Panretin
Withdrawn
This medicine's authorisation has been withdrawn
alitretinoin
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
The marketing authorisation for Panretin has been withdrawn at the request of the marketing-authorisation holder.
Panretin : EPAR - Medicine overview
English (EN) (637.1 KB - PDF)
First published: Last updated:
български (BG) (706 KB - PDF)
First published: 29/05/2007Last updated: 02/07/2018
español (ES) (636.14 KB - PDF)
First published: 29/05/2007Last updated: 02/07/2018
čeština (CS) (690.6 KB - PDF)
First published: 29/05/2007Last updated: 02/07/2018
dansk (DA) (635.31 KB - PDF)
First published: 29/05/2007Last updated: 02/07/2018
Deutsch (DE) (635.69 KB - PDF)
First published: 29/05/2007Last updated: 02/07/2018
eesti keel (ET) (634.79 KB - PDF)
First published: 29/05/2007Last updated: 02/07/2018
ελληνικά (EL) (714.41 KB - PDF)
First published: 29/05/2007Last updated: 02/07/2018
français (FR) (636.79 KB - PDF)
First published: 29/05/2007Last updated: 02/07/2018
hrvatski (HR) (654.05 KB - PDF)
First published: 29/05/2007Last updated: 02/07/2018
italiano (IT) (635.67 KB - PDF)
First published: 29/05/2007Last updated: 02/07/2018
latviešu valoda (LV) (697.88 KB - PDF)
First published: 29/05/2007Last updated: 02/07/2018
lietuvių kalba (LT) (657.7 KB - PDF)
First published: 29/05/2007Last updated: 02/07/2018
magyar (HU) (685.93 KB - PDF)
First published: 29/05/2007Last updated: 02/07/2018
Malti (MT) (690.48 KB - PDF)
First published: 29/05/2007Last updated: 02/07/2018
Nederlands (NL) (636.07 KB - PDF)
First published: 29/05/2007Last updated: 02/07/2018
polski (PL) (690.71 KB - PDF)
First published: 29/05/2007Last updated: 02/07/2018
português (PT) (636.13 KB - PDF)
First published: 29/05/2007Last updated: 02/07/2018
română (RO) (663.54 KB - PDF)
First published: 29/05/2007Last updated: 02/07/2018
slovenčina (SK) (689.91 KB - PDF)
First published: 29/05/2007Last updated: 02/07/2018
slovenščina (SL) (680.88 KB - PDF)
First published: 29/05/2007Last updated: 02/07/2018
Suomi (FI) (635.37 KB - PDF)
First published: 29/05/2007Last updated: 02/07/2018
svenska (SV) (636.02 KB - PDF)
First published: 29/05/2007Last updated: 02/07/2018
Product information
Panretin : EPAR - Product Information
English (EN) (770.77 KB - PDF)
First published: Last updated:
български (BG) (1.36 MB - PDF)
First published: 17/04/2009Last updated: 10/04/2019
español (ES) (775.45 KB - PDF)
First published: 17/04/2009Last updated: 10/04/2019
čeština (CS) (1.15 MB - PDF)
First published: 17/04/2009Last updated: 10/04/2019
dansk (DA) (816.4 KB - PDF)
First published: 17/04/2009Last updated: 10/04/2019
Deutsch (DE) (758.96 KB - PDF)
First published: 17/04/2009Last updated: 10/04/2019
eesti keel (ET) (768.31 KB - PDF)
First published: 17/04/2009Last updated: 10/04/2019
ελληνικά (EL) (1.34 MB - PDF)
First published: 17/04/2009Last updated: 10/04/2019
français (FR) (780.97 KB - PDF)
First published: 17/04/2009Last updated: 10/04/2019
hrvatski (HR) (781.51 KB - PDF)
First published: 17/04/2009Last updated: 10/04/2019
íslenska (IS) (780.49 KB - PDF)
First published: 17/04/2009Last updated: 10/04/2019
italiano (IT) (773.44 KB - PDF)
First published: 17/04/2009Last updated: 10/04/2019
latviešu valoda (LV) (1.15 MB - PDF)
First published: 17/04/2009Last updated: 10/04/2019
lietuvių kalba (LT) (773.63 KB - PDF)
First published: 17/04/2009Last updated: 10/04/2019
magyar (HU) (1.12 MB - PDF)
First published: 17/04/2009Last updated: 10/04/2019
Malti (MT) (1.18 MB - PDF)
First published: 17/04/2009Last updated: 10/04/2019
Nederlands (NL) (782.84 KB - PDF)
First published: 17/04/2009Last updated: 10/04/2019
norsk (NO) (772.79 KB - PDF)
First published: 17/04/2009Last updated: 10/04/2019
polski (PL) (1.15 MB - PDF)
First published: 17/04/2009Last updated: 10/04/2019
português (PT) (781.79 KB - PDF)
First published: 17/04/2009Last updated: 10/04/2019
română (RO) (781.34 KB - PDF)
First published: 17/04/2009Last updated: 10/04/2019
slovenčina (SK) (1.14 MB - PDF)
First published: 17/04/2009Last updated: 10/04/2019
slovenščina (SL) (1.12 MB - PDF)
First published: 17/04/2009Last updated: 10/04/2019
Suomi (FI) (771.46 KB - PDF)
First published: 17/04/2009Last updated: 10/04/2019
svenska (SV) (774.04 KB - PDF)
First published: 17/04/2009Last updated: 10/04/2019
Latest procedure affecting product information:
IAIN/0045
24/01/2019
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).
Panretin : EPAR - All Authorised presentations
English (EN) (620.96 KB - PDF)
First published: Last updated:
български (BG) (670.87 KB - PDF)
First published: 26/01/2006Last updated: 26/01/2006
español (ES) (621.3 KB - PDF)
First published: 26/01/2006Last updated: 26/01/2006
čeština (CS) (650.02 KB - PDF)
First published: 26/01/2006Last updated: 26/01/2006
dansk (DA) (622.59 KB - PDF)
First published: 26/01/2006Last updated: 26/01/2006
Deutsch (DE) (620.46 KB - PDF)
First published: 26/01/2006Last updated: 26/01/2006
eesti keel (ET) (621.29 KB - PDF)
First published: 26/01/2006Last updated: 26/01/2006
ελληνικά (EL) (661.55 KB - PDF)
First published: 26/01/2006Last updated: 26/01/2006
français (FR) (620.86 KB - PDF)
First published: 26/01/2006Last updated: 26/01/2006
italiano (IT) (619.92 KB - PDF)
First published: 26/01/2006Last updated: 26/01/2006
latviešu valoda (LV) (658.79 KB - PDF)
First published: 26/01/2006Last updated: 26/01/2006
lietuvių kalba (LT) (640.83 KB - PDF)
First published: 26/01/2006Last updated: 26/01/2006
magyar (HU) (657.79 KB - PDF)
First published: 26/01/2006Last updated: 26/01/2006
Malti (MT) (662.45 KB - PDF)
First published: 26/01/2006Last updated: 26/01/2006
Nederlands (NL) (620.27 KB - PDF)
First published: 26/01/2006Last updated: 26/01/2006
polski (PL) (660.55 KB - PDF)
First published: 26/01/2006Last updated: 26/01/2006
português (PT) (621.46 KB - PDF)
First published: 26/01/2006Last updated: 26/01/2006
română (RO) (637.34 KB - PDF)
First published: 26/01/2006Last updated: 26/01/2006
slovenčina (SK) (650.02 KB - PDF)
First published: 26/01/2006Last updated: 26/01/2006
slovenščina (SL) (645.35 KB - PDF)
First published: 26/01/2006Last updated: 26/01/2006
Suomi (FI) (619.4 KB - PDF)
First published: 26/01/2006Last updated: 26/01/2006
svenska (SV) (628.43 KB - PDF)
First published: 26/01/2006Last updated: 26/01/2006
Product details
- Name of medicine
- Panretin
- Active substance
- alitretinoin
- International non-proprietary name (INN) or common name
- alitretinoin
- Therapeutic area (MeSH)
- Sarcoma, Kaposi
- Anatomical therapeutic chemical (ATC) code
- L01XX22
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
Panretin gel is indicated for the topical treatment of cutaneous lesions in patients with acquired-immune-deficiency-syndrome (AIDS)-related Kaposi's sarcoma (KS) when:
- lesions are not ulcerated or lymphoedematous, and;
- treatment of visceral KS is not required, and;
- lesions are not responding to systemic antiretroviral therapy, and;
- radiotherapy or chemotherapy are not appropriate.
Authorisation details
- EMA product number
- EMEA/H/C/000279
- Marketing authorisation holder
- Eisai GmbH
Eisai GmbH
Edmund-Rumpler-Strasse 3
60549 Frankfurt am Main
Germany - Marketing authorisation issued
- 11/10/2000
- Revision
- 17
Assessment history
Panretin : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (634.61 KB - PDF)
First published: Last updated:
Panretin : EPAR - Divergent position(s) - Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data
English (EN) (592.54 KB - PDF)
First published: Last updated:
Panretin-H-A-31-1446-C-000279-0037 : EPAR - Assessment Report
AdoptedReference Number: EMA/254364/2018
English (EN) (846.85 KB - PDF)
First published: Last updated:
Panretin : EPAR - Steps taken after authorisation when a cutoff date has been used
English (EN) (648.81 KB - PDF)
First published: Last updated:
More information on Panretin
Public statement on Panretin: Withdrawal of the marketing authorisation in the European Union
Reference Number: EMA/652257/2020
English (EN) (118.8 KB - PDF)
First published:
More information on Panretin
Topics
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