CHMP recommendation

Related by string. * : CHMP . Human Use CHMP . CHMP opinion . CHMP Opinion / recommen dations . Recommendations . recommendations . Recommendation . RECOMMENDATION . RECOMMENDATIONS : SmarTrend Sell Recommendation . term Neutral recommendation . Castle Braai recommendations . SmarTrend Buy Recommendation . Neutral recommendation . Solicitation Recommendation Statement * *

Related by context. All words. (Click for frequent words.) 75 CHMP opinion 70 MAA submission 70 Trobalt 70 CHMP 69 orphan designation 69 TEMODAL 69 Marketing Authorization 68 OMP designation 68 SEBIVO 67 CONBRIZA 67 Centralized Procedure 67 Biologics Licensing 67 Retacrit 67 SYCREST 67 Marketing Authorisation 67 Nebido 67 NEBIDO 66 Adenuric R 66 Preotact 66 BLA filing 66 Xyrem ® 66 Toctino R 66 Thalidomide Pharmion 66 Dacogen injection 66 orphan medicinal product 66 Decentralized Procedure 66 Raptiva R 65 Ruconest 65 SUMAVEL DosePro 65 Sycrest 65 Vernakalant 65 Marketing Authorisation Application 65 FIRAZYR 65 Orphan Medicinal Product 65 Certican 65 IRESSA 65 FDA approvable letter 65 Mutual Recognition Procedure 65 CryoSeal FS System 65 AZILECT ® 65 Zenpep 64 FIRMAGON R 64 Toctino ® 64 Evoltra 64 Orathecin 64 Toctino ® alitretinoin 64 Febuxostat 64 Marketing Authorization Application 64 Serdolect ® 64 Soliris TM eculizumab 64 Cladribine 64 SUTENT ® 64 BLA submission 64 Oracea ® 64 Medicinal Products EMEA 64 Removab 64 Egrifta 64 Plicera 64 liver resection surgeries 64 Marketing Authorization Applications 63 Orphan Status 63 Tyverb 63 Emezine 63 Mepact 63 Auxilium Pharma 63 WILEX 63 Zolpimist 63 Teysuno 63 Sebivo 63 Photocure 63 Cellegesic 63 European Medicines Evaluation 63 XIAPEX 63 GTC recombinant form 63 ezogabine 63 Advagraf 63 Rhucin ® 63 Focetria 63 Nabi HB Intravenous 63 Rasilez HCT 63 Alvesco R 63 Orphan Drug status 63 Loramyc 63 Firazyr 63 Raptiva ® 63 Esbriet pirfenidone 63 Orphan Designation 63 RoActemra 63 Flutiform TM 63 Telzir 63 Velcade bortezomib 63 Peginterferon alfa 2b 62 Preotact R 62 Torisel 62 Sumavel DosePro 62 Onsolis 62 Neupro R 62 Angiox 62 Ranolazine 62 Plenaxis R 62 Aryplase 62 Junovan 62 Voraxaze 62 Lambert Eaton Myasthenic 62 Somatuline R Autogel R 62 Mimpara 62 Gamunex C 62 YONDELIS 62 SNT MC# 62 Ilaris 62 Marketing Authorisation Application MAA 62 Marketing Authorization Application MAA 62 Rhucin R 62 Solasia 62 CELVAPAN H#N# 62 approvable letters 62 Nivestim 62 Zalbin 62 Loramyc R 62 Romiplostim 62 Evoltra TM 62 Onrigin 62 REBETOL combination therapy 62 Tracleer r 62 Civacir 62 Orphan designation 62 Swissmedic 62 Increlex R 62 MEPACT 62 FRDA 62 OMAPRO ™ 62 Revolade 62 Cimzia ® certolizumab pegol 62 Zavesca r 62 Plenaxis TM 62 pancreatic enzyme replacement 62 Multiferon R 61 Stavzor 61 MAGE A3 ASCI 61 PROMACTA 61 XIAFLEX ™ 61 Angiox ® 61 Risperidone Oral Solution 61 Kynapid 61 Zebinix R 61 Esbriet ® 61 Final Appraisal Determination 61 SILENOR 61 Tostrex 61 NOXAFIL 61 Avastin bevacizumab 61 Hexvix 61 ORTHOVISC mini 61 Omnitrope 61 subcutaneous formulation 61 CIP TRAMADOL ER 61 Esbriet 61 Forsteo 61 Relistor 61 EGRIFTA ™ 61 Zingo TM 61 Sanvar R 61 Pennsaid R 61 Orazol 61 alvimopan 61 Cancidas 61 TroVax ® 61 #D#C# 61 balsalazide tablet 61 Santhera 61 Hycamtin 61 rotigotine transdermal patch 61 BRILINTA 61 Abstral 61 RhuDex 61 Frova ® 61 methylnaltrexone 61 AERx iDMS 61 LUVENIQ 61 Aviptadil 61 Ceplene R 61 Clevudine 61 Joulferon 61 Vimpat ® lacosamide 61 Application MAA 61 FDA Advisory Panel 61 phase IIb trial 61 Receives Marketing Authorization 61 Allovectin 7 ® 61 Arranon 61 BiDil XR 60 Pegintron 60 desvenlafaxine 60 Extavia 60 injectable formulations 60 Vertex hepatitis C 60 Premarket Approval 60 ZOLINZA 60 Ruconest ™ 60 Firdapse ™ amifampridine phosphate 60 Nexavar sorafenib 60 cinacalcet HCl 60 octreotide implant 60 Biologic License Application BLA 60 Application BLA 60 ONSOLIS 60 CDP# 60 Sanctura XR 60 Orphan Drug designation 60 Evoltra ® 60 Vasovist 60 AZILECT R 60 Fast Track Status 60 SCHWARZ PHARMA 60 Loramyc ® 60 Seroquel XR 60 PREOS 60 EOquin 60 Saforis 60 sublingual tablets 60 severe hypercholesterolemia 60 IMA# 60 Oncologic Drugs Advisory 60 OPAXIO 60 CAELYX 60 Movectro 60 PREOS R 60 ELIQUIS 60 Abstral ® 60 Exforge HCT 60 NESINA 60 SmPC 60 paliperidone palmitate 60 PDUFA Date 60 EDQM 60 Japanese Encephalitis vaccine 60 Mycograb 60 Ocrelizumab 60 FDA Approvable Letter 60 pitavastatin 60 FACTIVE R gemifloxacin 60 Eligard ® 60 Omapro 60 Votrient 60 Orexo 60 Reclast Aclasta 60 Pirfenidone 60 Noxafil 60 hoFH 60 COMFORT II 60 Firazyr ® 60 Icatibant 60 oral ridaforolimus 60 Orapred ODT 60 XEPLION ® 60 Angiox R 60 ACOMPLIA R 60 histamine dihydrochloride 60 Proprietary Medicinal Products CPMP 60 Tasigna nilotinib 60 Vimpat R 60 Actimmune ® 60 dalbavancin 60 Syndrome LEMS 60 octreotide acetate 60 levocetirizine 60 vinflunine 60 sNDA submission 60 Allovectin 7 60 Glybera R 60 Orphan Drug Designation 60 Xinlay 60 Tarceva TM 60 Lodotra 60 telavancin NDA 60 Eliquis 60 Rhucin 60 AMITIZA R 60 nasal calcitonin product 60 PhotoCure 60 Neupro 60 BEMA Granisetron 60 oxymorphone ER 60 Increlex ® 60 lasofoxifene 60 Dr. McHutchison 60 OvaRex ® MAb 60 Emselex 59 successfully commercialize Iluvien 59 ECVAM 59 Zytiga 59 amifampridine phosphate 59 Lubiprostone 59 PDE4 inhibitor 59 Drug Eluting Stent System 59 RAPTIVA 59 herpetic keratitis 59 Orphan Drug Status 59 Teflaro 59 Aflunov 59 PrevOnco ™ 59 VPRIV 59 Brilique 59 granted Ortec 59 Ilaris ® 59 markets HP Acthar 59 Fortical R 59 PhosLo 59 orphan medicinal 59 T Pred 59 Vandetanib 59 Syncria 59 GEM #S 59 Telatinib 59 BioAlliance 59 ONGLYZA ™ 59 Vectibix panitumumab 59 supplemental biologics 59 Rectogesic 59 Proquin XR 59 ARIXTRA R 59 Ceplene 59 Dyloject TM 59 Basilea Toctino R 59 generation purine nucleoside 59 Kepivance 59 GTC recombinant human 59 Somatuline Depot 59 ruxolitinib 59 Thyrogen 59 Adenuric ® 59 SCENESSE ® 59 PrandiMet 59 Silodosin 59 Linjeta 59 Clinuvel 59 SIR Spheres 59 Zirgan 59 Pazopanib 59 Iluvien ® 59 Keppra ® levetiracetam 59 Fludara ® 59 Entocort 59 Hexvix ® 59 Canvaxin 59 Adenuric 59 human antithrombin 59 received CE Conformite 59 Velac 59 Degarelix 59 Human Medicinal Products 59 Fentanyl TAIFUN R 59 Fast Track Designation 59 velaglucerase alfa 59 Targretin capsules 59 efalizumab 59 IND submission 59 Elestrin TM 59 ZADAXIN ® 59 TWYNSTA ® 59 Mycamine 59 LO LOESTRIN FE 59 Ixempra 59 Saphris 59 Uplyso 59 GATTEX TM 59 Ciclesonide 59 Victoza liraglutide 59 Naglazyme 59 Exelon Patch 59 testosterone gel LibiGel 59 BioDelivery Sciences 59 Alair System 59 PRIALT 59 omacetaxine mepesuccinate 59 European Medicines Agency 59 mesylate tablets 59 liprotamase 59 tramiprosate ALZHEMED TM 59 Rasilamlo 59 Cefprozil 59 ARCOXIA 59 Liprotamase 59 registrational 58 Fusilev 58 Arzerra ofatumumab 58 Yondelis ® 58 Loramyc ™ 58 Dabigatran etexilate 58 Mircera 58 Dalbavancin 58 Zavesca 58 Pre IND 58 Sprycel dasatinib 58 Orphan Medicinal Products 58 Product Characteristics 58 vernakalant 58 oral salmon calcitonin 58 THELIN 58 Fast Track designations 58 Pliaglis 58 Dacogen TM 58 DIFICID ™ 58 Nimotuzumab 58 rilonacept 58 Aclasta Reclast 58 MEZAVANT 58 Evoltra R 58 Dendreon Provenge 58 fesoterodine 58 Resolor 58 Tekturna HCT 58 Ozurdex 58 DORIBAX 58 PREFLUCEL 58 Tezampanel 58 Nuedexta 58 Treximet 58 Cimzia R 58 zileuton CR 58 Onco TCS 58 TheraCIM 58 Argatroban 58 Onbrez Breezhaler 58 MethyPatch 58 Fortigel 58 FOSRENOL 58 Veregen ® 58 Brinavess 58 ULTRASE 58 Kuvan 58 Viviant 58 Pixuvri 58 synthetic lipoglycopeptide antibiotic 58 Receives Positive Opinion 58 Anturol TM 58 Privigen 58 HFA MDI 58 HuMax CD4 58 OLEPTRO 58 ELAPRASE 58 CPMP 58 Ranexa R 58 Levoleucovorin 58 eprodisate Fibrillex TM 58 oral methylnaltrexone 58 faropenem 58 MERREM 58 Veregen TM 58 Rasagiline 58 Elan NanoCrystal 58 Orencia abatacept 58 Bifeprunox 58 CRMD# 58 DRAXIMAGE 58 oropharyngeal candidiasis 58 Positive Opinion 58 GLP toxicology studies 58 Fampyra 58 Aloxi R 58 Replagal 58 Campath alemtuzumab 58 Arikace 58 Alvesco ® 58 Alitretinoin 58 XIAPEX ® 58 Lovaza TM 58 Ceflatonin 58 NOMAC E2 58 ADVEXIN p# therapy 58 Soriatane 58 capsule formulation 58 oral iron chelator 58 Betaferon ® 58 SPIRIVA HandiHaler 58 Regeneron Pharma 58 CIP Fenofibrate 58 FOLOTYN ® 58 ATPace TM 58 Tredaptive 58 registrational studies 58 CIMZIA r 58 Nippon Shinyaku 58 VIVITROL ® 58 Kiadis Pharma 58 albinterferon alfa 2b 58 Troxatyl 58 Phase Ib study 58 SUMAVEL 58 Fibrillex TM 58 Imvamune 58 Alvesco 58 bazedoxifene 58 trabectedin 58 Rotarix R 58 BLP# Liposome Vaccine 58 adenosine injection 58 Troxatyl TM 58 Amigal 58 PMA submission 58 gepirone ER 58 Darunavir 58 Kuvan R 58 Taxotere ® 58 Vidaza azacitidine 58 Metformin GR 58 Herceptin trastuzumab 58 LEUKINE 58 NVA# 58 Aridol 58 Soliris eculizumab 58 RANK Ligand inhibitor 58 YONDELIS R 58 Belimumab 58 interferon gamma 1b 58 RECOTHROM R 58 REMINYL ® 58 Fabry Disease 58 Sancuso 58 Torisel temsirolimus 58 Somatuline R Depot 58 Phase IIIb clinical 58 gluteal injection 58 sorafenib tablets 58 Arzerra TM 58 Market Authorization Application 58 Doribax 58 PROVENGE ® 58 ZEGERID Capsules 58 Pegloticase 58 ATryn ® GTC recombinant 58 Uracyst 58 Clofarabine 58 DepoDur 58 abatacept Orencia 58 CLIA waiver 58 QNEXA ® 58 ColonSentry test 58 Rapydan 58 BEMA Fentanyl 58 adult chronic ITP 58 QVAR ® 58 topical ophthalmic 58 Fablyn 58 brivaracetam 58 Metricath Gemini 58 oral cladribine 58 TYZEKA 58 Triage Stroke Panel 58 Cinryze ™ 58 Ramelteon 58 Erbitux cetuximab 58 Diamyd ® 58 Zavesca R 58 MyVax R 58 REPLAGAL 58 FOSAMAX PLUS D 58 PecFent 58 Levetiracetam 58 TAXUS Element Stent System 58 TRISENOX 58 Diamyd r 58 Mirapexin 58 Calcium Acetate 58 Kamada AAT 58 rasagiline tablets 58 Preos 58 clofarabine 58 Nexavar ® 57 ADVEXIN 57 MHLW 57 Rescula 57 Riluzole 57 Bronchitol 57 Increlex TM 57 Zensana 57 Tygacil 57 StemEx R 57 BENLYSTA 57 Hedgehog antagonist 57 Oncoscience 57 HepaSphere 57 Amrubicin 57 ISTODAX 57 FUSILEV ® 57 Genasense ® 57 HepaGam B TM 57 AFSSAPS 57 X Excite 57 Exalgo 57 TORISEL 57 COLAZAL R 57 Cerepro 57 PNT# 57 CAPHOSOL 57 FDA Complete Response 57 Urocidin TM 57 azficel T 57 Helsinn 57 hGH CTP 57 Campath ® 57 aleglitazar 57 Sensipar 57 Rapaflo 57 sumatriptan DosePro 57 IL# PE#QQR 57 Keppra XR 57 approvability 57 mifamurtide 57 Orphan Drug designations 57 MoxDuo IR 57 Clolar ® 57 Aphthasol R 57 Pfizer Sutent 57 PIX# trial 57 novel oral anticoagulant 57 Zidovudine Tablets 57 ORENCIA R 57 WHO prequalification 57 Oncoscience AG 57 FACTIVE tablets 57 Modrenal R 57 sNDA filing 57 Complete Response letter 57 EMBEDA ™ 57 Fodosine 57 KIACTA ™ 57 Ixiaro 57 Sutent sunitinib 57 OvaDx 57 acyclovir Lauriad ® 57 corticotropin injection 57 sitaxsentan sodium 57 Exelon rivastigmine 57 LibiGel ® 57 Pemetrexed 57 GALNS 57 Expanded Indication 57 EpiCeram 57 Subpart E 57 Ambrisentan 57 Urocidin 57 VIMOVO 57 Manja Bouman CEO 57 reslizumab 57 lorcaserin NDA 57 InvaGen 57 RoACTEMRA 57 Glybera 57 UVIDEM 57 INVEGA ® 57 Keryx Biopharma 57 Provenge prostate cancer 57 PROVIGIL 57 SPRIX ® 57 prGCD 57 Debiopharm SA 57 Elonva 57 guanfacine extended release 57 Aztreonam 57 ITAX 57 Gleevec Glivec 57 Filgrastim 57 Synvisc One 57 myelodysplastic myeloproliferative diseases 57 ARIXTRA 57 ANDA submission 57 Cethrin 57 HCl capsules 57 RhuDex ® 57 Roflumilast 57 Biologics License Application BLA 57 Keppra ® XR 57 Rapinyl 57 indacaterol 57 Alogliptin 57 Ophthalmic Drugs Advisory 57 Victrelis 57 CytoFab 57 indiplon capsules 57 Zelnorm Zelmac 57 sevelamer carbonate 57 FDA Accepts 57 Cayston 57 UCB Cimzia 57 forodesine 57 MOVIPREP R 57 Inavir 57 Exelbine 57 Qutenza TM 57 Clavis Pharma 57 Pivotal Phase III 57 Aplenzin 57 pain palliation 57 Perforomist ™ Inhalation Solution 57 Humenza 57 Decentralized Procedure DCP 57 GRALISE 57 Complete Response 57 Visian Toric ICL 57 eprodisate KIACTA TM 57 Promacta 57 Amgen Vectibix 57 GlycoPEG GCSF 57 Gabapentin GR 57 Vimpat 57 donepezil rivastigmine 57 acyclovir Lauriad R 57 WILEX AG 57 silodosin 57 anticancer compound 57 NUVIGIL 57 Pafuramidine 57 Astepro 57 Vantas 57 Lupin Pharmaceuticals Inc. 57 Retisert 57 Product Monograph 57 5 lipoxygenase inhibitor 57 LEVADEX ™ 57 Telavancin 57 Bazedoxifene 57 pradefovir 57 Sanofi Acomplia 57 Gonal f 57 Luveris 57 Arzerra 57 Periostat 57 eprotirome 57 Tavocept 57 Lamictal ODT 57 Mr. Yves Rosconi 57 Personalized Immunotherapy 57 ZEFTERA TM Zevtera TM 57 vismodegib 57 Onconase 57 Bendamustine 57 HepaGam B 57 Toctino 57 Fanapt TM 57 Phase IIa trial 57 QRxPharma 57 XAGRID 57 Pertuzumab 57 Atelvia 57 Simulect 57 Veregen R 57 NeoVisc 57 Amyvid 57 Synerx Pharma 57 Oracea TM 57 diabetic neuropathic pain 57 Roche Xeloda 57 ONTAK 57 PHX# 57 Impax ANDA 57 OMNARIS 57 POSIDUR TM 57 Firdapse 57 Azedra 57 Pfizer maraviroc 57 refractory chronic lymphocytic 57 sapropterin dihydrochloride 57 Androxal ® 57 Striant 57 DepoBupivacaine TM 57 BYDUREON 57 Cetrorelix 57 tolperisone 57 Gestiva TM 57 blood thinner prasugrel 57 Approvable letter 57 Accelerated Approval 57 PDUFA Prescription Drug 57 Patanase 57 Jevtana 57 Yondelis 57 Tesamorelin 57 Neurodex 57 Eucreas 57 Lumacan 57 IMiDs ® compound 57 Expedited Review 57 AVAX 57 Keppra ® 57 Dupuytren Contracture 57 Multaq R 57 Phase III Clinical Trial 56 Æterna Zentaris 56 EGRIFTA 56 PrevOnco 56 CERVARIX 56 VitiGam 56 Genzyme Myozyme 56 Prestara 56 APF# 56 Bicifadine 56 Virulizin R 56 ACIP recommendations 56 Zegerid OTC 56 TYGACIL 56 Ferinject 56 ENTEREG ® 56 Afluria 56 Panzem 56 heterozygous FH 56 Cimzia ® 56 QNEXA 56 Clolar 56 RAPAFLO 56 CEQ# 56 Combunox 56 etanercept Enbrel 56 diclofenac potassium 56 Erwinase 56 EXALGO 56 ALGRX 56 Polyphenon ® E 56 AERIUS 56 biologic therapy 56 CERVARIX R 56 Besivance 56 aclidinium 56 SILENOR TM 56 NanoCrystal technology 56 Aclasta 56 PGL# 56 Biologic License Application 56 Insegia 56 Afatinib 56 BROMDAY 56 EVICEL 56 PDUFA date 56 VISICOL R 56 Celgene Revlimid 56 NexACT ® 56 Itopride 56 Eloxatin ® 56 MabCampath 56 DYNEPO 56 Alinia 56 Cimzia TM 56 Daliresp 56 ZEFTERA ™ 56 IND Investigational New 56 Extina 56 SPARLON 56 rhThrombin 56 Azzalure R 56 Rebif ® 56 Mipomersen 56 thetreatment 56 NerPharMa 56 terlipressin 56 Satraplatin 56 Q#IR 56 ADDERALL XR R 56 Spiegelmer ® 56 Arixtra 56 EGRIFTA TM 56 Monovalent Vaccine 56 Exelbine NDA 56 LIALDA 56 Frova R 56 XGEVA 56 Simponi golimumab 56 JOULFERON 56 Sutent sunitinib malate 56 Golimumab 56 ® darbepoetin alfa 56 AstraZeneca Symbicort 56 Femara letrozole 56 RIGScan CR 56 EnzymeRx 56 XIAFLEX TM 56 Oracea 56 injectable diclofenac 56 STELARA TM 56 alogliptin 56 eltrombopag 56 THALOMID 56 Kit CD# positive 56 GRAS notification 56 pafuramidine 56 Visicol 56 Vernalis plc 56 DepoDur TM 56 Loramyc TM 56 solifenacin succinate 56 Glatiramer Acetate 56 casopitant 56 SNT-MC#/idebenone 56 Cenestin 56 FDA Antiviral Drugs 56 Priority Review 56 Diabetic Macular Edema 56 Scientific Advice 56 oral taxane 56 Anthim 56 ISO Vorin TM 56 PTK ZK 56 oral anticoagulant 56 IONSYS TM 56 taliglucerase alfa 56 TachoSil 56 PRISTIQ 56 Laquinimod 56 Velaglucerase Alfa 56 Oglemilast 56 GLASSIA 56 Arixtra ® 56 Adventrx 56 AZX# 56 Combidex 56 PEG INTRON 56 Topiramate Tablets 56 OZURDEX ® 56 Requip XL 56 supplemental Biologics License Application 56 AEterna 56 Anastrozole 56 Ticagrelor 56 Virulizin ® 56 topical NSAID 56 Glargine 56 Zenapax 56 nalbuphine ER 56 Shire BioChem Inc. 56 Thelin tm 56 Gynazole 1 56 SEASONIQUE 56 application sNDA 56 Coreg CR 56 DC Bead 56 TORISEL TM 56 HuMax EGFr 56 ONCASPAR 56 rThrombin 56 single injection viscosupplement 56 BioSTAR R 56 FDA Accelerated Approval 56 Zuplenz 56 Accelerated Assessment 56 sorafenib Nexavar 56 Prodarsan R 56 Vivaglobin 56 cervical cancer vaccine Cervarix 56 Mylotarg 56 SOLODYN 56 AMITIZA ® 56 Medicines Consortium 56 Kaletra tablet 56 Menaflex implant 56 UPLYSO 56 IV acetaminophen 56 USFDA approval 56 OHR/AVR# 56 orBec 56 Stelara 56 BeneFIX 56 Azilect ® 56 prucalopride 56 MabThera rituximab 56 Septin 9 56 Zentase 56 Vimovo 56 LibiGel NDA 56 SANVAR 56 refractory APL 56 CNTO 56 ZALBIN 56 midstage studies 56 ATryn R 56 Aptivus 56 FDA Oncologic Drugs 56 REVLIMID R 56 XYZAL ® 56 SANCTURA XR 56 sumatriptan injection 56 Boceprevir 56 oral dual endothelin 56 Eribulin 56 Centralised Procedure 56 Azathioprine 56 DigiFab TM 56 k Premarket Notification 56 Phase IIb trials 56 Octreolin 56 Periowave TM 56 Pulminiq 56 SEASONALE 56 Vpriv 56 vaccine Synflorix 56 OLEPTRO TM 56 oral rivaroxaban 56 Thelin TM 56 methylnaltrexone bromide 56 DDP# 56 Neupro ®

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