Glimepirida Parke-Davis

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On 19 July 2012, 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 Glimepirida Parke-Davis (glimepiride, tablets 2, 3 and 4 mg). The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Glimepirida Parke-Davis outweigh its risks, and that the marketing authorisation can be granted in Portugal and in the following Member States of the EU: Cyprus, France, Germany, Italy, Sweden and the United Kingdom.

What is Glimepirida Parke-Davis?

Glimepirida Parke-Davis is a medicine used to treat type-2 diabetes (a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively).

The active substance, glimepiride, stimulates the pancreas to produce more insulin. As a result, blood glucose is reduced and this helps to control type-2 diabetes.

Glimepirida Parke-Davis is a ‘generic medicine’, which means that it is similar to a ‘reference medicine’, already authorised in the EU, called Amaryl.

Why was Glimepirida Parke-Davis reviewed?

Parke-Davis submitted an application for Glimepirida Parke-Davis (1, 2, 3 and 4 mg tablets) to the Portuguese medicines regulatory agency for a decentralised procedure. This is a procedure where one Member State (the ‘reference Member State’, in this instance Portugal) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States’, in this instance Cyprus, France, Germany, Italy, Sweden and the United Kingdom). However, the Member States were not able to reach an agreement and the Portuguese medicines agency referred the matter to the CHMP for arbitration on 31 May 2012.

The grounds for the referral were concerns over the approach used to demonstrate that Glimepirida Parke-Davis 2, 3 and 4 mg are ‘bioequivalent’ to Amaryl at the corresponding doses. Two medicines are bioequivalent when they produce the same levels of the active substance in the body. The bioequivalence study submitted by the company was carried out using 1 mg of Glimepirida Parke-Davis, and the results were applied to the higher strengths. Although the Member States agreed that 1 mg Glimepirida Parke-Davis was bioequivalent to 1 mg Amaryl, concerns remained over whether a bioequivalence study should have been carried out with the highest strength, 4 mg, to show bioequivalence for Glimepirida Parke-Davis 2, 3 and 4 mg with Amaryl at the corresponding doses.

What are the conclusions of the CHMP?

Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the bioequivalence study conducted with the 1 mg tablet is adequate to show that the higher strengths of Glimepirida Parke-Davis and Amaryl are also bioequivalent. The CHMP therefore concluded that, as Glimepirida Parke-Davis 2, 3 and 4 mg strengths are bioequivalent to the reference medicine, marketing authorisation should be granted in the concerned Member States.

The European Commission issued a decision on 19 November 2012.

Name Language First published Last updated
Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) BG = bălgarski 20/07/2012 06/12/2012
Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) ES = español 20/07/2012 06/12/2012
Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) CS = čeština 20/07/2012 06/12/2012
Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) DA = dansk 20/07/2012 06/12/2012
Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) DE = Deutsch 20/07/2012 06/12/2012
Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) ET = eesti keel 20/07/2012 06/12/2012
Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) EL = elliniká 20/07/2012 06/12/2012
Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) EN = English 20/07/2012 06/12/2012
Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) FR = français 20/07/2012 06/12/2012
Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) IT = italiano 20/07/2012 06/12/2012
Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) LV = latviešu valoda 20/07/2012 06/12/2012
Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) LT = lietuvių kalba 20/07/2012 06/12/2012
Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) HU = magyar 20/07/2012 06/12/2012
Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) MT = Malti 20/07/2012 06/12/2012
Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) NL = Nederlands 20/07/2012 06/12/2012
Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) PL = polski 20/07/2012 06/12/2012
Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) PT = português 20/07/2012 06/12/2012
Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) RO = română 20/07/2012 06/12/2012
Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) SK = slovenčina 20/07/2012 06/12/2012
Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) SL = slovenščina 20/07/2012 06/12/2012
Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) FI = suomi 20/07/2012 06/12/2012
Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) SV = svenska 20/07/2012 06/12/2012

Key facts

Approved nameGlimepirida Parke-Davis
International non-proprietary name (INN) or common name

glimepiride

Associated namesGlimepiride Pfizer, Glimepirid Pfizer, Glimepiride tablets 2 mg, Glimepiride tablets 3 mg, Glimepiride tablets 4 mg
ClassSulfonamides, urea derivatives
Reference numberEMEA/H/A-29/1338
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 date19/07/2012

All documents

Name Language First published Last updated
Glimepirida Parke Davis - Article 29(4) referral - Assessment report (English only) 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex I BG = bălgarski 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex I ES = español 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex I CS = čeština 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex I DA = dansk 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex I DE = Deutsch 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex I ET = eesti keel 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex I EL = elliniká 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex I EN = English 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex I FR = français 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex I IT = italiano 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex I LV = latviešu valoda 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex I LT = lietuvių kalba 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex I HU = magyar 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex I MT = Malti 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex I NL = Nederlands 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex I PL = polski 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex I PT = português 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex I RO = română 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex I SK = slovenčina 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex I SL = slovenščina 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex I FI = suomi 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex I SV = svenska 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex I IS = Islenska 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex I NO = Norsk 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex II BG = bălgarski 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex II ES = español 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex II CS = čeština 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex II DA = dansk 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex II DE = Deutsch 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex II ET = eesti keel 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex II EL = elliniká 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex II EN = English 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex II FR = français 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex II IT = italiano 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex II LV = latviešu valoda 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex II LT = lietuvių kalba 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex II HU = magyar 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex II MT = Malti 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex II NL = Nederlands 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex II PL = polski 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex II PT = português 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex II RO = română 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex II SK = slovenčina 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex II SL = slovenščina 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex II FI = suomi 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex II SV = svenska 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex III BG = bălgarski 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex III ES = español 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex III CS = čeština 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex III DA = dansk 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex III DE = Deutsch 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex III ET = eesti keel 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex III EL = elliniká 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex III EN = English 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex III FR = français 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex III IT = italiano 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex III LV = latviešu valoda 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex III LT = lietuvių kalba 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex III HU = magyar 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex III MT = Malti 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex III NL = Nederlands 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex III PL = polski 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex III PT = português 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex III RO = română 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex III SK = slovenčina 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex III SL = slovenščina 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex III FI = suomi 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex III SV = svenska 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex III IS = Islenska 06/12/2012  
Glimepirida Parke Davis - Article 29(4) referral - Annex III NO = Norsk 06/12/2012  
Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) BG = bălgarski 20/07/2012 06/12/2012
Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) ES = español 20/07/2012 06/12/2012
Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) CS = čeština 20/07/2012 06/12/2012
Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) DA = dansk 20/07/2012 06/12/2012
Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) DE = Deutsch 20/07/2012 06/12/2012
Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) ET = eesti keel 20/07/2012 06/12/2012
Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) EL = elliniká 20/07/2012 06/12/2012
Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) EN = English 20/07/2012 06/12/2012
Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) FR = français 20/07/2012 06/12/2012
Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) IT = italiano 20/07/2012 06/12/2012
Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) LV = latviešu valoda 20/07/2012 06/12/2012
Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) LT = lietuvių kalba 20/07/2012 06/12/2012
Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) HU = magyar 20/07/2012 06/12/2012
Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) MT = Malti 20/07/2012 06/12/2012
Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) NL = Nederlands 20/07/2012 06/12/2012
Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) PL = polski 20/07/2012 06/12/2012
Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) PT = português 20/07/2012 06/12/2012
Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) RO = română 20/07/2012 06/12/2012
Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) SK = slovenčina 20/07/2012 06/12/2012
Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) SL = slovenščina 20/07/2012 06/12/2012
Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) FI = suomi 20/07/2012 06/12/2012
Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) SV = svenska 20/07/2012 06/12/2012

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 Glimepirida Parke-Davis