Dossiers d'AMM à étudier par le Comité Technique des Spécialités Pharmaceutiques du 18/04/2018.
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 | LATAZ 0,005% | LATANOPROST | 50 mcg/ml | Collyre | FL/2.5 ML | RAFARM SA |
| 2 | LATAZ 0CO | LATANOPROST+TIMOLOL | Collyre | FL/2.5 ML | RAFARM SA | |
| 3 | OPTODROP-CO | DORZOLAMIDE +TIMOLOL | Collyre | FL/5 ML | RAFARM SA | |
| 4 | AUBAGIO | TERIFLUNOMIDE | COMPRIME PELLICULE | B/28 | SANOFI AVENTIS | |
| 5 | SMOFKABIVEN E | SOLUTION ACIDES AMINES | 1600Kcal | EMULSION PERFUSION | B/4 POCHES | FRESENIUS KABI France |
| 6 | SMOFKABIVEN E | SOLUTION ACIDES AMINES | 1100Kcal | EMULSION PERFUSION | B/4 POCHES | FRESENIUS KABI France |
| 7 | SMOFKABIVEN E | SOLUTION ACIDES AMINES | 2200Kcal | EMULSION PERFUSION | B/4 POCHES | FRESENIUS KABI France |
| 8 | FRAGOR | DELAPRIDE+MANIDIPINE | 30mg+10mg | COMPRIME | B/28 | CHIESI Italie |
| 9 | DIANEAL PD4 | GLUCOSE+ELECTROLYTES | 2,27 | SOL DIALYSE PERI | POCHE 2L | BAXTER UK |
| 10 | DIANEAL PD4 | GLUCOSE+ELECTROLYTES | 1,36 | SOL DIALYSE PERI | POCHE 5L | BAXTER UK |
| 11 | DIANEAL PD4 | GLUCOSE+ELECTROLYTES | 1,36 | SOL DIALYSE PERI | POCHE 2L | BAXTER UK |
| 12 | DIANEAL PD4 | GLUCOSE+ELECTROLYTES | 2,27 | SOL DIALYSE PERI | POCHE 5L | BAXTER UK |
| 13 | DIANEAL PD4 | GLUCOSE+ELECTROLYTES | 3.86 | SOL DIALYSE PERI | POCHE 2L | BAXTER UK |
| 14 | BICALUTAMIDE ACCORD | BICALUTAMIDE | 50MG | COMPRIME PELLICULE | B/28 | ACCORD HAELTHCARE |
| 15 | OFEV | NINTEDANIB | 100mg | CAPSULE MOLLE | B/60 | BOEHRINGER |
| 16 | OFEV | NINTEDANIB | 150mg | CAPSULE MOLLE | B/60 | BOEHRINGER |
| 17 | OPDIVO | NIVOLUMAB | 100 mg/10 ml | SOL INJECTABLE | B/1FL/4ml | BMS |
| 18 | OPDIVO | NIVOLUMAB | 100 mg/10 ml | SOL INJECTABLE | B/1FL/10ml | BMS |
| 19 | EFIENT | PRASUGREL | 5MG | COMPRIME | B/28 | DAIICHI SANKYO EUROPE |
| 20 | EFIENT | PRASUGREL | 10MG | COMPRIME | B/28 | DAIICHI SANKYO EUROPE |
| 21 | VIGAMOX | MOXIFLOXACINE | 5MG/ML | COLLYRE | FL/5ML | ALCON |
| 22 | TRESIBA FLEXTACH | INSULINE DEGLUDEC | 100 U/ML | stylos préremplis de 3 ml | B/3 | NOVO NORDISK A/S |
| 23 | TRESIBA FLEXTACH | INSULINE DEGLUDEC | 200 U/ ML | stylos préremplis de 3 ml | B/3 | NOVO NORDISK A/S |
| 24 | ORFADIN | NITISINONE | 4MG/ML | SUSP ORALE | FL/90ML | SOBI |
| 25 | ORFADIN | NITISINONE | 20MG | gelule | FL/60 | SOBI |
| 26 | KIVEXA | ABACAVIR/LAMIVUDINE | 600/300MG | COMPRIME PELLICULE | B/30 | VIIV HAETHCARE |
| 27 | SURVANTA | BERACTANT | 100mg/4ml | susp,intrachéale | FL/8ML | ABBVIE CORPORATION |
| 28 | SURVANTA | BERACTANT | 200mg/8ml | susp,intrachéale | FL/8ML | ABBVIE CORPORATION |
| 29 | ALYOSTAL PRICK-TEST CONTRÔLE POSITIF | HISTAMINE HCL | SOLUTION AQUEUSE | FL/3ML | STALLERGENE SA | |
| 30 | ALYOSTAL PRICK-TEST TEMOIN NEGATIF | TEMOIN NEGATIF | SOLUTION AQUEUSE | FL/3ML | STALLERGENE SA | |
| 31 | ALYOSTAL PRICK | EXTRAIT ALLERGENIQUE | SOLUTION AQUEUSE | FL/3ML | STALLERGENE SA | |
| 32 | PIPERACILLINE TAZOBACTAM KABI | PIPERACILLINE TAZOBACTAM | 2GR/250MG | PDRE,INJ,PERF | B/10FL | FREISINUS KABI |
| 33 | PIPERACILLINE TAZOBACTAM KABI | PIPERACILLINE TAZOBACTAM | 2GR/250MG | PDRE,INJ,PERF | B/10FL | FREISINUS KABI |
| 34 | OZURDEX | DEXAMETHASONE | 700MCG | SOL.INTRAOCULAIRE | B/1 IMPLANT | MEDICIS |
| 35 | OLOPAT | OLOPATADINE | 0,001 | COLLYRE | B/1FL/5ML | JAMJOUM PHARMA |
* Produits à évaluer pour la première fois au Comité Technique
| N° | Médicament | DCI | Dosage | Forme Pharmaceutique | Présentation | TITULAIRE |
| 1 | STELARA | USTEKINUMAB | 45MG/0,5ML | SOL INJ | B/1FL | JANSSEN-CILAG |
| 2 | STELARA | USTEKINUMAB | 45MG/0,5ML | SOL INJ | B/1 SERINGUE PRE-REMPLIE | JANSSEN-CILAG |
| 3 | STELARA | USTEKINUMAB | 90MG/ML | SOL INJ | B/1 SERINGUE PRE-REMPLIE | JANSSEN-CILAG |
| 4 | HYALOSILVER | HYALURONATE DE SODIUM | 0,002 | PDRE USAGE EXTERNE | FL/125ML | FIDIA PHARMACEUTICAL |
| 5 | ALDURAZYME | LARONIDASE | 100U/ML | CONCENTRE STERILE | B/1FL | GENZYME |
| 6 | EPIDUO | ADAPALENE+PEROXYDE DE BENZOYLE | 0,1%+2,5% | GEL | FL/30GR | GALDERMA |
| 7 | MEROPENEM KABI | MEROPENEME TRIHYDRATE | 1GR | SOL,INJ | B/10FL/20ML | FREISINIUS KABI |
| 8 | FACTANE | FACTEUR VIII | 1000UI/5ML | LYOPHILISAT SOL INJ | B/+1FL SLVT | LFB-BIOMEDICAMENT |
| 9 | FACTANE | FACTEUR VIII | 2000UI/10ML | LYOPHILISAT SOL INJ | B/+1FL SLVT | LFB-BIOMEDICAMENT |
| 10 | SINOVIAL | HYALURONATE DE SODIUM | 16MG/2ML | SOL INJ | B/3 SERINGUES | IBSA FARMACEUTICI |
| 11 | NEBILET | NEBIVOLOL | 5MG | COMPRIME SECABLE | B/30 | MENARINI SA |
| 12 | PROLUTEX | PROGESTERONE | 25MG | SOL INJ | B/7FL | IBSA SUISSE |
| 13 | MOONIA | DESOGESTREL | 75µG | COMPRIME | B/28 | STRAGEN UK |
| 14 | FLUTIFORM | FLUTICASONE+FORMOTEROL | 125µG/5µG | SUSP. INHAL | B/1FL/120DOSES | NAPP PHARMACEUTICAL |
| 15 | FLUTIFORM | FLUTICASONE+FORMOTEROL | 50µG/5µG | SUSP. INHAL | B/1FL/120DOSES | NAPP PHARMACEUTICAL |
| 16 | HUMIRA | ADALILUMAB | 40MG | SOL.INJECTABLE | B/2SERINGUES/0,4ML | ABBVIE |
| 17 | BIOMAG ARGUMES | PRDTS HOMEOPATHIQUES | COMPRIME CROQUER | B/90 | LEHNING | |
| 18 | OSCILLOCOCCINUM 200 | PRDTS HOMEOPATHIQUES | GRANULES | B/6 | BOIRON | |
| 19 | OSCILLOCOCCINUM 200 | PRDTS HOMEOPATHIQUES | GRANULES | B/3 | BOIRON | |
| 20 | MERCURE SOL COMPLEXE N°39 | PRDTS HOMEOPATHIQUES | COMPRIME SUBLINGUAL | B/60 | LEHNING | |
| 21 | BISEPTINE | BENZALKONIUM+CHLORH | SOLUTION EXTERNE | FL/100ML | BAYER France | |
| 22 | MONTELUKAST SANDOZ | MONTELUKAST | 5MG | COMPRIME A CROQUER | B/28 | SANDOZ FRANCE |
| 23 | MONTELUKAST SANDOZ | MONTELUKAST | 10MG | COMPRIME A CROQUER | B/28 | SANDOZ FRANCE |
| 24 | EYEFILL MB | HYALURONATE DE SODIUM | SOL INTRAOCULAIRE | B/2 SERINGUES | VALENT POLAND | |
| 25 | EYEFILL C | HYALURONATE DE SODIUM | SOL INTRAOCULAIRE | B/2 SERINGUES | VALENT POLAND | |
| 26 | SINUSPAX | COMPRIME A CROQUER | B/60 | LEHNING France | ||
| 27 | PABAL | CARBETOCINE | 100MCG/ML | SOL INJ | B/5FL | FERRING GMBH |
| 28 | VICTOZA | LIRAGLUTIDE | 6MG/ML | SOL INJ | B/2 STYLOS | NOVO NORDISK |
| 29 | NATEMILLE | VIT D3 | 600MG/1000UI | COMP ORODISPERSIBLE | B/30 | ITALFARMACO |
| 30 | RYZODEG FLEXTOUCH | INSULINE ASPARTATE+INSULINE DEGLUDEC | 100UI/ML | SOL INJ | B/5 STYLOS/3ML | NOVO NORDISK |
| 31 | REVOLADE | ELTROMBOPAG | 25MG | COMP PELLICULES | B/28 | NOVARTIS EUROPHARM LIMITED |
| 32 | REVOLADE | ELTROMBOPAG | 50MG | COMP PELLICULES | B/28 | NOVARTIS EUROPHARM LIMITED |
| 33 | MINIRIN | ACETATE DESMOPRESSINE | 10UG | SOL PULV NASALE | FL/5ML | FERRING GERMANY |
| 34 | MINIRIN | ACETATE DESMOPRESSINE | 60UG | LYOPHILISAT ORALE | B/30 | FERRING GERMANY |
