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- Clopidogrel Sandoz
Community Register of medicinal products
Community list of not active medicinal products for human use |
WITHDRAWN |
Product information |
| Invented name: | Clopidogrel Sandoz |
| Auth. number : | EU/1/09/547 |
| INN : | Clopidogrel |
| ATC: | B - Blood and blood forming organs B01 - Antithrombotic agents B01A - Antithrombotic agents B01AC - Platelet aggregation inhibitors excluding Heparin B01AC04 - Clopidogrel (See WHO ATC Index) |
| Indication: | Clopidogrel is indicated in adults for the prevention of atherothrombotic events in patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. |
| Marketing Authorisation Holder: | Acino Pharma GmbH
Am Windfeld 35, D-83714 Miesbach, Deutschland |
EPAR and active package presentations
Package presentations
|
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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 continues to be available in the Community Register. |
European Commission procedures
| Close date procedure | Procedure type | EMEA number | Decision | summary publ | decision docs | annex |
| 23/09/2009 | Centralised - Authorisation | EMEA/H/C/1174 | (2009)7409 of 21/09/2009 | |||
| 14/10/2009 | Centralised - Variation | EMEA/H/C/1174/IA/3 | ||||
| Updated with Decision(2010)2012 of 23/03/2010 | ||||||
| 16/10/2009 | Centralised - Variation | EMEA/H/C/1174/IA/2 | ||||
| 16/10/2009 | Centralised - Variation | EMEA/H/C/1174/IA/1 | ||||
| 09/02/2010 | Centralised - Variation | EMEA/H/C/1174/IA/6 | ||||
| 12/02/2010 | Centralised - Variation | EMEA/H/C/1174/II/5 | ||||
| 12/02/2010 | Centralised - Variation | EMEA/H/C/1174/II/4 | ||||
| 25/03/2010 | Centralised - Variation | - | (2010)2012 of 23/03/2010 | |||
| 30/03/2010 | Referral | EMEA/H/C/1174/A-20/7 | (2010)2206 of 29/03/2010 | |||
| 14/05/2010 | Centralised - Variation | EMEA/H/C/1174/IA/8 | ||||
| 08/06/2010 | Centralised - Variation | EMEA/H/C/1174/N/9 | ||||
| Updated with Decision(2011)1881 of 17/03/2011 | ||||||
| 28/06/2010 | Corrigendum | - | (2010)2206 corr of 24/06/2010 | |||
| 06/08/2010 | Centralised - Variation | EMEA/H/C/1174/IB/10 | ||||
| Updated with Decision(2011)1881 of 17/03/2011 | ||||||
| 20/09/2010 | Referral | - | (2010)6433 of 16/09/2010 | |||
| 17/11/2010 | Centralised - Variation | EMEA/H/C/1174/WS/53 | ||||
| 08/12/2010 | Centralised - Variation | EMEA/H/C/1174/WS/52 | ||||
| 22/03/2011 | Centralised - Variation | - | (2011)1881 of 17/03/2011 | |||
| 04/04/2011 | Centralised - Withdrawal | - | (2011)2423 of 31/03/2011 |