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Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Methylthioninium chloride Proveblue   

   This product is authorized under a different brandname in the EU in the folowing languages:
   - Methylthioniniumchlorid Proveblue (CS)
   - Methylthioniniumchlorid Proveblue (DA)
   - Methylthioniniumchlorid Proveblue (DE)
   - Cloruro de metiltioninio Proveblue (ES)
   - Chlorure de méthylthioninium Proveblue (FR)
   - Metiltioninio cloruro Proveblue (IT)
   - Metiltioninio chloridas Proveblue (LT)
   - Cloreto de metiltionina Proveblue (PT)
   - Clorură de metiltioniniu Proveblue (RO)
Auth. number : EU/1/11/682
INN : methylthioninium chloride
ATC: Anatomical main group: V - Various
Therapeutic subgroup: V03 - All other therapeutic products
Pharmacological subgroup: V03A - All other therapeutic products
Chemical subgroup: V03AB - Antidotes
Chemical substance: V03AB17 - Methylthionine
(See WHO ATC Index)
Indication: Acute symptomatic treatment of medicinal and chemical products- induced methaemoglobinaemia. Methylthioninium chloride Proveblue is indicated in adults, children and adolescents (aged 0 to 17 years old).
Marketing Authorisation Holder: Provepharm S.A.S.
22 Rue Marc Donadille, 13013 Marseille, France

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
12/05/2011 Centralised - Authorisation EMEA/H/C/2108 (2011)3239 of 06/05/2011
23/09/2011 Centralised - Notification EMEA/H/C/2108/N/1
Updated with Decision(2012)6162 of 30/08/2012
07/02/2012 Centralised - Variation EMEA/H/C/2108/IB/3
Updated with Decision(2012)6162 of 30/08/2012
05/07/2012 Centralised - Variation EMEA/H/C/2108/IB/4/G
Updated with Decision(2012)6162 of 30/08/2012
04/09/2012 Centralised - Variation (2012)6162 of 30/08/2012
05/12/2012 Centralised - Notification EMEA/H/C/2108/N/5
Updated with Decision(2014)10086 of 16/12/2014
22/10/2013 Centralised - Notification EMEA/H/C/2108/N/6
Updated with Decision(2014)10086 of 16/12/2014
26/11/2013 Centralised - Variation EMEA/H/C/2108/IB/7/G
Updated with Decision(2014)10086 of 16/12/2014
17/01/2014 Centralised - Variation EMEA/H/C/2108/IAin/11
Updated with Decision(2014)10086 of 16/12/2014
04/08/2014 Centralised - Variation EMEA/H/C/2108/IAin/18
Updated with Decision(2014)10086 of 16/12/2014
25/09/2014 Centralised - Variation EMEA/H/C/2108/II/14
Updated with Decision(2014)10086 of 16/12/2014
25/09/2014 Centralised - Variation EMEA/H/C/2108/II/15
Updated with Decision(2014)10086 of 16/12/2014