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  • Comité Technique des Spécialités Pharmaceutiques du 29 Août 2018

    Comité Technique des Spécialités Pharmaceutiques du 29 Août 2018

Dossiers d'AMM à étudier par le Comité Technique des Spécialités Pharmaceutiques du 29/08/2018.

Pour ce comité technique, l’ordre de passage des dossiers sera comme suit .

Spécialités Pharmaceutiques importées :

* Produits à évaluer pour la première fois au Comité Technique

N° Médicament DCI Dosage Forme Pharmaceutique Présentation TITULAIRE
1 LIPIODOL ULTRA FLUIDE HUILE D OEILETTE ESTERS ETHYL 480 MG/ML SOL INJ B/1AMP/10ML GUERBET
2 MORPHINE CHLORHYDRATE AGUETTANT MORPHINE 0,1MG/ML SOL INJ B/10AMP/5ML AGUETTANT
3 DUROGESIC 12 FENTANYL 12µG/H DISPOSITIF TRANSDERMIQUE B/5 JANSSEN CILAG
4 DUROGESIC 25 FENTANYL 25µG/H DISPOSITIF TRANSDERMIQUE B/5 JANSSEN CILAG
5 DUROGESIC 50 FENTANYL 50µG/H DISPOSITIF TRANSDERMIQUE B/5 JANSSEN CILAG
6 DUROGESIC 75 FENTANYL 75µG/H DISPOSITIF TRANSDERMIQUE B/5 JANSSEN CILAG
7 DUROGESIC 100 FENTANYL 100µG/H DISPOSITIF TRANSDERMIQUE B/5 JANSSEN CILAG
8 SIMPONI GOLIMUMAB 50 MG SOL INJ B/1 STYLO PR2E-REMPLI JANSSEN CILAG
9 APROKAM  CEFUROXIME SODIQUE 50MG SOL INJ B/10FL THEA
10 STABLON TIANEPTINE 12,5 MG COMPENROBE B/28 SERVIER
11 FINASTERIDE ACCORD FINASTERIDE 5MG/ML COMPRIME PELLICULE B/28 ACCORD UK
12 TELMISERTAN KERN PHARMA TELMISERTAN 40MG COMPRIME B/28 KERN PHARMA
13 TELMISERTAN KERN PHARMA TELMISERTAN 80MG COMPRIME B/28 KERN PHARMA
14 ROPIVACAINE HYDROCHLORIDE  ROPIVACAINE 10MG/ML SOL INJ B/10FL/20ML HOSPIRA CANADA
15 PRADAXA DABIGATRON 150MG GELULE B/60 BOEHRINGER IN
16 PRADAXA DABIGATRON 110MG GELULE B/30 BOEHRINGER IN
17 PRADAXA DABIGATRON 110MG GELULE B/60 BOEHRINGER IN
18 PRAXBIND IDARUCIZUMAB 2,5GR/50ML SOL INJ PERF B/2FL BOEHRINGER IN
19 YDRALBUM ALBUMIN HUMAINE 10GR SOL INJ PERF B/1FL/50ML LFB France
20 YDRALBUM ALBUMIN HUMAINE 20GR SOL INJ PERF B/1FL/100ML LFB France
21 TRITAZIDE RAMIPRIL/HYDROCHLOROTHIAZIDE 5/25GR COMP SEC B/28 SANOFI Belgique
22 ACTILYSE ALTEPLASE 10MG PDRE PREP INJ B/1FL+SLVT BOEHRINGER IN
23 ACTILYSE ALTEPLASE 20MG PDRE PREP INJ B/1FL+SLVT BOEHRINGER IN
24 ACTILYSE ALTEPLASE 50MG PDRE PREP INJ B/1FL+SLVT BOEHRINGER IN
25 CARVIDOL CARVEDILOL 12,5MG COMP SEC B/30 PHARMA INTERNATIONAL JORDAN
26 RELVAR ELIPTA FLUTICASONE+VILANTEROL 184/22 PDRE INHAL BUC B/1 GSK UK
27 RELVAR ELIPTA FLUTICASONE+VILANTEROL 92/22 PDRE INHAL BUC B/1 GSK UK
28 ADRENALINE AGUETTANT SANS SULFITE ADRENALINE 5MG SOL INJ B/10 AGUETTANT France
29 LEMTRADA ALEMTUZUMAB 12MG SOL PERF B/1FL GENZYME UK
30 TARGINACT OXYCODONE+MALAXONE 10MG/5MG COMP LP B/56 NAPP PHARMACEUTICAL UK
31 TARGINACT OXYCODONE+MALAXONE 20MG/10MG COMP LP B/56 NAPP PHARMACEUTICAL UK
32 TARGINACT OXYCODONE+MALAXONE 40MG/20MG COMP LP B/56 NAPP PHARMACEUTICAL UK
33 NOMEGESTROL STRAGEN  NOMEGESTROL 5MG COMPRIME B/10 STRAGEN NORDIC A/S
34 OPTIFUCIN  ACIDE FUSIDIQUE 1% GEL OPHTALMIQUE T/5 gr API-Jordanie
35 DICYNONE ETAMSYLATE 500MG COMPRIME B/20 VIFOR France
36 FABRAZYME Agalsidase Béta 35 mg    PP Sol Inj P PERF B/1 FL API-Jordanie
38 AZOPT BRINZOLAMIDE 1% COLLYRE FL/5ML NOVARTIS EUROPHARM
39 OPATANOL OLOPATADINE   COLLYRE FL/5ML NOVARTIS EUROPHARM
40 MABTHERA RITUXIMAB 1400MG/11,7ML SOL INJ B/1FL ROCHE 
41 DUOTRAV TRAVOPROST+TIMOLOL   COLLYRE FL/2,5ML NOVARTIS EUROPHARM
42 TRAVATAN TRAVOPROST   COLLYRE FL/2,5ML NOVARTIS EUROPHARM
43 CLARISCAN ACIDE GADOTERIQUE 0,05 MMOL/ML SOL INJ B/10FL/10ML GE HEALTHCARE
44 CLARISCAN ACIDE GADOTERIQUE 0,05 MMOL/ML SOL INJ B/10FL/15ML GE HEALTHCARE
45 CLARISCAN ACIDE GADOTERIQUE 0,05 MMOL/ML SOL INJ B/10FL/20ML GE HEALTHCARE
46 CEREZYME IMIGLUCERASE 400UI PDRE SOL PERF B/1FL GENZYME 
47 ACIDE ZOLEDRONIQUE MYLAN ACIDE ZOLEDRONIQUE 4MG/5ML SOL PERF B/1FL MYLAN
48 DUOFILM A,LACTIQUE+A,SALICYLIQUE   SOL,AP,LOCALE FL/15ML GSK France
49 BETMIGA MIRABEGOM 50MG COMP LP B/30 ASTELLAS PAYS BAS
50 BRIMO BRIMONIDINE TARTRATE 0,20% COLLYRE FL/5ML JAMJOOM PHARMA
51 LOTEMAX LOTEPREDNOL ETABONATE 0,10% GEL OPHTALMIQUE FL/10ML BAUSH&LOMB
52 RILAMIG FROVATRIPTAN 2,5mg COMPRIME PELLICULE B/2 MENARINI 
53 RILAMIG FROVATRIPTAN 2,5mg COMPRIME PELLICULE B/6 MENARINI 
54 COSIMPREL FUMARATE DE BISOPROLOL 10MG/10MG COMPRIME PELLICULE B/30 SERVIER 
55 COSIMPREL FUMARATE DE BISOPROLOL 10MG/5MG COMPRIME PELLICULE B/30 SERVIER 
56 COSIMPREL FUMARATE DE BISOPROLOL 5MG/5MG COMPRIME PELLICULE B/30 SERVIER 
57 COSIMPREL FUMARATE DE BISOPROLOL 5MG/10MG COMPRIME PELLICULE B/30 SERVIER 

* Produits déjà évalués lors des derniers Comités Techniques

N° Médicament DCI Dosage Forme Pharmaceutique Présentation TITULAIRE
1 ZINFORO CEFTAROLINE FOSAMIL 600MG PDRE SOL PERF B/10FL ASTRA ZENECA
2 PRILIGY DAPOXETINE 30MG CP PELL B/3 MINARINI
3 PRILIGY DAPOXETINE 60MG CP PELL B/3 MINARINI
4 JAKAVI RUXOLITINIB 5MG COMPRIME B/56 NOVARTIS PHARMA SUISSE
5 JAKAVI RUXOLITINIB 15MG COMPRIME B/56 NOVARTIS PHARMA SUISSE
6 JAKAVI RUXOLITINIB 20MG COMPRIME B/56 NOVARTIS PHARMA SUISSE
7 IMBRUVICA IBRUTINIB 140MG GELULE B/90 JANSSEN CILAG
8 APOKINON APOMORPHINE 30MG SOLUTION INJECTABLE B/1 STYLO/3ML AGUETTANT
9 APOKINON APOMORPHINE 30MG SOLUTION INJECTABLE B/5 STYLO/3ML AGUETTANT
10 PERJETA PERTUZUMAB 420MG/14ML SOL INJ PERFUSION B/1FL ROCHE PHARMA
11 TOUJEO SOLOSTAR INSULINE GLARGINE 300UI/ML SOL INJ PERFUSION B/3 STYLOS SANOFI AVENTIS Allemagne
12 VELCADE BORTEZOMIB 3,5MG PDRE PREP INJ B/1FL JANSSEN CILAG 
13 OFEV NINTEDANIB 100MG CAPSULE MOLLE B/60 BOEHRINGER INGELHEIM
14 OFEV NINTEDANIB 150MG CAPSULE MOLLE B/60 BOEHRINGER INGELHEIM
15 DESOGESTREL/ ETHINYLESTRADIOL DESOGESTREL/ ETHINYLESTRADIOL 150µG/20YG COMPRIME B/21 MYLAN SAS
16 DESOGESTREL/ ETHINYLESTRADIOL DESOGESTREL/ ETHINYLESTRADIOL 150µG/20YG COMPRIME B/3/21 MYLAN SAS
17 DESOGESTREL/ ETHINYLESTRADIOL DESOGESTREL/ ETHINYLESTRADIOL 150µG/30YG COMPRIME B/21 MYLAN SAS
18 DESOGESTREL/ ETHINYLESTRADIOL DESOGESTREL/ ETHINYLESTRADIOL 150µG/30YG COMPRIME B/3/21 MYLAN SAS
19 ASMANEX TWISTHALER FUROATE DE MOMETASONE 20µG/DOSE PDRE INHAL B/60 MSD France
20 ASMANEX TWISTHALER FUROATE DE MOMETASONE 200µG/DOSE PDRE INHAL B/30 MSD France
21 XELJANZ TOFACITINIB 5MG COMPRIME B/60 PFIZER PRISM
22 XALKORI CRIZOTINIB 200MG GELULE B/60 PFIZER PRISM
23 XALKORI CRIZOTINIB 250MG GELULE B/60 PFIZER PRISM
24 TORISEL TEMSIROLIMUS           25 mg/ml (30mg)     SOL INJ PERFUSION B/ 1Fl + Diluant de 2.2 ml PFIZER Limited UK       
25 INLYTA AXITINIB  1MG COMPRIME B/28 PFIZER AG  
26 INLYTA AXITINIB  1MG COMPRIME B/56 PFIZER AG  
27 INLYTA AXITINIB  5MG COMPRIME B/28 PFIZER AG  
28 INLYTA AXITINIB  5MG COMPRIME B/56 PFIZER AG  
29 AFINITOR EVEROLIMUS 10MG COMPRIME B/30 NOVARTIS
30 SINOVIAL HYALURONATE DE SODIUM 16MG/2ML SOL INJ B/3 SERINGUES IBSA FARMACEUTICI
31 ORFADIN NITISINONE 20MG GELULES FL/60 SOBI
32 ORFADIN NITISINONE 4MG/ML SUSP BUVABLE B/1FL/100ML SOBI
33 JEVTANA CABAZITAXEL 60MG SOL INJ PERFUSION B/1FL+1FL SLVT SANOFI AVENTIS France
34 AUBAGIO TERIFLUNOMIDE 14 mg COMPRIME PELLICULE B/28 SANOFI AVENTIS 
35 STELARA USTEKINUMAB 45MG/0,5ML SOL INJ B/1FL JANSSEN-CILAG
36 STELARA USTEKINUMAB 45MG/0,5ML SOL INJ B/1 SERINGUE PRE-REMPLIE JANSSEN-CILAG
37 STELARA USTEKINUMAB 90MG/ML SOL INJ B/1 SERINGUE PRE-REMPLIE JANSSEN-CILAG
38 ALDURAZYME LARONIDASE    100U/ML          SOL INJ PERFUSION B/1FL/5ML GENZYME Europe B.V    
39 FLUTIFORM 125 FLUTICASONE PROPIONATE + FORMOTÉROL FUMARATE DIHYDRATÉ 125 µg/10µg   susp inhal B/1Fl pressurisé /120 doses  Napp Pharmaceuticals Limited    
40 FLUTIFORM 250 FLUTICASONE PROPIONATE + FORMOTÉROL FUMARATE DIHYDRATÉ 250 µg/10µg   susp inhal B/1Fl pressurisé /120 doses  Napp Pharmaceuticals Limited    
41 PHENYLEPHRINE AGUETTANT PHENYLEPHRINE 50µG/ML SOL INJ B/10 SERINGUE PRE-REMPLIE AGUETTANT
42 IMETH METHOTREXATE 15MG/0,6ML SOL INJ B/4SERINGUE PRE-REMPLIE NORDIC
43 IMETH METHOTREXATE 20MG/0,8ML SOL INJ B/4SERINGUE PRE-REMPLIE NORDIC
44 IMETH METHOTREXATE 25MG/ML SOL INJ B/4SERINGUE PRE-REMPLIE NORDIC
45 JENTADUETO LINAGLIPTINE+METFORMINE 2,5/850MG CP PELL B/56 BOEHRINGER INGELHEIM
46 JENTADUETO LINAGLIPTINE+METFORMINE 2,5/1000MG CP PELL B/56 BOEHRINGER INGELHEIM
47 VICTOZA LIRAGLUTIDE 6MG/ML SOL INJ B/2STYLOS/3ML NOVONORDISK
48 TRAJENTA LINAGLEPTINE 5MG CP PELL B/28 BOEHRINGER INGELHEIM
49 HEBERPROT-P  FACTEUR DE CROISSANCE EPIDERMIQUE RECOMBINANT 75mcg pdre prep inj B/6FL CIGB CUBA
50 MEROPENEM KABI MEROPENEM 1GR PDR SOL PERF B/10FL FRESENIUS France
51 ADENURIC 80 FEBUXOSTAT 80MG COMP PELL B/28 ALGORITHM
52 ADENURIC 120 FEBUXOSTAT 120MG COMP PELL B/28 ALGORITHM
53 DROPERIDOL AGUETTANT DROPERIDOL  1,25MG/ML AMPOULE B/10/1ML AGUETTANT
54 HYALOSILVER HYALURONATE DE SODIUM 0,20% PDRE APPL LOCALE FL/125ML FIDIA Italie
55 OXYNORM OXYCODONE HCL 5MG GELULE B/56 NAPP PHARMACEUTICAL
56 OXYNORM OXYCODONE HCL 10MG GELULE B/56 NAPP PHARMACEUTICAL
57 OXYNORM OXYCODONE HCL 20MG GELULE B/56 NAPP PHARMACEUTICAL
58 NEBILET NEBIVOLOL 5MG CP SECABLE B/30 MENARINI
59 URAPIDIL STRAGEN IV URAPIDIL 25MG/5ML SOL INJ B/5 STRAGEN NORDIC A/S
60 URAPIDIL STRAGEN IV URAPIDIL 50MG/10ML SOL INJ B/5 STRAGEN NORDIC A/S
61 ZYTIGA ACETATE D ABIRATERONE 500MG COMPRIME FL/56 JANSSEN
62 ZYTIGA ACETATE D ABIRATERONE 250MG COMPRIME FL/120 JANSSEN
63 ENANTYUM DEXKETOPROFENE 25 mg Granulés pour solution buvable B/20 sachets MENARINI S.A ESPAGNE
64 ENANTYUM DEXKETOPROFENE 25 mg Comprimé pelliculé B/20 MENARINI S.A ESPAGNE
65 ENANTYUM DEXKETOPROFENE 50 mg/2 ml Solution injectable B/6/2ml MENARINI S.A ESPAGNE




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