Dossiers d'AMM à étudier par le Comité Technique des Spécialités Pharmaceutiques du 06/06/2018.
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 | 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 | SANDOSTATINE LAR | OCTREOTIDE | 10MG | PDRE SUSP INJ | B/1FL+SRGUE | NOVARTIS PHARMA SUISSE |
| 5 | SANDOSTATINE LAR | OCTREOTIDE | 20MG | PDRE SUSP INJ | B/1FL+SRGUE | NOVARTIS PHARMA SUISSE |
| 6 | SANDOSTATINE LAR | OCTREOTIDE | 30MG | PDRE SUSP INJ | B/1FL+SRGUE | NOVARTIS PHARMA SUISSE |
| 7 | JAKAVI | RUXOLITINIB | 5MG | COMPRIME | B/56 | NOVARTIS PHARMA SUISSE |
| 8 | JAKAVI | RUXOLITINIB | 15MG | COMPRIME | B/56 | NOVARTIS PHARMA SUISSE |
| 9 | JAKAVI | RUXOLITINIB | 20MG | COMPRIME | B/56 | NOVARTIS PHARMA SUISSE |
| 10 | IMBRUVICA | IBRUTINIB | 140MG | GELULE | B/90 | JANSSEN CILAG |
| 11 | APOKINON | APOMORPHINE | 30MG | SOLUTION INJECTABLE | B/1 STYLO/3ML | AGUETTANT |
| 12 | APOKINON | APOMORPHINE | 30MG | SOLUTION INJECTABLE | B/5 STYLO/3ML | AGUETTANT |
| 13 | PERJETA | PERTUZUMAB | 420MG/14ML | SOL INJ PERFUSION | B/1FL | ROCHE PHARMA |
* Produits à évaluer pour la première fois au Comité Technique
| N° | Médicament | DCI | Dosage | Forme Pharmaceutique | Présentation | TITULAIRE |
| 1 | ZINNAT | CEFUROXIME | 500MG | COMPRIME PELLICULLES | B/10 | GSK BELGIQUE |
| 2 | PROLUTEX | PROGESTERONE | 25MG | SOL INJ | B/7FL | IBSA SUISSE |
| 3 | MOONIA | DESOGESTREL | 75µG | COMPRIME | B/28 | STRAGEN UK |
| 4 | FLUTIFORM | FLUTICASONE+FORMOTEROL | 125µG/5µG | SUSP. INHAL | B/1FL/120DOSES | NAPP PHARMACEUTICAL |
| 5 | FLUTIFORM | FLUTICASONE+FORMOTEROL | 50µG/5µG | SUSP. INHAL | B/1FL/120DOSES | NAPP PHARMACEUTICAL |
| 6 | ALDARA | IMIQUIMOD | 5% | SACHETS | B/12 | MEDA PHARMA |
| 7 | HUMIRA | ADALILUMAB | 40MG | SOL.INJECTABLE | B/2SERINGUES/0,4ML | ABBVIE |
| 8 | BIOMAG ARGUMES | PRDTS HOMEOPATHIQUES | COMPRIME CROQUER | B/90 | LEHNING | |
| 9 | OSCILLOCOCCINUM 200 | PRDTS HOMEOPATHIQUES | GRANULES | B/6 | BOIRON | |
| 10 | OSCILLOCOCCINUM 200 | PRDTS HOMEOPATHIQUES | GRANULES | B/3 | BOIRON | |
| 11 | MERCURE SOL COMPLEXE N°39 | PRDTS HOMEOPATHIQUES | COMPRIME SUBLINGUAL | B/60 | LEHNING | |
| 12 | BISEPTINE | BENZALKONIUM+CHLORH | SOLUTION EXTERNE | FL/100ML | BAYER France | |
| 13 | MONTELUKAST SANDOZ | MONTELUKAST | 5MG | COMPRIME A CROQUER | B/28 | SANDOZ FRANCE |
| 14 | MONTELUKAST SANDOZ | MONTELUKAST | 10MG | COMPRIME A CROQUER | B/28 | SANDOZ FRANCE |
| 15 | EYEFILL MB | HYALURONATE DE SODIUM | SOL INTRAOCULAIRE | B/2 SERINGUES | VALENT POLAND | |
| 16 | EYEFILL C | HYALURONATE DE SODIUM | SOL INTRAOCULAIRE | B/2 SERINGUES | VALENT POLAND | |
| 17 | SINUSPAX | COMPRIME A CROQUER | B/60 | LEHNING France | ||
| 18 | PABAL | CARBETOCINE | 100MCG/ML | SOL INJ | B/5FL | FERRING GMBH |
| 19 | VICTOZA | LIRAGLUTIDE | 6MG/ML | SOL INJ | B/2 STYLOS | NOVO NORDISK |
| 20 | NATEMILLE | VIT D3 | 600MG/1000UI | COMP ORODISPERSIBLE | B/30 | ITALFARMACO |
| 21 | RYZODEG FLEXTOUCH | INSULINE ASPARTATE+INSULINE DEGLUDEC | 100UI/ML | SOL INJ | B/5 STYLOS/3ML | NOVO NORDISK |
| 22 | REVOLADE | ELTROMBOPAG | 25MG | COMP PELLICULES | B/28 | NOVARTIS EUROPHARM LIMITED |
| 23 | REVOLADE | ELTROMBOPAG | 50MG | COMP PELLICULES | B/28 | NOVARTIS EUROPHARM LIMITED |
| 24 | MINIRIN | ACETATE DESMOPRESSINE | 60UG | LYOPHILISAT ORALE | B/30 | FERRING GERMANY |
| 25 | OXYNORM | OXYCODONE HCL | 5MG | GELULE | B/56 | NAPP PHARMACEUTICAL |
| 26 | OXYNORM | OXYCODONE HCL | 10MG | GELULE | B/56 | NAPP PHARMACEUTICAL |
| 27 | OXYNORM | OXYCODONE HCL | 20MG | GELULE | B/56 | NAPP PHARMACEUTICAL |
| 28 | CERVARIX | VACCIN CONTRE PAPILLOMAVIRUS HUMAIN | 20µG/20µG | SUSP.INJ | B/1 SERINGUE PREREMPLIE | GSK |
| 29 | MONURIL | FOSFOMYCINE | 3GR | GRANULES SUPS BUVABLE | B/1 SACHET | ZAMBON |
| 30 | COLIMYCINE | COLISTINEMETHANESULFONATE SODIQUE | 1000000UI | PDRE SUSP INJ | B/50 | SANOFI AVENTIS France |
| 31 | BOOSTRIX | VACCIN DIPHTERIQUE TETANIQUE COQUELUCHEUX | SUSP INJ | B/1 SERINGUE PREREMPLIE | GSK Belgique | |
| 32 | IMMUNO HBS | IMMUNOGLOBULINE HUMAINE ANTI HBS | 180 UI | SOL INJ | B/1 FL/1ML | KEDRION SPA |
| 33 | IMMUNO HBS | IMMUNOGLOBULINE HUMAINE ANTI HBS | 540UI | SOL INJ | B/1 FL/3ML | KEDRION SPA |
| 34 | HEPATITIS B | IMMUNOGLOBULINE HUMAINE ANTI HBS | 200 UI | SOL INJ | B/1 SERINGUE PREREMPLIE | CSL BEHRING GERMANY |
| 35 | HEPATITIS B | IMMUNOGLOBULINE HUMAINE ANTI HBS | 200 UI | SOL INJ | B/1 SERINGUE PREREMPLIE | CSL BEHRING GERMANY |
| 36 | NIMENRIX | SOL INJ | B/1 SERINGUE PREREMPLIE | PFIZER UK | ||
| 37 | TRIBESTAN | EXTRAIT SEC DE TRIBULIS | 250MG | COMPRIME | B/60 | SO PHARMA BULGARIE |
| 38 | LETROZLE MYLAN | LETROZLE | 2,5MG | COMPRIME PELLICULLES | B/30 | MYLAN SAS France |
| 39 | LEXAVON | LEVOFLOXACINE | 5MG/ML | COLLYRE | B/1FL | RAFARM SA GRECE |
| 40 | DBL GEMCITABINE | GEMCITABINE | 200MG/5,3ML | SOL PERF | B/1FL | HOSPIRA PTY |
| 41 | DBL GEMCITABINE | GEMCITABINE | 1GR/26,3ML | SOL PERF | B/1FL | HOSPIRA PTY |
| 42 | PMS-PREGABALINE | PREGABALINE | 75MG | GELULE | B/100 | PMS CANADA |
| 43 | PMS-PREGABALINE | PREGABALINE | 150MG | GELULE | B/100 | PMS CANADA |
| 44 | EYLEA | AFLIBERCEPT | 40MG/ML | SOL,INJ | B/1FL/120DOSES | BAYER Allemagne |
| 45 | GC FLU | VACCIN ANTIGRIPPE | SOL INJ | B/1 Seringue pré-rempli | GREEN CROSS CORPORATION | |
| 46 | GC FLU | VACCIN ANTIGRIPPE | SOL INJ | B/1 Seringue pré-rempli | GREEN CROSS CORPORATION | |
| 47 | BLISSEL | ESTRIOL | 50µg/gr | GEL VAGINAL | T/10gr+10 canules | ITALFARMACO ESPANGE |
| 48 | ASMANEX TWISTHALER | FUROATE DE MOMETASONE | 200µG/DOSE | PDRE,INHAL | FL/30 DOSES | MSD France |
| 49 | ASMANEX TWISTHALER | FUROATE DE MOMETASONE | 200µG/DOSE | PDRE,INHAL | FL/60 DOSES | MSD France |
| 50 | MEROPENEM | MEROPENEME TRIHYDRATE | 500MG | PDRE SOL INJ | B/10FL | HOSPIRA UK |
| 51 | MEROPENEM | MEROPENEME TRIHYDRATE | 1GR/26,3ML | PDRE SOL INJ | B/10FL | HOSPIRA UK |
| 52 | HALDOL DECANOAS | HALOPERIDOL | 50MG | SOL INJ | B/1FL/1ML | JANSSEN CILAG |
| 53 | HALDOL DECANOAS | HALOPERIDOL | 50MG | SOL INJ | B/5FL/1ML | JANSSEN CILAG |
| 54 | HALDOL | HALOPERIDOL | 5MG/ML | SOL INJ | B/5FL/1ML | JANSSEN CILAG |
| 55 | HALDOL | HALOPERIDOL | 1MG | COMPRIME | B/40 | JANSSEN CILAG |
| 56 | FERINJECT | CARBOXYMALTOSE FERRIQUE | 50MG/ML | SOL INJ | B/1FL/10ML | HIKMA PHARMACEUTICAL |
| 57 | LIPIODOL ULTRA FLUIDE | HUILE D OEILETTE ESTERS ETHYL | 480 MG/ML | SOL INJ | B/1AMP/10ML | GUERBET |
| 58 | MORPHINE CHLORHYDRATE AGUETTANT | MORPHINE | 0,1MG/ML | SOL INJ | B/10AMP/5ML | AGUETTANT |
| 59 | DUROGESIC 12 | FENTANYL | 12µG/H | DISPOSITIF TRANSDERMIQUE | B/5 | JANSSEN CILAG |
| 60 | DUROGESIC 25 | FENTANYL | 25µG/H | DISPOSITIF TRANSDERMIQUE | B/5 | JANSSEN CILAG |
| 61 | DUROGESIC 50 | FENTANYL | 50µG/H | DISPOSITIF TRANSDERMIQUE | B/5 | JANSSEN CILAG |
| 62 | DUROGESIC 75 | FENTANYL | 75µG/H | DISPOSITIF TRANSDERMIQUE | B/5 | JANSSEN CILAG |
| 63 | DUROGESIC 100 | FENTANYL | 100µG/H | DISPOSITIF TRANSDERMIQUE | B/5 | JANSSEN CILAG |
| 64 | SIMPONI | GOLIMUMAB | 50 MG | SOL INJ | B/1 STYLO PR2E-REMPLI | JANSSEN CILAG |
| 65 | APROKAM | CEFUROXIME SODIQUE | 50MG | SOL INJ | B/10FL | THEA |
| 66 | STABLON | TIANEPTINE | 12,5 MG | COMPENROBE | B/28 | SERVIER |
| 67 | FINASTERIDE ACCORD | FINASTERIDE | 5MG/ML | COMPRIME PELLICULE | B/28 | ACCORD UK |
| 68 | TELMISERTAN KERN PHARMA | TELMISERTAN | 40MG | COMPRIME | B/28 | KERN PHARMA |
| 69 | TELMISERTAN KERN PHARMA | TELMISERTAN | 80MG | COMPRIME | B/28 | KERN PHARMA |
| 70 | ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE | 10MG/ML | SOL INJ | B/10FL/20ML | HOSPIRA CANADA |
| 71 | METHOTREXATE ACCORD | METHOTREXATE | 50MG (25MG/ML) | SOL INJ | B/10FL/2ML | ACCORD UK |
| 72 | METHOTREXATE ACCORD | METHOTREXATE | 500MG(25MG/ML) | SOL INJ | B/10FL/20ML | ACCORD UK |
| 73 | SINTROM | ACENOCOUMAROL | 4 MG | COMP SEC | B/20 | MEDIUS AG SUISSE |
