referral - Annex III PL = polski 2014-01-24 2014-05-19
Rocephin Article-30 referral - Annex III PT = português 2014-01-24 2014-05-19
Rocephin Article-30 referral - Annex III RO = română 2014-01-24 2014-05-19
Rocephin Article-30 referral - Annex III SK = slovenčina 2014-01-24 2014-05-19
Rocephin Article-30 referral - Annex III SL = slovenščina 2014-01-24 2014-05-19
Rocephin Article-30 referral - Annex III FI = suomi 2014-01-24 2014-05-19
Rocephin Article-30 referral - Annex III SV = svenska 2014-01-24 2014-05-19
Rocephin Article-30 referral - Annex III HR = Hrvatski 2014-01-24 2014-05-19
Rocephin Article-30 referral - Annex III IS = Islenska 2014-01-24 2014-05-19

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 Rocephin