Dossiers d'AMM à étudier par le Comité Technique des Spécialités Pharmaceutiques du 23/08/2017.

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

Spécialités Pharmaceutiques importées :

* Produits déjà évalués lors des derniers Comités Techniques

DCI Médicament Dosage Forme Pharmaceutique Présentation TITULAIRE
1 GATIFLOXACINE ZYMAXID 0,005 SOL,OPHTAL B/1FL/2,5ML ALLERGAN SALES/USA
2 TIOTROPIUM+OLODATEROL SPILOTO RESPIMAT 2,5µG/2,5µG SOLUTION A INHALER B/1FL BOEHRINGER ING.INT.GmbH
3 PICOSULFATE DE SODIUM+OXYDE DE MAGNÉSIUM LÉGER+ACIDE CITRIQU PICOPREP   PDRE SOL ORLAE B/2 sachets FERRING S.A.S
4 TOPOTECAN TOPOTECAN KABI 1mg/ml PDRE PREP INJ B/ 1 flacon FRESENIUS KABI ONCOLOGY PLC
5 DARBEPOETIN ALFA ARANESP 30 mcg/0.3ml SOLUTION INJECTABLE B/4 Seringues pré-remplies/0.3 AMGEN EUROPE B.V
6 DARBEPOETIN ALFA ARANESP 40 mcg/0.4ml SOLUTION INJECTABLE B/4 Seringues Seringues pré-re AMGEN EUROPE B.V
7 DARBEPOETIN ALFA ARANESP 20 mcg/0.5ml SOLUTION INJECTABLE B/4 Seringues pré-remplies/0.5 AMGEN EUROPE B.V
8 DARBEPOETIN ALFA ARANESP 60 mcg/0.3ml SOLUTION INJECTABLE B/4 Seringues pré-remplies/0.3 AMGEN EUROPE B.V
9 DARBEPOETIN ALFA ARANESP 10 mcg/0.4ml SOLUTION INJECTABLE B/4 Seringues pré-remplies/0.4 AMGEN EUROPE B.V
10 DARBEPOETIN ALFA ARANESP 50 mcg/0.5ml SOLUTION INJECTABLE B/4 Seringues pré-remplies/0.5 AMGEN EUROPE B.V
11 DROPERIDOL DROPERIDOL AGUETTANT 1.25 mg/ml SOLUTION INJECTABLE B/10/Ampoules/1ml AGUETTANT
12 TROPICAMIDE+PHENYLEPHRINE MYDRIASERT 0.28 mg/5.40 mg IMPLANT B/20 THEA
13 INSULINE DEGLUDEC TRESIBA FLEXTOUCH 100 U/ ML SOLUTION INJECTABLE B/5 stylos préremplis de 3 ml NOVO NORDISK A/S
14 INSULINE DEGLUDEC TRESIBA FLEXTOUCH 200 U/ ML SOLUTION INJECTABLE B/3 stylos préremplis de 3 ml NOVO NORDISK A/S
15 IMMUNOGLOBULINE HUMAINE POLYVALENTE HIZENTRA 2 gr SOLUTION INJECTABLE FL/10ML CSL Behring AG
16 IMMUNOGLOBULINE HUMAINE POLYVALENTE HIZENTRA 1 gr SOLUTION INJECTABLE FL/5ML CSL Behring AG
17 IMMUNOGLOBULINE HUMAINE POLYVALENTE HIZENTRA 4 gr SOLUTION INJECTABLE FL/4ML CSL Behring AG
18 VEMURAFENIB ZELBORAF 240 mg COMPRIME B/56 ROCHE PHARMA (SCHWEIZ) LTD SUI
19 CANAKINUMAB ILARIS 150 mg/ml PDRE PREP INJ B/1 flacon NOVARTIS PHARMA SCHWEIZ AG
20 APOMORPHINE APOKINON 30MG SOLUTION INJECTABLE B/1 STYLO/3ML AGUETTANT
21 AFLIBERCEPT ZALTRAP 25mg/ml  SOLUTION INJECTABLE Fl/4ml  SANOFI AVENTIS
22 AFLIBERCEPT ZALTRAP 25mg/ml  SOLUTION INJECTABLE Fl/4ml  SANOFI AVENTIS
23 KETOROLAC TROMETHAMINE ACUVAIL 0,004 COLLYRE B/30 ALLERGAN Inc
24 APOMORPHINE APOKINON 30MG SOLUTION INJECTABLE B/5 STYLO/3ML AGUETTANT
25 PHENYLEPHRINE PHENYLEPHRINE AGUETTANT 50µg/ml sol inj B/10 SERINGUES/10ML AGUETTANT
26 BENDAMUSTINE LEVACT  25mg PDRE PREP INJ B/5FL ASTELLAS
27 BENDAMUSTINE LEVACT  100mg PDRE PREP INJ B/5FL ASTELLAS
28   ROTATEQ   SOL BUVABLE B/1 UNIDOSE MSD
29 TÉMOZOLOMIDE TEMODAL 5 mg Gélule B/5 Merck Sharp & Dohme Ltd R.U
30 TÉMOZOLOMIDE TEMODAL 100 mg Gélule B/5 Merck Sharp & Dohme Ltd R.U
31 TÉMOZOLOMIDE TEMODAL 20 mg Gélule B/5 Merck Sharp & Dohme Ltd R.U
32 TÉMOZOLOMIDE TEMODAL 180 mg Gélule B/5 Merck Sharp & Dohme Ltd R.U
33 TÉMOZOLOMIDE TEMODAL 250 mg Gélule B/5 MSD Ltd
34 TACROLIMUS TACROLIMUS HEXAL 1mg GELULE B/100 HEXAL AG
35 TACROLIMUS TACROLIMUS HEXAL 5mg GELULE B/100 HEXAL AG
36 METFORMINE METFORMINE MYLAN PHARMA 850 MG Comprimé pelliculé B/90 MYLAN S.A.S
37 METFORMINE METFORMINE MYLAN PHARMA 850 MG Comprimé pelliculé B/30 MYLAN S.A.S
38 BUDESONIDE CORTIMENT MMX 9mg Comprimé LP B/20 Ferring Germany
39 DEXAMETHASONE OZURDEX 700 µg IMPLANT b/1 Allergan irland

* Produits à évaluer pour la première fois au Comité Technique

DCI Médicament Dosage Forme Pharmaceutique Présentation TITULAIRE
1 RUXOLITINIB JAKAVI 5MG COMPRIME B/56 NOVARTIS PHARMA SCHWEIZ AG
2 RUXOLITINIB JAKAVI 15MG COMPRIME B/56 NOVARTIS PHARMA SCHWEIZ AG
3 RUXOLITINIB JAKAVI 20MG COMPRIME B/56 NOVARTIS PHARMA SCHWEIZ AG
4 IBUPROFENE/PSEUDOEPHEDRINE IBUGESIC COLD AND SINUS  200/30 MG COMPRIME PELLICULE B/20 DAR AL DAWA
5 SEKINUMAB COSENTYX 15MG/ML SERINGUE PRE-REMPLIE B/2 NOVARTIS EUROPHARM R,U
6 SEKINUMAB COSENTYX 15MG/ML STYLOS PRE-REMPLIE B/2 NOVARTIS EUROPHARM R,U
7 DICLOFENAC ITAMI 140MG EMPLATRE B/5 FIDIA Italie
8 TIAPRIDE TIAPRIDAL 100MG SOLUTION INJECTABLE B/12/2ML SANOFI-AVENTIS FRANCE
9 TIAPRIDE TIAPRIDAL 100MG COMPRIME SECABLE B/20 SANOFI-AVENTIS FRANCE
10 IMMUNOGLOBULINE HUMAINE NORMALE TEGELINE 2,5GR/50ML POUDRE+SOLVANT POUR PERFUSION FL/50ML LFB-BIOMEDICAMENT
11 IMMUNOGLOBULINE HUMAINE NORMALE TEGELINE 5GR/100ML POUDRE+SOLVANT POUR PERFUSION FL/100ML LFB-BIOMEDICAMENT
12 IMMUNOGLOBULINE HUMAINE NORMALE TEGELINE 10GR/200ML POUDRE+SOLVANT POUR PERFUSION FL/100ML LFB-BIOMEDICAMENT
13 MIOCAMYCINE MIOCAMEN 250MG/ML POUDRE,SUSP,ORALE FL/120ML MENARINI Italie
14 MIOCAMYCINE MIOCAMEN 250MG/ML POUDRE,SUSP,ORALE FL/120ML MENARINI Italie
15 CHLORHYDRATE DE TRAMADOL+PARACETAMOL ZALDIAR 37,5/326MG COMPIME PELLICULE B/20 GRUNENTHAL GMBH Allemagne
16 TÉMOZOLOMIDE TEGOZOL  20 mg Gélule B/5 HIKMA Pharmaceuticals
17 TÉMOZOLOMIDE TEGOZOL  100 mg Gélule B/5 HIKMA Pharmaceuticals
18 RANOLAZINE RANEXA 375MG COMPRIME LP B/60 MENARINI LUXEMBURG
19 RANOLAZINE RANEXA 500MG COMPRIME LP B/60 MENARINI LUXEMBURG
20 RANOLAZINE RANEXA 750MG COMPRIME LP B/60 MENARINI LUXEMBURG
21 EZETINIBE+SIMVASTATINE INEGY 10MG/20MG COMPRIME B/28 MSD
22 EZETINIBE+SIMVASTATINE INEGY 10MG/40MG COMPRIME B/28 MSD
23 PRASUGEL EFIENT 5MG COMPRIME PELLICULE B/28 DAICHI SANKYO GMBH
24 PRASUGEL EFIENT 10MG COMPRIME PELLICULE B/28 DAICHI SANKYO GMBH
25 SACUBITRIL ENTRESTO 50MG COMPRIME PELLICULE B/56 NOVARTIS PAHRAMA
26 SACUBITRIL ENTRESTO 100MG COMPRIME PELLICULE B/56 NOVARTIS PAHRAMA
27 SACUBITRIL ENTRESTO 200MG COMPRIME PELLICULE B/56 NOVARTIS PAHRAMA
28 METFORMINE  METFORMINE ZENTIVA 1000 mg COMPRIME PELLICULE B/30 SANOFI AVENTIS France
29 BENDAMUSTINE HCL BENDAVIVAL 100MG LYOPHILISAT,PREP,INJ B/1FL/20ML HIKMA JORDANIE
30 DOXAZOSINE   CARDULAR PP URO 4 MG COMPRIME LP B/30 PFIZER Allemagne
31 AMLODIPINE+VALSARTAN LOTEVAN 5mg/160mg COMPRIME B/30 TABUK
32 AMLODIPINE+VALSARTAN LOTEVAN 10mg/160mg COMPRIME B/30 TABUK
33  ACIDE HYALURONIQUE HYALOSILVER 0,20% SPRAY EN POUDRE FL/50ML FIDIA Italie
34 INDOMETACINE INDOCOLLYRE 0,10% COLLYRE B/20 RECIPIENTS UNIDOSES CHAUVIN France
35 PASIREOTIDE DIASPARTATE SIGNIFOR 0,3mg SOL,INJECTABLE B/30 AMPOULES/1 ML NOVARTIS AG SUISSE
36 PASIREOTIDE DIASPARTATE SIGNIFOR 0,6mg SOL,INJECTABLE B/30 AMPOULES/1 ML NOVARTIS AG SUISSE
37 PASIREOTIDE DIASPARTATE SIGNIFOR 0,9mg SOL,INJECTABLE B/30 AMPOULES/1 ML NOVARTIS AG SUISSE
38 AZELASTINE CHLORHYDRATE ALLERGODIL 0,05% COLLYRE FL/6ML MEDA PHARMA
39 DAPOXETINE HYDROCHLORIDE PRILIGY 30mg COMPRIME PELLICULE B/3 MENARINI ITALY
40 DAPOXETINE HYDROCHLORIDE PRILIGY 60mg COMPRIME PELLICULE B/3 MENARINI ITALY
41 BERACTANT SURVENTA 100MG/4ML SUSPENSION INTRACHEALE FL/4ML ABBVIE-CANADA
42 BERACTANT SURVENTA 200MG/8ML SUSPENSION INTRACHEALE FL/8ML ABBVIE-CANADA
43 TUROCTOGOG ALPHA NOVOEIGHT 3000UI/ML LYOPHILISAT+SOLVANT B/1FL+SOLVANT NOVO-NORDISK DANEMARK
44 TUROCTOGOG ALPHA NOVOEIGHT 2000UI/ML LYOPHILISAT+SOLVANT B/1FL+SOLVANT NOVO-NORDISK DANEMARK
45 TUROCTOGOG ALPHA NOVOEIGHT 1500UI/ML LYOPHILISAT+SOLVANT B/1FL+SOLVANT NOVO-NORDISK DANEMARK
46 TUROCTOGOG ALPHA NOVOEIGHT 1000UI/ML LYOPHILISAT+SOLVANT B/1FL+SOLVANT NOVO-NORDISK DANEMARK
47 TUROCTOGOG ALPHA NOVOEIGHT 500UI/ML LYOPHILISAT+SOLVANT B/1FL+SOLVANT NOVO-NORDISK DANEMARK
48 TUROCTOGOG ALPHA NOVOEIGHT 250UI/ML LYOPHILISAT+SOLVANT B/1FL+SOLVANT NOVO-NORDISK DANEMARK
49 RANIBIZUMAB LUCENTIS 10MG/ML Solution injectable B/1FL/0,23ML NOVARTIS PHARMA SCHWEIZ AG
50 GLUCOSAMINE STRUCTOFLEX 650MG GELULE B/60 PIERRE FABRE France
51 PITAVASTATINE LIVAZO 2MG COMPRIME B/28 ALGORITHM-LIBAN
52 PITAVASTATINE LIVAZO 4MG COMPRIME B/28 ALGORITHM-LIBAN
53 LIRAGLUTIDE VICTOZA 6mg/ml SOLUTION INJECTABLE B/2 STYLOS NOVO NORDISK
54 INSULINE ANALOGUE NOVORAPID FLEXPEN 100UI/ML SOLUTION INJECTABLE B/5 STYLOS PRE-REMPLIES NOVO NORDISK
55 INSULINE ANALOGUE LEVEMIR FLEXPEN 100UI/ML SOLUTION INJECTABLE B/5 STYLOS PRE-REMPLIES NOVO NORDISK
56 LINAGLEPTINE TRAJENTA 5MG COMPRIME PELLICULE B/28 BOEHRINGER ING.INT.GmbH
57 LINAGLEPTINE+METFORMINE JENTADUETO 2,5/850MG COMPRIME PELLICULE B/56 BOEHRINGER ING.INT.GmbH
58 LINAGLEPTINE+METFORMINE JENTADUETO 2,5/1000MG COMPRIME PELLICULE B/56 BOEHRINGER ING.INT.GmbH
59 APREPITANT EMEND 125 mg+80mg GELULE B/3 MSD UK
60 BACILLUS CLAUSII  ENTEROGERMINA 2 MILLIARDS GELULE B/12 SANOFI Italie
61 NINTEDANIB VARGATEF 100mg capsules molles B/60 BOEHRINGER ING.INT.GmbH
62 NIVOLUMAB OPDIVO 10mg/ml SOLUTION PERF B/1FL/10ML BMS-UK
63 SOLUTION ACIDES AMINES SMOFKABIVEN E  1600Kcal EMULSION PERFUSION B/4 POCHES FRESENIUS KABI France
64 SOLUTION ACIDES AMINES SMOFKABIVEN E  1100Kcal EMULSION PERFUSION B/4 POCHES  FRESENIUS KABI France
65 SOLUTION ACIDES AMINES SMOFKABIVEN E  2200Kcal EMULSION PERFUSION B/4 POCHES FRESENIUS KABI France
66 BICALUTAMIDE BICALUTAMIDE ACCORD 50 mg comprimé pelliculé B/28 Accord Healthcare RU
67 HYALURONATE DE SODIUM AMVISC PLUS 0,016 PREP.VISOCOELASTIQUE B/1 SERINGUE/0.8ML BAUSCH LOMB USA
68 EPIRUBICIN EPIRUBICIN MYLAN 2mg/ml sol,perfusion B/1FL/5ML MYLAN SAS France
69 EPIRUBICIN EPIRUBICIN MYLAN 2mg/ml sol,perfusion B/1FL/25ML MYLAN SAS France
70 EPIRUBICIN EPIRUBICIN MYLAN 2mg/ml sol,perfusion B/1FL/100ML MYLAN SAS France
71 XYLOMETAZOLINE HYDROCHLORIDE 0.1% DECOSAL 0,10% SPRAY NASAL B/1 FL/10ML AMMAN PHARMACEUTICAL INDUSTRIES JORDAN 
72 MESALAZINE PENTASA 1 GR COMPRIME B/60 FERRING GMBH GERMANY
73 PIPERACILLINE+ TAZOBACTAM PIPERACILLINE TAZOBACTAM MYLAN 4GR/500MG PDRE SOL PERF B/1FL MYLAN SAS France
74 PIPERACILLINE+ TAZOBACTAM PIPERACILLINE TAZOBACTAM MYLAN 2GR/250MG PDRE SOL PERF B/1FL MYLAN SAS France