Trobalt

RSS
Withdrawn

This medicine's authorisation has been withdrawn

retigabine
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

The marketing authorisation for Trobalt has been withdrawn at the request of the marketing-authorisation holder.

Trobalt : EPAR - Summary for the public

English (EN) (509.85 KB - PDF)

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български (BG) (602.21 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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español (ES) (570.89 KB - PDF)

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čeština (CS) (588.03 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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dansk (DA) (571.77 KB - PDF)

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Deutsch (DE) (566.87 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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eesti keel (ET) (568.93 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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ελληνικά (EL) (663.17 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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français (FR) (571.85 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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hrvatski (HR) (563.56 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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italiano (IT) (576.81 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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latviešu valoda (LV) (596.81 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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lietuvių kalba (LT) (571.43 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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magyar (HU) (586.13 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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Malti (MT) (579.27 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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Nederlands (NL) (570.47 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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polski (PL) (587.24 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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português (PT) (572.32 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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română (RO) (570.88 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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slovenčina (SK) (600.73 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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slovenščina (SL) (593.62 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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Suomi (FI) (568.59 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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svenska (SV) (569.68 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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Product information

Trobalt : EPAR - Product Information

English (EN) (884.22 KB - PDF)

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български (BG) (1.4 MB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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español (ES) (892.69 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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čeština (CS) (1.39 MB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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dansk (DA) (1020.94 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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Deutsch (DE) (1.38 MB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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eesti keel (ET) (1 MB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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ελληνικά (EL) (1.55 MB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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français (FR) (916.28 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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hrvatski (HR) (1.11 MB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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íslenska (IS) (1.14 MB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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italiano (IT) (1.01 MB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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latviešu valoda (LV) (1.29 MB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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lietuvių kalba (LT) (1.23 MB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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magyar (HU) (1.36 MB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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Malti (MT) (1.45 MB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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Nederlands (NL) (1.05 MB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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norsk (NO) (991.35 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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polski (PL) (1.47 MB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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português (PT) (1.03 MB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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română (RO) (1.35 MB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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slovenčina (SK) (1.34 MB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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slovenščina (SL) (1.29 MB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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Suomi (FI) (981.88 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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svenska (SV) (1.02 MB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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Latest procedure affecting product information: IAIN/0043
19/07/2018
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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

 

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Trobalt : EPAR - All Authorised presentations

English (EN) (478.11 KB - PDF)

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български (BG) (497.89 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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español (ES) (484.24 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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čeština (CS) (491.97 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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dansk (DA) (478.19 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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Deutsch (DE) (478.46 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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eesti keel (ET) (477.69 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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ελληνικά (EL) (496.42 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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français (FR) (478.17 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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hrvatski (HR) (477.95 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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íslenska (IS) (478.89 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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italiano (IT) (478.36 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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latviešu valoda (LV) (489.94 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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lietuvių kalba (LT) (479.38 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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magyar (HU) (488.87 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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Malti (MT) (490.51 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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Nederlands (NL) (476.61 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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norsk (NO) (478.89 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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polski (PL) (489.77 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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português (PT) (477.16 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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română (RO) (477.35 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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slovenčina (SK) (490.23 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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slovenščina (SL) (489.58 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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Suomi (FI) (476.51 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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svenska (SV) (464.35 KB - PDF)

First published: 05/04/2011Last updated: 19/11/2018
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Product details

Name of medicine
Trobalt
Active substance
retigabine
International non-proprietary name (INN) or common name
retigabine
Therapeutic area (MeSH)
Epilepsy
Anatomical therapeutic chemical (ATC) code
N03AX21

Pharmacotherapeutic group

Antiepileptics

Therapeutic indication

Trobalt is indicated as adjunctive treatment of drug-resistant partial-onset seizures with or without secondary generalisation in patients aged 18 years or older with epilepsy, where other appropriate drug combinations have proved inadequate or have not been tolerated.

Authorisation details

EMA product number
EMEA/H/C/001245
Marketing authorisation holder
Glaxo Group Limited 

Glaxo Group Limited
980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom

Marketing authorisation issued
27/03/2011
Revision
12

Assessment history

Trobalt : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (582.83 KB - PDF)

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Trobalt-H-C-1245-II-0014 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/CHMP/59744/2013

English (EN) (591.14 KB - PDF)

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Trobalt : EPAR - Public assessment report

AdoptedReference Number: EMA/CHMP/207154/2011

English (EN) (1.35 MB - PDF)

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CHMP summary of positive opinion for Trobalt

AdoptedReference Number: EMA/31145/2011

English (EN) (550.21 KB - PDF)

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Related content

Public statement on Trobalt: Withdrawal of the marketing authorisation in the European Union

Reference Number: EMA/759832/2018

English (EN) (58.76 KB - PDF)

First published:
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