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

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

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