Dossiers d'AMM ŕ étudier par le Comité Technique des Spécialités Pharmaceutiques du 12/07/2017.

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

Spécialités Pharmaceutiques importées :

* Produits déjŕ évalués lors des derniers Comités Techniques

DCI Médicament Dosage Forme Pharmaceutique Présentation TITULAIRE
1 SILDENAFIL  VIAGRA ODT 50MG Comprimé Orodispersible B/8 PFIZER LTD UK
2 SILDENAFIL  VIAGRA ODT 50MG Comprimé Orodispersible B/2 PFIZER LTD UK
3 SILDENAFIL  VIAGRA ODT 50MG Comprimé Orodispersible B/4 PFIZER LTD UK
4 LEVITERACETAM EPIXX 250MG COMPRIME B/50 ABDI IBRAHIM
5 LEVITERACETAM EPIXX 500MG COMPRIME B/50 ABDI IBRAHIM
6 MONTELUKAST ONCEAIR 4MG GRANULES EN SACHET B/28 ABDI IBRAHIM
7 MONTELUKAST ONCEAIR 5MG COMPRIME B/28 ABDI IBRAHIM
8 MONTELUKAST ONCEAIR 10MG COMPRIME B/28 ABDI IBRAHIM
9 AFLIBERCEPT    EYLEA 40 mg/ml     SOLUTION INJECTABLE FL/ 100 µl BAYER PHARMA AG     
10 LATANAPROST OFTAGEN 0,00005 COLLYRE FL/2,5ML ABDI IBRAHIM
11 APOMORPHINE APOKINON 30MG SOLUTION INJECTABLE B/1 STYLO/3ML AGUETTANT
12 APOMORPHINE APOKINON 30MG SOLUTION INJECTABLE B/5 STYLO/3ML AGUETTANT

* Produits ŕ évaluer pour la premičre fois au Comité Technique

DCI Médicament Dosage Forme Pharmaceutique Présentation TITULAIRE
1 UMECLIDENUM/VILANTEROL ANORO   PDRE,INHAL B/1 GSK UK
2 BECLOMETHASONE/FORMOTEROL FOSTER 100/6µg SOL,INHAL B/1FL CHIESI
3 TIOTROPIUM SPIRIVA RESPIMAT 2,5µg SOL,INHAL B/1FL BOEHRINGER ING.INT.GmbH
4 GATIFLOXACINE ZYMAXID 0,005 SOL,OPHTAL B/1FL/2,5ML ALLERGAN SALES/USA
5 PEGINTERFERON BETA-1A PLEGRIDY 63µg+94µg SOL,INJ B/2STYLOS/0,5ML BIOGEN IDEC
6 PEGINTERFERON BETA-1A PLEGRIDY 125µg SOL,INJ B/2STYLOS/0,5ML BIOGEN IDEC
7 GLUCONATE FERREUX+GLUCONATE DE MANGANESE+GLUCONATE DE CUIVRE TOT'HEMA   SOL,BUVABLE B/20AMPOULES INNOTECH INTERNATIONAL France
8 MIRTAZAPINE MIRATAZAPINE  SANDOZ 15MG COMPRIME B/30 SANDOZ France
9 ERYTHROMYCINE+ACETATE DE ZINC ZINERYT 40MG/1ML/12MG/ML LOTION FL/30ML ASTELLAS PHARMA EUROPE BV
10 DULOXETINE CYMBALTA 30MG GELULES B/28 ELI LILLY
11 DULOXETINE CYMBALTA 60MG GELULES B/28 ELI LILLY
12 ACIDE ACETYL-SALICYLIQUE ASPIRINE PROTECT 100MG COMPRIME  B/30 BAYER SAS
13 BETAMETHASONE BETESIL 2,25MG EMPLATRE B/8 GENEVRIER S.A
14 TIOTROPIUM+OLODATEROL SPILOTO RESPIMAT 2,5µG/2,5µG SOLUTION A INHALER B/1FL BOEHRINGER ING.INT.GmbH
15 MESALAZINE PENTASA 500MG COMPRIME LP B/100 FERRING GMBH
16 POVIDONE IODEE+ETHANOL BETADINE ALCOLIQUE 0,05 SOLUTION FL/125ML MEDA PHARMA
17 POVIDONE IODEE+ETHANOL BETADINE ALCOLIQUE 0,05 SOLUTION FL/500ML MEDA PHARMA
18 LEUPRORELINE ELIGARD 22,5MG PDRE+SOLVANT SOL,INJ B/1FL ASTELLAS PHARMA EUROPE BV
19 LEUPRORELINE ELIGARD 45MG PDRE+SOLVANT SOL,INJ B/1FL ASTELLAS PHARMA EUROPE BV
20 FACTEUR WILLEBRAND HUMAIN WILFACTIN 500 UI PDRE PREP INJ B/1FLPDRE+SOLVT/5ML+SET TRANSFERT LFB-BIOMEDICAMENT
21 FACTEUR VIII KOGENATE-FS 250UI PDRE PREP INJ B/1FL+SLVT/2,5ML BAYER HC LLC US
22 FACTEUR VIII KOGENATE-FS 500UI PDRE PREP INJ B/1FL+SLVT/2,5ML BAYER HC LLC US
23 FACTEUR VIII KOGENATE-FS 1000UI PDRE PREP INJ B/1FL+SLVT/2,5ML BAYER HC LLC US
24 RUXOLITINIB JAKAVI 5MG COMPRIME B/56 NOVARTIS PHARMA SCHWEIZ AG
25 RUXOLITINIB JAKAVI 15MG COMPRIME B/56 NOVARTIS PHARMA SCHWEIZ AG
26 RUXOLITINIB JAKAVI 20MG COMPRIME B/56 NOVARTIS PHARMA SCHWEIZ AG
27 IBUPROFENE/PSEUDOEPHEDRINE IBUGESIC COLD AND SINUS  200/30 MG COMPRIME PELLICULE B/20 DAR AL DAWA
28 SEKINUMAB COSENTYX 15MG/ML SERINGUE PRE-REMPLIE B/2 NOVARTIS EUROPHARM R,U
29 SEKINUMAB COSENTYX 15MG/ML STYLOS PRE-REMPLIE B/2 NOVARTIS EUROPHARM R,U
30 DICLOFENAC ITAMI 140MG EMPLATRE B/5 FIDIA Italie
31 TIAPRIDE TIAPRIDAL 100MG SOLUTION INJECTABLE B/12/2ML SANOFI-AVENTIS FRANCE
32 TIAPRIDE TIAPRIDAL 100MG COMPRIME SECABLE B/20 SANOFI-AVENTIS FRANCE
33 IMMUNOGLOBULINE HUMAINE NORMALE TEGELINE 2,5GR/50ML POUDRE+SOLVANT POUR PERFUSION FL/50ML LFB-BIOMEDICAMENT
34 IMMUNOGLOBULINE HUMAINE NORMALE TEGELINE 5GR/100ML POUDRE+SOLVANT POUR PERFUSION FL/100ML LFB-BIOMEDICAMENT
35 IMMUNOGLOBULINE HUMAINE NORMALE TEGELINE 10GR/200ML POUDRE+SOLVANT POUR PERFUSION FL/100ML LFB-BIOMEDICAMENT
36 MIOCAMYCINE MIOCAMEN 250MG/ML POUDRE,SUSP,ORALE FL/120ML MENARINI Italie
37 MIOCAMYCINE MIOCAMEN 250MG/ML POUDRE,SUSP,ORALE FL/120ML MENARINI Italie
38 CHLORHYDRATE DE TRAMADOL+PARACETAMOL ZALDIAR 37,5/326MG COMPIME PELLICULE B/20 GRUNENTHAL GMBH Allemagne
39 TÉMOZOLOMIDE TEGOZOL  20 mg Gélule B/5 HIKMA Pharmaceuticals
40 TÉMOZOLOMIDE TEGOZOL  100 mg Gélule B/5 HIKMA Pharmaceuticals
41 RANOLAZINE RANEXA 375MG COMPRIME LP B/60 MENARINI LUXEMBURG
42 RANOLAZINE RANEXA 500MG COMPRIME LP B/60 MENARINI LUXEMBURG
43 RANOLAZINE RANEXA 750MG COMPRIME LP B/60 MENARINI LUXEMBURG
44 EZETINIBE+SIMVASTATINE INEGY 10MG/20MG COMPRIME B/28 MSD
45 EZETINIBE+SIMVASTATINE INEGY 10MG/40MG COMPRIME B/28 MSD
46 PRASUGEL EFIENT 5MG COMPRIME PELLICULE B/28 DAICHI SANKYO GMBH
47 PRASUGEL EFIENT 10MG COMPRIME PELLICULE B/28 DAICHI SANKYO GMBH
48 SACUBITRIL ENTRESTO 50MG COMPRIME PELLICULE B/56 NOVARTIS PAHRAMA
49 SACUBITRIL ENTRESTO 100MG COMPRIME PELLICULE B/56 NOVARTIS PAHRAMA
50 SACUBITRIL ENTRESTO 200MG COMPRIME PELLICULE B/56 NOVARTIS PAHRAMA
51 METFORMINE  METFORMINE ZENTIVA 1000 mg COMPRIME PELLICULE B/30 SANOFI AVENTIS France
52 BENDAMUSTINE HCL BENDAVIVAL 100MG LYOPHILISAT,PREP,INJ B/1FL/20ML HIKMA JORDANIE
53 DOXAZOSINE   CARDULAR PP URO 4 MG COMPRIME LP B/30 PFIZER Allemagne
54 AMLODIPINE+VALSARTAN LOTEVAN 5mg/160mg COMPRIME B/30 TABUK
55 AMLODIPINE+VALSARTAN LOTEVAN 10mg/160mg COMPRIME B/30 TABUK
56  ACIDE HYALURONIQUE HYALOSILVER 0,20% SPRAY EN POUDRE FL/50ML FIDIA Italie
57 INDOMETACINE INDOCOLLYRE 0,10% COLLYRE B/20 RECIPIENTS UNIDOSES CHAUVIN France
58 PASIREOTIDE DIASPARTATE SIGNIFOR 0,3mg SOL,INJECTABLE B/30 AMPOULES/1 ML NOVARTIS AG SUISSE
59 PASIREOTIDE DIASPARTATE SIGNIFOR 0,6mg SOL,INJECTABLE B/30 AMPOULES/1 ML NOVARTIS AG SUISSE
60 PASIREOTIDE DIASPARTATE SIGNIFOR 0,9mg SOL,INJECTABLE B/30 AMPOULES/1 ML NOVARTIS AG SUISSE
61 AZELASTINE CHLORHYDRATE ALLERGODIL 0,05% COLLYRE FL/6ML MEDA PHARMA
62 DAPOXETINE HYDROCHLORIDE PRILIGY 30mg COMPRIME PELLICULE B/3 MENARINI ITALY
63 DAPOXETINE HYDROCHLORIDE PRILIGY 60mg COMPRIME PELLICULE B/3 MENARINI ITALY
64 BERACTANT SURVENTA 100MG/4ML SUSPENSION INTRACHEALE FL/4ML ABBVIE-CANADA
65 BERACTANT SURVENTA 200MG/8ML SUSPENSION INTRACHEALE FL/8ML ABBVIE-CANADA
66 TUROCTOGOG ALPHA NOVOEIGHT 3000UI/ML LYOPHILISAT+SOLVANT B/1FL+SOLVANT NOVO-NORDISK DANEMARK
67 TUROCTOGOG ALPHA NOVOEIGHT 2000UI/ML LYOPHILISAT+SOLVANT B/1FL+SOLVANT NOVO-NORDISK DANEMARK
68 TUROCTOGOG ALPHA NOVOEIGHT 1500UI/ML LYOPHILISAT+SOLVANT B/1FL+SOLVANT NOVO-NORDISK DANEMARK
69 TUROCTOGOG ALPHA NOVOEIGHT 1000UI/ML LYOPHILISAT+SOLVANT B/1FL+SOLVANT NOVO-NORDISK DANEMARK
70 TUROCTOGOG ALPHA NOVOEIGHT 500UI/ML LYOPHILISAT+SOLVANT B/1FL+SOLVANT NOVO-NORDISK DANEMARK
71 TUROCTOGOG ALPHA NOVOEIGHT 250UI/ML LYOPHILISAT+SOLVANT B/1FL+SOLVANT NOVO-NORDISK DANEMARK
72 RANIBIZUMAB LUCENTIS 10MG/ML Solution injectable B/1FL/0,23ML NOVARTIS PHARMA SCHWEIZ AG
73 GLUCOSAMINE STRUCTOFLEX 650MG GELULE B/60 PIERRE FABRE France
74 PITAVASTATINE LIVAZO 2MG COMPRIME B/28 ALGORITHM-LIBAN
75 PITAVASTATINE LIVAZO 4MG COMPRIME B/28 ALGORITHM-LIBAN
76 LIRAGLUTIDE VICTOZA 6mg/ml SOLUTION INJECTABLE B/2 STYLOS NOVO NORDISK
77 INSULINE ANALOGUE NOVORAPID FLEXPEN 100UI/ML SOLUTION INJECTABLE B/5 STYLOS PRE-REMPLIES NOVO NORDISK
78 INSULINE ANALOGUE LEVEMIR FLEXPEN 100UI/ML SOLUTION INJECTABLE B/5 STYLOS PRE-REMPLIES NOVO NORDISK
79 LINAGLEPTINE TRAJENTA 5MG COMPRIME PELLICULE B/28 BOEHRINGER ING.INT.GmbH
80 LINAGLEPTINE+METFORMINE JENTADUETO 2,5/850MG COMPRIME PELLICULE B/56 BOEHRINGER ING.INT.GmbH
81 LINAGLEPTINE+METFORMINE JENTADUETO 2,5/1000MG COMPRIME PELLICULE B/56 BOEHRINGER ING.INT.GmbH
82 APREPITANT EMEND 125 mg+80mg GELULE B/3 MSD UK
83 BACILLUS CLAUSII  ENTEROGERMINA 2 MILLIARDS GELULE B/12 SANOFI Italie
84 NINTEDANIB VARGATEF 100mg capsules molles B/60 BOEHRINGER ING.INT.GmbH
85 NIVOLUMAB OPDIVO 10mg/ml SOLUTION PERF B/1FL/10ML BMS-UK
86 SOLUTION ACIDES AMINES SMOFKABIVEN E  1600Kcal EMULSION PERFUSION B/4 POCHES FRESENIUS KABI France
87 SOLUTION ACIDES AMINES SMOFKABIVEN E  1100Kcal EMULSION PERFUSION B/4 POCHES  FRESENIUS KABI France
88 SOLUTION ACIDES AMINES SMOFKABIVEN E  2200Kcal EMULSION PERFUSION B/4 POCHES FRESENIUS KABI France