Methylphenidate Sandoz

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On 25 July 2013, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Methylphenidate Sandoz. The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Methylphenidate Sandoz outweigh its risks, and the marketing authorisation granted in Denmark can be recognised in other Member States of the EU.

What is Methylphenidate Sandoz?

Methylphenidate is a medicine that is used to treat children aged between 6 and 18 years of age who have attention-deficit / hyperactivity disorder (ADHD), a condition in which children show a persistent inability to concentrate, hyperactivity and impulsive behaviour.

Methylphenidate belongs to a group of medicines called ‘psychostimulants’ and is thought to work by enhancing the activity of areas of the brain that control attention and concentration. It has been available since the 1950s as both immediate-release tablets and capsules, which release methylphenidate straight away, and as modified-release tablets that release some or all of the active substance more slowly over several hours.

Methylphenidate Sandoz is a generic medicine based on a ‘reference medicine’, Concerta, which is authorised in all the EU Member States. It is available as a modified-release tablet, which releases some of the active substance immediately (the ‘immediate-release phase’) and the rest over several hours.

Why was Methylphenidate Sandoz reviewed?

Sandoz A/S submitted Methylphenidate Sandoz for mutual recognition on the basis of the initial authorisation granted by Denmark on 29 March 2012 and also valid through a decentralised procedure in Cyprus, Finland, Poland, Portugal and Spain, as well as Iceland and Norway. The company wanted the authorisation to be recognised in Belgium, France, Germany, Luxembourg, Malta, Netherlands, Sweden and United Kingdom (the ‘concerned Member States’).

However, the Member States were not able to reach an agreement and the Danish medicines regulatory agency referred the matter to the CHMP for arbitration on 21 December 2012.

The grounds for the referral were objections raised by Germany and the Netherlands, which considered that the bioequivalence study carried out under fed conditions did not show that Methylphenidate Sandoz was bioequivalent for the immediate-release phase to its reference product. As the product information states that the tablet can be taken with or without food, a bioequivalence study in fed conditions was required to grant the marketing authorisation. Two medicines are bioequivalent if they produce the same levels of the active substance in the body.

What are the conclusions of the CHMP?

Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the failure to show bioequivalence between Methylphenidate Sandoz and its reference medicine in the immediate-release phase under fed conditions were due to differences between patients in the effects of a high-fat meal on the way medicines are handled by the body, and not to differences between the formulations of the two medicinal products, and that bioequivalence to the reference medicinal product has been shown. The Committee also noted that the studies were performed by the applicant before the publication of recent updated guidance* for products of this type. The CHMP therefore concluded that the benefits of Methylphenidate Sandoz outweigh its risks and recommended that the marketing authorisation be granted in the concerned Member States.

The European Commission issued a decision on this opinion on 09 October 2013.


*Committee for Human Medicinal Products. Questions & Answers: Positions on specific questions addressed to the pharmacokinetics working party. 11. Requirements for demonstration of bioequivalence for generics of biphasic modified release formulations for oral use. EMA/618604/2008 Rev. 7.

Name Language First published Last updated
Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) BG = bălgarski 26/07/2013 05/12/2013
Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) ES = español 26/07/2013 05/12/2013
Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) CS = čeština 26/07/2013 05/12/2013
Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) DA = dansk 26/07/2013 05/12/2013
Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) DE = Deutsch 26/07/2013 05/12/2013
Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) ET = eesti keel 26/07/2013 05/12/2013
Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) EL = elliniká 26/07/2013 05/12/2013
Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) EN = English 26/07/2013 05/12/2013
Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) FR = français 26/07/2013 05/12/2013
Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) IT = italiano 26/07/2013 05/12/2013
Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) LV = latviešu valoda 26/07/2013 05/12/2013
Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) LT = lietuvių kalba 26/07/2013 05/12/2013
Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) HU = magyar 26/07/2013 05/12/2013
Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) MT = Malti 26/07/2013 05/12/2013
Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) NL = Nederlands 26/07/2013 05/12/2013
Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) PL = polski 26/07/2013 05/12/2013
Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) PT = português 26/07/2013 05/12/2013
Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) RO = română 26/07/2013 05/12/2013
Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) SK = slovenčina 26/07/2013 05/12/2013
Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) SL = slovenščina 26/07/2013 05/12/2013
Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) FI = suomi 26/07/2013 05/12/2013
Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) SV = svenska 26/07/2013 05/12/2013
Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) HR = Hrvatski 26/07/2013 05/12/2013

Key facts

Approved nameMethylphenidate Sandoz
International non-proprietary name (INN) or common name

methylphenidate hydrochloride

Associated names-
Class-
Reference numberEMEA/H/A-29/1359
TypeArticle 29(4) referrals

This type of referral is triggered when there is a disagreement between Member States regarding a medicine being evaluated during a mutual-recognition or decentralised procedure, on the grounds of a potential serious risk to public health.

StatusEuropean Commission final decision
Opinion date25/07/2013

All documents

Name Language First published Last updated
Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) BG = bălgarski 26/07/2013 05/12/2013
Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) ES = español 26/07/2013 05/12/2013
Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) CS = čeština 26/07/2013 05/12/2013
Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) DA = dansk 26/07/2013 05/12/2013
Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) DE = Deutsch 26/07/2013 05/12/2013
Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) ET = eesti keel 26/07/2013 05/12/2013
Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) EL = elliniká 26/07/2013 05/12/2013
Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) EN = English 26/07/2013 05/12/2013
Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) FR = français 26/07/2013 05/12/2013
Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) IT = italiano 26/07/2013 05/12/2013
Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) LV = latviešu valoda 26/07/2013 05/12/2013
Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) LT = lietuvių kalba 26/07/2013 05/12/2013
Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) HU = magyar 26/07/2013 05/12/2013
Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) MT = Malti 26/07/2013 05/12/2013
Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) NL = Nederlands 26/07/2013 05/12/2013
Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) PL = polski 26/07/2013 05/12/2013
Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) PT = português 26/07/2013 05/12/2013
Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) RO = română 26/07/2013 05/12/2013
Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) SK = slovenčina 26/07/2013 05/12/2013
Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) SL = slovenščina 26/07/2013 05/12/2013
Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) FI = suomi 26/07/2013 05/12/2013
Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) SV = svenska 26/07/2013 05/12/2013
Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) HR = Hrvatski 26/07/2013 05/12/2013
Methylphenidate Sandoz Article-29 referral - Annex I BG = bălgarski 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex I ES = español 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex I CS = čeština 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex I DA = dansk 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex I DE = Deutsch 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex I ET = eesti keel 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex I EL = elliniká 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex I EN = English 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex I FR = français 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex I IT = italiano 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex I LV = latviešu valoda 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex I LT = lietuvių kalba 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex I HU = magyar 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex I MT = Malti 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex I NL = Nederlands 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex I PL = polski 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex I PT = português 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex I RO = română 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex I SK = slovenčina 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex I SL = slovenščina 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex I FI = suomi 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex I SV = svenska 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex I HR = Hrvatski 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex I IS = Islenska 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex I NO = Norsk 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex II BG = bălgarski 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex II ES = español 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex II CS = čeština 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex II DA = dansk 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex II DE = Deutsch 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex II ET = eesti keel 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex II EL = elliniká 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex II EN = English 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex II FR = français 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex II IT = italiano 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex II LV = latviešu valoda 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex II LT = lietuvių kalba 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex II HU = magyar 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex II MT = Malti 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex II NL = Nederlands 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex II PL = polski 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex II PT = português 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex II RO = română 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex II SK = slovenčina 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex II SL = slovenščina 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex II FI = suomi 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex II SV = svenska 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex II HR = Hrvatski 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex III BG = bălgarski 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex III ES = español 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex III CS = čeština 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex III DA = dansk 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex III DE = Deutsch 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex III ET = eesti keel 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex III EL = elliniká 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex III EN = English 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex III FR = français 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex III IT = italiano 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex III LV = latviešu valoda 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex III LT = lietuvių kalba 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex III HU = magyar 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex III MT = Malti 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex III NL = Nederlands 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex III PL = polski 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex III PT = português 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex III RO = română 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex III SK = slovenčina 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex III SL = slovenščina 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex III FI = suomi 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex III SV = svenska 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex III HR = Hrvatski 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex III IS = Islenska 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Annex III NO = Norsk 05/12/2013  
Methylphenidate Sandoz Article-29 referral - Assessment report (English only) 05/12/2013  

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 Methylphenidate Sandoz