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  • Comité Technique des Spécialités Pharmaceutiques du 7 Mars 2018

    Comité Technique des Spécialités Pharmaceutiques du 7 Mars 2018

Dossiers d'AMM à étudier par le Comité Technique des Spécialités Pharmaceutiques du 07/03/2018.

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

Spécialités Pharmaceutiques importées :

* Produits déjà évalués lors des derniers Comités Techniques

N° Médicament DCI Dosage Forme Pharmaceutique Présentation TITULAIRE
1 CORTIMENT MMX BUDESONIDE 9mg COMPRIME LP B/20 FERRING ARZNEIMITTEL GmbH
2 QPIME CEFEPIME 1gr SOL INJ B/1FL JULPHAR
3 ITAMI DICLOFENAC 140mg EMPLATRE B/5 FIDIA PHARMACEUTICAL
4 SIGNIFOR PASIREOTIDE 0,3mg/ml SOL INJ B/30 NOVARTIS
5 SIGNIFOR PASIREOTIDE 0,6mg/ml SOL INJ B/30 NOVARTIS
6 SIGNIFOR PASIREOTIDE 0,9mg/ml SOL INJ B/30 NOVARTIS
7 OZURDEX DEXAMETHASONE 700 µg IMPLANT B/1 ALLERGAN PHARMACEUTICALS
8 HEBERPROT P FACTEUR DE CROISSANCE EPIDERMIQUE HUMAIN RECOMBINANT 75 µg PDRE PREP INJ B/6 CIGB
9 MYDRIASERT TROPICAMIDE+PHENYLEPHRINE 0,28mg/  5,4mg IMPLANT B/20 THEA
10 TYSABRI NATILUZUMAB 300mg SOLUTION INJECTABLE B/1FL/15ml BIOGEN IDEC LTD
11 TECFIDERA DIMETHYLFUMARATE 120mg GELULE B/14 BIOGEN IDEC LTD
12 TECFIDERA DIMETHYLFUMARATE 240mg GELULE B/56 BIOGEN IDEC LTD
13 GARDASIL QUADRIVALENT HUMAN PAPILLOMAVIRUS SUSPENSION INJECTABLE B/1FL/0,5ml MERCK &CO 
14 HYALOSILVER HYALURONATE DE SODIUM 0,002 PDRE USAGE EXTERNE FL/50ml FIDIA PHARMACEUTICAL
15 PICOPREP PICOSULFATE DE SODIUM+OXYDE DE MG SACHETS B/2 FERRING SAS
16 DIVIDO DICLOFENAC SODIQUE 75 mg GELULE LP B/20 TABUK
17 TOPOTECAN KABI TOPOTECAN 1mg/ml PDRE PREP INJ B/ 1 Flacon FRESENIUS KABI ONCOLOGY PLC
18 ZALTRAP AFLIBERCEPT 25mg/ml  SOLUTION INJECTABLE Fl/4ml  SANOFI AVENTIS
19 ZALTRAP AFLIBERCEPT 25mg/ml  SOLUTION INJECTABLE Fl/4ml  SANOFI AVENTIS
20 LOTEVAN AMLODIPINE+VALSARTAN 5/160mg COMPRIME B/30 TABUK Pharmaceutical
21 LOTEVAN AMLODIPINE+VALSARTAN 10/160mg COMPRIME B/30 TABUK Pharmaceutical
22 LATAZ  0,005%  LATANOPROST 50 mcg/ml Collyre    FL/2.5 ML RAFARM SA
23 LATAZ  0CO  LATANOPROST+TIMOLOL Collyre    FL/2.5 ML RAFARM SA
24 OPTODROP-CO DORZOLAMIDE +TIMOLOL Collyre FL/5 ML RAFARM SA
25 AUBAGIO TERIFLUNOMIDE COMPRIME PELLICULE B/28 SANOFI AVENTIS 
26 FRAGOR DELAPRIDE+MANIDIPINE 30mg+10mg COMPRIME B/28 CHIESI Italie
27 OFEV NINTEDANIB 100mg CAPSULE MOLLE B/60 BOEHRINGER
28 OFEV NINTEDANIB 150mg CAPSULE MOLLE B/60 BOEHRINGER
29 DIANEAL PD4 GLUCOSE+ELECTROLYTES 3,86 SOL DIALYSE PERI POCHE 2L BAXTER UK
30 DIANEAL PD4 GLUCOSE+ELECTROLYTES 2,27 SOL DIALYSE PERI POCHE 2L BAXTER UK
31 DIANEAL PD4 GLUCOSE+ELECTROLYTES 1,36 SOL DIALYSE PERI POCHE 5L BAXTER UK
32 DIANEAL PD4 GLUCOSE+ELECTROLYTES 1,36 SOL DIALYSE PERI POCHE 2L BAXTER UK
33 DIANEAL PD4 GLUCOSE+ELECTROLYTES 2,27 SOL DIALYSE PERI POCHE 5L BAXTER UK
34 BICALUTAMIDE ACCORD BICALUTAMIDE 50MG COMPRIME PELLICULE B/28 ACCORD HAELTHCARE
35 OPDIVO NIVOLUMAB 40 mg/4 ml SOL INJECTABLE B/1FL/4ml BMS
36 OPDIVO NIVOLUMAB 100 mg/10 ml SOL INJECTABLE B/1FL/10ml BMS
37 EFIENT PRASUGREL 5MG COMPRIME B/28 DAIICHI SANKYO EUROPE 
38 EFIENT PRASUGREL 10MG COMPRIME B/28 DAIICHI SANKYO EUROPE 
39 VIGAMOX MOXIFLOXACINE 5MG/ML COLLYRE FL/5ML ALCON
40 ORFADIN NITISINONE 20MG GELLULE FL/60 SOBI 
41 ORFADIN NITISINONE 4MG/ML SUSP ORALE FL/90ML SOBI 
42 KIVEXA ABACAVIR/LAMIVUDINE 600/300MG COMPRIME PELLICULE B/30 VIIV HAETHCARE

* Produits à évaluer pour la première fois au Comité Technique

N° Médicament DCI Dosage Forme Pharmaceutique Présentation TITULAIRE
1 ADENURIC FEBUXOSTAT 80MG COMPRIME   B/28 ALGORITHM
2 ADENURIC FEBUXOSTAT 120MG COMPRIME   B/28 ALGORITHM
3 URAPIDIL STRAGEN IV URAPIDIL 25MG/5ML SOL INJ B/5AP/5ML STRAGEN
4 URAPIDIL STRAGEN IV URAPIDIL 50MG/5ML SOL INJ B/5AP/5ML STRAGEN
5 VITALIPIDE ENFANTS VITAMINES EMULSION INJ B/10AP/10ML FRESENIUS KABI
6 VITALIPIDE ADULTES VITAMINES EMULSION INJ B/10AP/10ML FRESENIUS KABI
7 IMETH METHOTREXATE 15MG SOL INJ B/4 SERINGUES/0,6ML NORDIC GROUP BV
8 IMETH METHOTREXATE 25MG SOL INJ B/4 SERINGUES/1ML NORDIC GROUP BV
9 IMETH METHOTREXATE 20MG SOL INJ B/4 SERINGUES/0,8ML NORDIC GROUP BV
10 FLUTIFORM NAPPPPHARMACEUTICAL UK 250MG/105MG SUSP P INHALATION B/1FL/120DOSES NAPP PHARMACEUTICALS LTD UK
11 DOLIPRANE PARACETAMOL 1000MG GELULES B/8 SANOFI AVENTIS France
12 CEFTAZIDIM SANDOZ CEFTAZIDIME 1GR PDRE PREP INJ B/10FL/20ML SANDOZ GMBH Autriche
13 MYDOCALM HYDROCHLORURE DE TOLPORISONE 150MG COMPRIME  B/30 LABETEC PHARMA
14 LEVOTIRAN LEVOTHYROXINE SODIQUE 25µG COMPRIME B/100 ABDI IBRAHIM
15 LEVOTIRAN LEVOTHYROXINE SODIQUE 50µG COMPRIME B/100 ABDI IBRAHIM
16 LEVOTIRAN LEVOTHYROXINE SODIQUE 100µG COMPRIME B/100 ABDI IBRAHIM
17 XERACTAN ISOTRETINOINE 10MG CAPSULE MOLLE B/30 JAZEERA PHARMACEUTICAL INDUSTRIES
18 XERACTAN ISOTRETINOINE 20MG CAPSULE MOLLE B/30 JAZEERA PHARMACEUTICAL INDUSTRIES
19 PHOCYTAN GLUCOSE-1-DISODIUM TETRAHYDRATE 0,66mmol/ml SOL INJ PERFUSION B/50/10ML AGUETTANT
20 PIASCLEDINE 300  INSAPONIFIABLE HUILE D AVOCAT ET DE SOJA 300MG GELULES B/30 EXPANSCIENCE
21 NERVAX  PREGABALINE 75MG GELULES B/20 TABUK PHARMACEUTICAL
22 NERVAX  PREGABALINE 150MG GELULES B/60 TABUK PHARMACEUTICAL
23 MIRVASO BRIMONIDINE TARTRATE 3MG/GR GEL T/30GR GALDERMA
24 DESOGESTREL/ ETHINYLESTRADIOL DESOGESTREL/ ETHINYLESTRADIOL 150µG/20YG COMPRIME B/21 MYLAN SAS
25 DESOGESTREL/ ETHINYLESTRADIOL DESOGESTREL/ ETHINYLESTRADIOL 150µG/20YG COMPRIME B/3/21 MYLAN SAS
26 DESOGESTREL/ ETHINYLESTRADIOL DESOGESTREL/ ETHINYLESTRADIOL 150µG/30YG COMPRIME B/21 MYLAN SAS
27 DESOGESTREL/ ETHINYLESTRADIOL DESOGESTREL/ ETHINYLESTRADIOL 150µG/30YG COMPRIME B/3/21 MYLAN SAS
28 PERJETA PERTUZUMAB 420MG/14ML SOL INJ PERFUSION B/1FL ROCHE PHARMA
29 LAMICTAL LAMOTRIGINE 2MG COMPRIME A CROQUER B/1FL/30 GSK France
30 ZYTIGA ABIRATERONE 250MG COMPRIME B/120 JANSSEN-CILAG
31 ERBITUX CETUXIMAB 500MG/ML SLO PERF FL/100 ML MERCK 
32 ERBITUX CETUXIMAB 5MG/ML SOL INJ PERFUSION B/1FL/25ML MERCK 
33 SOMATULINE LP LANREOTIDE 60 MG SOL INJ B/1 SERINGUE IPSEN  PHARMA
34 SOMATULINE LP LANREOTIDE 90 MG SOL INJ B/1 SERINGUE IPSEN  PHARMA
35 SOMATULINE LP LANREOTIDE 120 MG SOL INJ B/1 SERINGUE IPSEN  PHARMA
36 VECTIBIX PANITUMUMAB 100MG/5ML SOL PERF B/1FL/20ML AMGEN EUROPE BV
37 VECTIBIX PANITUMUMAB 400MG/20ML SOL PERF B/1FL/20ML AMGEN EUROPE BV
38 JEVTANA CABAZITAXEL 60MG SOL INJ PERFUSION B/1FL+1FL SLVT SANOFI AVENTIS France
39 CAMPTO IRINOTECAN 20MG/ML SOL INJ PERFUSION B/1FL/2ML PFIZER HOLDING
40 CAMPTO IRINOTECAN 20MG/ML SOL INJ PERFUSION B/1FL/5ML PFIZER HOLDING
41 CAMPTO IRINOTECAN 20MG/ML SOL INJ PERFUSION B/1FL/15ML PFIZER HOLDING
42 VARGATEF NINTEDANIB 100MG CAPSULES MOLLES B/120 BOEHRINGER
43 SUTENT SUNITINIB 12,5MG GELULES B/28 PZIFER LTD
44 SUTENT SUNITINIB 25MG GELULES B/28 PZIFER LTD
45 SUTENT SUNITINIB 50MG GELULES B/28 PZIFER LTD
46 DECAPEPTYL LP TRIPTORELINE 3MG PDRE PREP INJ B/1FL+SLVT IPSEN PHRAMA
47 AVASTIN BEVACIZUMAB 100MG SOL INJ B/1FL/16ML ROCHE PHARMA
48 AVASTIN BEVACIZUMAB 400MG SOL INJ B/1FL/16ML ROCHE PHARMA
49 AFINITOR EVEROLIMUS 5MG COMPRIME B/30 NOVARTIS
50 AFINITOR EVEROLIMUS 10MG COMPRIME B/30 NOVARTIS
51 KEVESEY LEVITIRACETAM 5MG/ML SOL,INJ B/10POCHES STRAGEN
52 KEVESEY LEVITIRACETAM 10MG/ML SOL,INJ B/10POCHES STRAGEN
53 KEVESEY LEVITIRACETAM 15MG/ML SOL,INJ B/10POCHES STRAGEN
54 XTANDI ENZALUTAMIDE 40MG CAPSULES MOLLES B/112 ASTELLAS PHARMA
55 MONTELUKAST MYLAN MONTELUKAST 5MG COMPRIME A CROQUER B/28 MYLAN SAS
56 ATROPINE SULFATE AGUETTANT ATROPINE SULFATE 0,5MG SOL INJ B/10/5ML AGUETTANT
57 ATACAND CANDESERTAN CILEXETIL 4MG COMPRIME SECABLE B/30 ASTRA ZENECA
58 ATACAND CANDESERTAN CILEXETIL 8MG COMPRIME SECABLE B/30 ASTRA ZENECA
59 ATACAND CANDESERTAN CILEXETIL 16MG COMPRIME SECABLE B/30 ASTRA ZENECA
60 DOBUTAMINE MYLAN DOBUTAMINE 250MG/20ML SOL INJ B/10/20ML MYLAN SAS
61 BRONCHODUAL FENOTEROL+IPRATROPIUM 50µG/20µG SOL INHAL FL/200DOSES BOEHRINGER INGELHEIM
62 STELARA USTEKINUMAB 45MG/0,5ML SOL INJ B/1FL JANSSEN-CILAG
63 STELARA USTEKINUMAB 45MG/0,5ML SOL INJ B/1 SERINGUE PRE-REMPLIE JANSSEN-CILAG
64 STELARA USTEKINUMAB 90MG/ML SOL INJ B/1 SERINGUE PRE-REMPLIE JANSSEN-CILAG
65 HYALOSILVER HYALURONATE DE SODIUM 0,002 PDRE USAGE EXTERNE FL/125ML FIDIA PHARMACEUTICAL
66 DROPERIDOL AGUETTANT DROPERIDOL 1,25MG/ML SOL INJ B/10AMPLES/1ML AGUETTANT
67 ALDURAZYME LARONIDASE 100U/ML CONCENTRE STERILE B/1FL GENZYME
68 EPIDUO  ADAPALENE+PEROXYDE DE BENZOYLE 0,1%+2,5% GEL FL/30GR GALDERMA
69 MEROPENEM KABI MEROPENEME TRIHYDRATE 1GR SOL,INJ B/10FL/20ML FREISINIUS KABI
70 ZYTIGA ACETATE ABIRATERONE 500MG COMPRIME PELLICULE B/56 JANSSEN CILAG

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