European Medicines Agency - Human Medicines - CHMP Summaries of Opinion

Human Medicines - CHMP Summaries of Opinion

Substance/INN or Common name / Human Medicines - CHMP Summaries of Opinion

Substance/INN or Common name - Invented Name - Opinion - Adoption - Date

- tocofersolan: Vedrop 29/05/09
- clopidogrel: Clopidogrel Teva 29/05/09
- topotecan: Topotecan Actavis 29/05/09
- clopidogrel: Grepid 29/05/09
- clopidogrel: Clopidogrel Hexal 29/05/09
- plerixafor: Mozobil 29/05/09
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Prepandemic influenza vaccine (H5N1): (split virion, inactivated, adjuvanted) A/VietNam/1194/2004 NIBRG-14* Prepandrix 29/05/09
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Prepandemic influenza vaccine (H5N1): (split virion, inactivated, adjuvanted) A/VietNam/1194/2004 NIBRG-14* PrepandemicInfluenza Vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 29/05/09
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- sildenafil*: Revatio 29/05/09
- tolvaptan: Samsca 29/05/09
- clopidogrel: Clopidogrel Ratiopharm GMBH 29/05/09
- clopidogrel: Clopidogrel 1A Pharma 29/05/09
- clopidogrel: Clopidogrel Acino 29/05/09
- pemetrexed*: Alimta 29/05/09
- everolimus: Afinitor 29/05/09
- sitagliptin phosphate monohydrate / metformin hydrochloride*: Velmetia 23/04/09
- sitagliptin*: Tesavel 23/04/09
- sitagliptin*: Xelevia 23/04/09
- sitagliptin phosphate monohydrate / metformin hydrochloride*: Efficib 23/04/09
- tipranavir*: Aptivus (children aged 2 - 12 years) 23/04/09
- tipranavir*: Aptivus (12 years of age or older) 23/04/09
- sitagliptin phosphate monohydrate / metformin hydrochloride*: Janumet 23/04/09
- sitagliptin*: Januvia 23/04/09
- repaglinide: Repaglinide teva 23/04/09 corr 27/04/09
- darunavir*: Prezista 23/04/09
- gefinitib: Iressa 23/04/09
- ribavirin: Ribavirin teva pharma BV 23/04/09
- caffeine: Nymusa 23/04/09
- liraglutide: Victoza 23/04/09
- pregabalin: Questions and answers for Lyrica 23/04/09 Negative
- fentanyl: Instanyl 23/04/09
- aztreonam: Questions and answers for Cayston 19/03/09 Negative
- imatinib*: Glivec 19/03/09
- rivastigmine: Nimvastid 19/03/09
- capsaicin: Qutenza 19/03/09
- tacrolimus: Modigraf 19/03/09
- ulipristal: acetate Ellaone 19/03/09
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pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) A/Vietnam/1194/2004 (NIBRG-14) Questions and answers for Emerflu 19/03/09 Negative
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- sevelamer (carbonate): Renvela 19/03/09
- pantoprazole: Controloc Control 19/02/09
- pantoprazole: Pantoloc Control 19/02/09
- pantoprazole: Somac Control 19/02/09
- pantoprazole: Pantecta Control 19/02/09
- interferon beta-1a: Questions and Answers for Biferonex 19/02/09 Negative
- pantoprazole: Pantozol Control 19/02/09
- tocofersolan: Questions and Answers for Vedrop 22/01/09 Negative
- tacrolimus*: Protopic 22/01/09
- idebenone: Corr. 1 Questions & Answers for Sovrima 20/11/08 Negative
- ceftobiprole: medocaril Zevtera 20/11/08
- xabepilone: Questions & Answers for Ixempra 20/11/08 Negative
- duloxetine: Questions & Answers for Cymbalta/Xeristar 23/10/08 Negative
- eszopiclone: Lunivia 23/10/08
- eptotermin alfa: Question & Answers for Opgenra 23/10/08
- idebenone: Questions & Answers for Sovrima 24/07/08 Negative
- docetaxel: Questions & Answers for Taxotere/Docetaxel Winthrop 24/07/08 Negative
- histamine dihydrochloride: Question & Answers for Ceplene 24/07/08
- eptotermin alfa: Questions & Answers for Opgenra 26/06/08 Negative
- ramelteon: Questions & Answers for Ramelteon 02/06/08 Negative
- lenalidomide: Questions & Answers for Lenalidomide Celgene Europe 02/06/08 Negative
- certolizumab pegol: Questions & Answers for Cimzia 19/03/08 Negative
- recombinant human C1 inhibitor: Questions & Answers for Rhucin 19/03/08 Negative
- thalidomide: Questions & Answers for Thalidomide Pharmion 24/01/08
- lenalidomide: Questions & Answers for Lenalidomide Celgene Europe 24/01/08 Negative
- gemtuzumab ozogamicin: Questions & Answers for Mylotarg 24/01/08 Negative
- eprodisate disodium Questions & Answers for Mylotarg 13/12/07 Negative
- certolizumab pegol: Questions & Answers for Cimzia 15/11/07 Negative
- natalizumab: Questions & Answers for Natalizumab Elan Pharma 15/11/07 Negative
- miglustat: Questions & Answers for Zavesca 18/10/07 Negative
- gemtuzumab ozogamicin: Questions & Answers or Mylotarg 21/09/07 Negative
- somatropin: Questions & Answers for Nutropinaq 21/09/07 Negative
- natalizumab: Questions & Answers for Natalizumab 19/07/07 Negative
- adenovirus-mediated Herpes simplex virus-thymidine kinase gene: Questions & Answers for Cerepro 27/04/07 Negative
- Trabectedin: Yondelis 21/11/03 Negative
- Somatropin: Serostim 03/09/03 Negative
- Somatropin: Omnitrop 26/06/03
- Cevimeline: Evoxac 26/04/01 Negative
- Propentof`ylline - Propentofylline - Kronos Viviq 24/03/99 Negative
- Saruplase: Rescupase 25/03/99 Negative

* Post-authorisation opinions

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European Medicines Agency - Human Medicines - CHMP Summaries of Opinion