Dossiers d'AMM à étudier par le Comité Technique des Spécialités Pharmaceutiques du 01/07/2016.

DCI Médicament Dosage Forme Pharmaceutique Présentation Laboratoire Pharmaceutique
1 VORICONAZOLE VFEND 50 mg Comprimé pelliculé B/28 PFIZER Limited UK
2 VORICONAZOLE VFEND 200 mg Comprimé pelliculé B/14 PFIZER Limited UK
3 VORICONAZOLE VFEND 200 mg Pdre p.prep.injectable B/1FLACON PFIZER Limited UK
4 LEVOFLOXACINE TAVANIC 5 MG/ML Solution injectable FL/100 ML SANOFI-AVENTIS FRANCE
5 TIGECYCLINE TYGACIL 50  mg Pdre p.prep.injectable B/10 flacons PFIZER Limited UK
6 LINAGLIPTINE TRAJENTA 5 mg Comprimé pelliculé B/28 BOEHRINGER ING.INT.GmbH
7 LINAGLIPTINE + CHLORHYDRATE DE METFORMINE JENTADUETO 2.5 mg/ 1000 mg Comprimé pelliculé B/56 BOEHRINGER ING.INT.GmbH
8 LINAGLIPTINE + CHLORHYDRATE DE METFORMINE JENTADUETO 2.5 mg/ 850 mg Comprimé pelliculé B/56 BOEHRINGER ING.INT.GmbH
9 TELMISARTAN+AMLODIPINE TWYNSTA 40 mg/10 mg Comprimé B/28 BOEHRINGER ING.INT.GmbH
10 TELMISARTAN+AMLODIPINE TWYNSTA 80 mg/10 mg Comprimé B/28 BOEHRINGER ING.INT.GmbH
11 TELMISARTAN+AMLODIPINE TWYNSTA 40 mg/5 mg Comprimé B/28 BOEHRINGER ING.INT.GmbH
12 TELMISARTAN+AMLODIPINE TWYNSTA 80 mg/5 mg Comprimé B/28 BOEHRINGER ING.INT.GmbH
13 FENOTEROL+IPRATROPIUM BRONCHODUAL 50 µg/20 µg Suspension pour inhalation FL/200 DOSES BOEHRINGER INGELHEIM FRANCE
14 SAXAGLIPTIN+METFORMINE KOMBIGLYZE XR 5 mg/500 mg Comprimé B/30 ASTRA ZENCA AB SUEDE
15 SAXAGLIPTIN+METFORMINE KOMBIGLYZE XR 5 mg/1000 mg Comprimé B/30 ASTRA ZENCA AB SUEDE
16 saxagliptine ONGLYZA 5 mg Comprimé pelliculé FL/30 ASTRA ZENCA AB SUEDE
17 VILDAGLIPTINE+METFORMINE GALVUMET 50 mg/850 mg Comprimé pelliculé B/60 NOVARTIS PHARMA SCHWEIZ AG
18 SITAGLIPTINE+METFORMINE JANUMET 50 mg/850mg Comprimé pelliculé B/56 Merck Sharp & Dohme Ltd R.U
19 RANITIDINE AZANTAC 150 MG Comprimé effervescent B/2TUBES/15 GlaxoSmithKline France
20 DICLOFENAC FLECTOR TISSUGEL EP 1% Emplatre B/5 emplatres Laboratoires GENEVRIER S.A
21 DABIGATRAN PRADAXA 150 mg Gélule B/60 BOEHRINGER ING.INT.GmbH
22 DABIGATRAN PRADAXA 110 mg Gélule B/30 BOEHRINGER ING.INT.GmbH
23 DABIGATRAN PRADAXA 110 mg Gélule B/60 BOEHRINGER ING.INT.GmbH
24 RIVAROXABAN XARELTO 15 mg Comprimé pelliculé B/14 BAYER PHARMA AG
25 RIVAROXABAN XARELTO 15 mg Comprimé pelliculé B/42 BAYER PHARMA AG
26 RIVAROXABAN XARELTO 15 mg Comprimé pelliculé B/28 BAYER PHARMA AG
27 RIVAROXABAN XARELTO 20 mg Comprimé pelliculé B/14 BAYER PHARMA AG
28 RIVAROXABAN XARELTO 20 mg Comprimé pelliculé B/28 BAYER PHARMA AG
29 APIXABAN ELIQUIS 5 mg Comprimé pelliculé B/20 Bristol-Myers Squibb/Pfizer EE
30 APIXABAN ELIQUIS 5 mg Comprimé pelliculé B/60 Bristol-Myers Squibb/Pfizer EE
31 APIXABAN ELIQUIS 2,5mg Comprimé pelliculé B/20 Bristol-Myers Squibb/Pfizer EE
32 APIXABAN ELIQUIS 2,5mg Comprimé pelliculé B/60 Bristol-Myers Squibb/Pfizer EE
33 CRIZOTINIB XALKORI 250 mg Gélule FL/60 Pfizer Inc USA
34 CRIZOTINIB XALKORI 200 mg Gélule FL/60 Pfizer Inc USA
35 NEBIVOLOL+HYDROCHLOROTHIAZIDE NEBILET PLUS 5mg/12,5mg Comprimé pelliculé B/28 MENARINI INTERNATIONAL OPERATION Luxembourg S,A
36 NEBIVOLOL+HYDROCHLOROTHIAZIDE NEBILET PLUS 5mg/25mg Comprimé pelliculé B/28 MENARINI INTERNATIONAL OPERATION Luxembourg S,A
37 OLIGO-ELEMENTS NUTRYLET   Solution injectable pour perfusion B/10Ampoules/10ml AGUETTANT
38 AMLODIPINE-BISOPROLOL CONCOR AMLO 5mg/5mg Comprimé B/30 MERCK KFT HUNGARY
39 AMLODIPINE-BISOPROLOL CONCOR AMLO 5mg/10mg Comprimé B/30 MERCK KFT HUNGARY
40 AMLODIPINE-BISOPROLOL CONCOR AMLO 10mg/5mg Comprimé B/30 MERCK KFT HUNGARY
41 AMLODIPINE-BISOPROLOL CONCOR AMLO 10mg/10mg Comprimé B/30 MERCK KFT HUNGARY
42 TAMSULOSINE OMNIC OCAS 0,4mg Comprimé LP B/30 ASTELLAS PHARMA EUROPE B,V HOLLANDE
43 ANASTRAZOLE AVOMIN 1mg Comprimé pelliculé B/28 GENEPHARM
44 FESOTERODINE FUMARATE TOVIAZ 4mg Comprimé LP B/28 PFIZER Limited UK
45 FESOTERODINE FUMARATE TOVIAZ 8mg Comprimé LP B/28 PFIZER Limited UK
46 MESALAZINE PENTASA 1gr Granules a  liberation prolong B/50 FERRING Gmbh
47 MESALAZINE PENTASA 1gr Suppositoire B/30 FERRING Gmbh
48 ERTAPENEM INVANZ 1gr pdre pour prep inj B/1FL/20ML Merck Sharp & Dohme Ltd R.U
49 ALGINATES+BICARBONATE DE POTASSIUM GAVISCON ADVANCE   sups buvable B/250ml RECKITT BENCKISER HEALTHCARE UK LIMITED
50 ALGINATES+CARBONATE DE CALCIUM+BICARBONATE DE SODIUM GAVISCON DOUBLE ACTION LIQUID   sups buvable B/12Sachets/10ml RECKITT BENCKISER HEALTHCARE UK LIMITED
51 ALGINATES+CARBONATE DE CALCIUM+BICARBONATE DE SODIUM GAVISCON DOUBLE ACTION    comprimé à croquer B/16 RECKITT BENCKISER HEALTHCARE UK LIMITED
52 ALGINATES+CARBONATE DE CALCIUM+BICARBONATE DE SODIUM GAVISCON DOUBLE ACTION MINT   sups buvable FL/150ml RECKITT BENCKISER HEALTHCARE UK LIMITED
53 ALLERGENES STALORAL 10, 100, 300 IR/ml Gouttes buvables C/3FL/10ML STALLERGENES S.A.S
54 ALLERGENES STALORAL 300 IR/ml Gouttes buvables C/1FL/10ML STALLERGENES S.A.S
55 EXTRAITS ALLERGENIQUES ALUSTAL 0,01à10IR ou IC/ML Susp,injectable FL/5ML STALLERGENES S.A.S
56 DESMOPRESSINE MINIRIN 120µg Lyophilisat oral B/30 FERRING Gmbh
57 TIOTROPIUM SPIRIVA RESPIMAT  2.5µG/DOSE Sol pour inhalation B/1Inhalateur1cartouche de 60 doses BOEHRINGER INGELHEIM PHARMA GmbH &Co KG
58 MENOTRIPINE MENOPUR 600UI Pdre.prep.inj B/1FL+seringue pré-remplie de solvant FERRING-LECIVA
59 MENOTRIPINE MENOPUR 1200UI Pdre.prep.inj B/1FL+2 seringues pré-remplie de solvant FERRING-LECIVA
60 ESOMEPRAZOLE NEXUS 40mg pdre.prep.inj B/1FL HIKMA PHARMACEUTICALS
61 ROPIVACAINE ROPIVACAINE  KABI 5 mg/ml Solution injectable B/5 ampoules/10 ml FRESENIUS KABI FRANCE
62 TOFACITINIB XELJANZ 5 mg Comprimé pelliculé B/60 Pfizer Inc USA
63 BISMUTH +METRONIDAZOLE+TETRACYCLINE PYLERA 125mg/125mg/140mg Gélule B/1fl/120 AXCAN Pharma US. Inc
64 AMLODIPINE+VALSARTAN EXFORGE 5MG/80MG Comprimé pelliculé B/28 NOVARTIS PHARMA SCHWEIZ AG
65 AMLODIPINE+VALSARTAN EXFORGE. 5 mg/160mg Comprimé pelliculé B/28 NOVARTIS PHARMA SCHWEIZ AG
66 AMLODIPINE+VALSARTAN EXFORGE 10MG/160MG Comprimé pelliculé B/28 NOVARTIS PHARMA SCHWEIZ AG
67 ROSUVASTATINE CRESTOR 5 mg Comprimé pelliculé B/30 ASTRA ZENECA
68 ROSUVASTATINE CRESTOR 10 mg Comprimé pelliculé B/30 ASTRA ZENECA
69 ROSUVASTATINE CRESTOR 20 mg Comprimé pelliculé B/30 ASTRA ZENECA
70 FUROSEMIDE LASILIX SPECIAL 250 MG Solution injectable B/6/25 ML SANOFI-AVENTIS FRANCE
71 SOLIFENACINE SUCCINATE Vesicare 5 mg Comprimé pelliculé B/30 ASTELLAS PHARMA EUROPE  B.V HO
72 SOLIFENACINE SUCCINATE Vesicare 10 mg Comprimé pelliculé B/30 ASTELLAS PHARMA EUROPE  B.V HO
73 EXTRAITS ALLERGENIQUES ORALAIR 100 IR & 300 IR Comprime sublingual B/3 comprimésde 100 IR + 28 co STALLERGENES S.A.S
74 EXTRAITS ALLERGENIQUES ORALAIR 300 IR Comprime sublingual B/30 comprimés de 300 IR STALLERGENES S.A.S
75 ORNITHINE CETORNAN 5 GR Poudre pour solution orale B/10 SACHETS CHIESI S.A
76 Bosentan (monohydrate) TRACLEER 62.5 mg Comprimé pelliculé B/56 cp ACTELION PHARMACEUTICALS LTD
77 Bosentan (monohydrate) TRACLEER 125 mg Comprimé pelliculé B/56 cp ACTELION PHARMACEUTICALS LTD
78 POLYVIDONE IODEE BETADINE 10% Gel dermique T/100 gr MEDA PHARMA
79 TACROLIMUS ADVAGRAF LP 3 mg Gélule à libération prolongée B/100 HIKMA Pharmaceuticals
80 TACROLIMUS ADVAGRAF LP 0,5 mg Gélule à libération prolongée B/100 HIKMA Pharmaceuticals
81 TACROLIMUS ADVAGRAF LP 1 mg Gélule à libération prolongée B/100 HIKMA Pharmaceuticals
82 TACROLIMUS ADVAGRAF LP 5 mg Gélule à libération prolongée B/100 HIKMA Pharmaceuticals
83 Golimumab SIMPONI 50 MG Solution injectable B/1 Seringue Pré-remplie JANSSEN BIOLOGICS B.V
84 Golimumab SIMPONI 50 MG Solution injectable B/1 Stylo Pré-rempli JANSSEN BIOLOGICS B.V
85 ETANERCEPT ENBREL 50 mg Solution injectable B/4 stylos pré-remplis PFIZER Limited UK
86 ETANERCEPT ENBREL 25 mg Solution injectable B/4 ser. pré-remplies/0.5 ml PFIZER Limited UK
87 CERTOLIZUMAB CIMZIA 200 mg Solution injectable B/2 seringues/ml +2 tampons al UCB PHARMA SA  BELGIQUE
88 TACILIZUMAB ACTEMRA 200 mg/10 ml Solution injectable pour perfu B/1FL/4 ml ROCHE PHARMA (SCHWEIZ) LTD SUI
89 TACILIZUMAB ACTEMRA 400 mg/20 ml Solution injectable pour perfu B/1FL/20 ml ROCHE PHARMA (SCHWEIZ) LTD SUI
90 TACILIZUMAB ACTEMRA 80 mg/4 ml Solution injectable pour perfu B/1FL/20 ml ROCHE PHARMA (SCHWEIZ) LTD SUI
91 CIPROFLOXACINE UFEXIL 200 mg/100ml Solution injectable pour perfu FL/100 ml DEMO SA
92 INTERFERON BETA-1A REBIF 22µg Solution injectable B/12 stylo prérempli MERCK SERONO EUROPE Limited UK
93 INTERFERON BETA-1A REBIF 44µg Solution injectable B/12 stylo prérempli MERCK SERONO EUROPE Limited UK
94 ANASTROZOLE ANASTRAZOLE ZAPHYR PHARMACEUTI 1 mg Comprimé pelliculé B/28 ZAPHYR PHARMACEUTICALS IRELAND
95 FER INOFER 100mg/ 100mg Comprimé pelliculé B/25 LISAPHARM
96 IBRUTINIB IMBRUVICA 140 mg Gélule B/90 Janssen-Cilag International 
97 IBRUTINIB IMBRUVICA 140 mg Gélule B/120 Janssen-Cilag International 
98 IMATINIB IMATINIB ZENTIVA 100 mg Comprimé pelliculé B/120 ZENTIVA KS
99 IMATINIB IMATINIB ZENTIVA 400 mg Comprimé pelliculé B/30 SANOFI AVENTIS CYPRUS LTD
100 EPIRUBICINE EPIRUBICIN THYMOORGAN 10 mg/5 ml Solution injectable pour perfu B/1 flacon/5 ml HIKMA Pharmaceuticals
101 EPIRUBICINE EPIRUBICIN THYMOORGAN 50 mg/25 ml Solution injectable pour perfu B/1 flacon/25 ml HIKMA Pharmaceuticals
102 EPIRUBICINE EPIRUBICIN THYMOORGAN 200 mg/100 ml Solution injectable pour perfu B/1 flacon/100 ml HIKMA Pharmaceuticals
103 IRINOTECAN IRINOTECAN MYLAN 20 mg/ml (40mg) Solution injectable pour perfu B/1FL/2 ml MYLAN S.A.S
104 IRINOTECAN IRINOTECAN MYLAN 20 mg/ml (100mg) Solution injectable pour perfu B/1FL/5 ml MYLAN S.A.S
105 IRINOTECAN IRINOTECAN MYLAN 20 mg/ml (300mg) Solution injectable pour perfu B/1FL/15 ml MYLAN S.A.S
106 TOPOTECAN TOPOTECAN KABI 1mg/ml Pdre p.prep.injectable B/ 1 flacon FRESENIUS KABI ONCOLOGY PLC
107 IMIPENEM+CILASTATINE IMIPENEM/CILASTATINE HOSPIRA 500 mg/500 mg Pdre p.prep.injectable B/5 Flacon/20 ml HOSPIRA UK Limited
108 VANCOMYCINE VANCOMYCINE MYLAN 500 mg Pdre p.prep.injectable B/1 flacon MYLAN S.A.S
109 EXEMESTANE EXEMESTANE ACCORD 25 mg Comprimé pelliculé B/30 ACCORD HEALTHCARE LTD
110 Bosentan (monohydrate) pms-Bosentan 62.5 mg Comprimé B/60 cp PHARMASCIENCE INC CANADA
111 Bosentan (monohydrate) pms-Bosentan 125 mg Comprimé B/60 cp PHARMASCIENCE INC CANADA
112 TAFLUPROST SAFLUTAN 15 mcg/ml Collyre B/30 unidoses/0.3 ml Merck Sharp & Dohme France
113 DOCETAXEL CYTOTERE 20mg Solution injectable pour perfu B/1FL/1ml CYTOPHARMA
114 DOCETAXEL CYTOTERE 80 mg / 4 ml Solution injectable pour perfu B/1FL/4 ml CYTOPHARMA
115 EPIRUBICINE CYTOBICINE 10 mg/5 ml Solution injectable pour perfu B/1FL/5 ml CYTOPHARMA
116 EPIRUBICINE CYTOBICINE 50 mg/25 ml Solution injectable pour perfu B/1FL/25 ml CYTOPHARMA
117 NORADRENALINE NORADRENALINE MEDIS (sans cons 2mg/ml Solution injectable pour perfu B/10/4 ml MEDIS
118 FUROSEMIDE FUROLIX Spécial 250 mg/25ml Solution injectable B/5/25 ml MEDIS
119 CICLOSPORINE IMMUPRY100 100 mg/ml Solution buvable FL/50 ml TAHA PHARMA
120 ACICLOVIR ACICLOVIR WEST 5% Creme dermique T/5 GR WEST PHARMA
121 ACICLOVIR ACICLOVIR WEST 200 MG Comprimé B/30 WEST PHARMA
122 ACICLOVIR ACICLOVIR WEST 200 mg/5ML Suspension buvable FL/125 ML WEST PHARMA
123 ACICLOVIR ACICLOVIR WEST 800 mg/ 10ml Suspension buvable FL/125 ML WEST PHARMA
124 ATORVASTATINE ATOR 20 mg Comprimé pelliculé B/28 MEDIS
125 ATORVASTATINE ATOR 80 mg Comprimé pelliculé B/28 MEDIS
126 CAPTOPRIL+HYDROCHLORTHIAZIDE CO-TENSOPRIL 50 mg/25 mg Comprimé B/30 DAR-ESSAYDALI.
127 AMOXICILLINE+ACIDE CLAVULANIQUE AMOXI-CLAV ZENTIVA 1000 mg/125 mg Poudre p. suspension orale B/24 Sachets WINTHROP PHARMA TUNISIE
128 IRBESARTAN+HYDROCHLOROTHIAZIDE CO-ARADEUX 150 mg/12.5 mg Comprimé pelliculé B/90 SAIPH
129 IRBESARTAN+HYDROCHLOROTHIAZIDE CO-ARADEUX 300 mg/12.5 mg Comprimé pelliculé B/90 SAIPH
130 IRBESARTAN+HYDROCHLOROTHIAZIDE CO-ARADEUX 300 mg/25 mg Comprimé pelliculé B/90 SAIPH
131 QUETIAPINE QUETAP 25 mg Comprimé pelliculé B/60 PHILADELPHIA PHARMA
132 QUETIAPINE QUETAP 50 mg Comprimé pelliculé B/60 PHILADELPHIA PHARMA
133 QUETIAPINE QUETAP 100 mg Comprimé pelliculé B/60 PHILADELPHIA PHARMA
134 QUETIAPINE QUETAP 200 mg Comprimé pelliculé B/60 PHILADELPHIA PHARMA
135 QUETIAPINE QUETAP 300 mg Comprimé pelliculé B/60 PHILADELPHIA PHARMA
136 PRIFINIUM FRIDIAL Enfant   Solution buvable FL/50 ml TERIAK
137 MEPIVACAINE+NOR-ADRENALINE NORMEDICAINE 2% AVEC NORADRENA   Solution injectable B/50 Carpules/1.8ML MEDIS
138 GLIMEPIRIDE GLITRA 1 mg Comprimé B/90 SAIPH
139 GLIMEPIRIDE GLITRA 2 MG Comprimé sécable B/90 SAIPH
140 GLIMEPIRIDE GLITRA 3 mg Comprimé sécable B/90 SAIPH
141 GLIMEPIRIDE GLITRA 4 mg Comprimé sécable B/90 SAIPH
142 MYCOPHENOLATE MOFETIL MEFIL 500 mg Comprimé pellicullé B/60 SIMED