Dossiers d'AMM à étudier par le Comité Technique des Spécialités Pharmaceutiques du 10/07/2019.
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 | VEIC | Type de demande | DATE courrier |
1 | PRILIGY | DAPOXETINE | 30mg | comp pell | B/3 | MENARINI | N | 04/01/2019 | |
2 | PRILIGY | DAPOXETINE | 60mg | comp pell | B/3 | MENARINI | N | 04/01/2019 | |
3 | STELARA | USTEKINUMAB | 45MG | SOL INJ | B/1 SERINGUE | JANSSEN CILAG | E | N | CS 08/01/2019 |
4 | STELARA | USTEKINUMAB | 45 MG | SOL INJ | B/1FL | JANSSEN CILAG | E | N | CS 08/01/2019 |
5 | STELARA | USTEKINUMAB | 90MG | SOL INJ | B/1 SERINGUE | JANSSEN CILAG | E | N | CS 08/01/2019 |
6 | KEVESY | LEVETIRACETAM | 5MG/ML | SOL INJ PERFUSION | B/10 POCHES/100ML | STRAGEN | E | N | 18/01/2019 |
7 | KEVESY | LEVETIRACETAM | 10MG/ML | SOL INJ PERFUSION | B/10 POCHES/100ML | STRAGEN | E | N | 18/01/2019 |
8 | KEVESY | LEVETIRACETAM | 15MG/ML | SOL INJ PERFUSION | B/10 POCHES/100ML | STRAGEN | E | N | 18/01/2019 |
9 | TARGINACT | OXYCODINE HCL+NALOXONE HCL | 10/5MG | COMP LP | B/56 | NAPP PHARMACEUTICAL UK | V | N | 20/02/2019 |
10 | TARGINACT | OXYCODINE HCL+NALOXONE HCL | 20mg/10mg | COMP LP | B/56 | NAPP PHARMACEUTICAL UK | V | N | 20/02/2019 |
11 | TARGINACT | OXYCODINE HCL+NALOXONE HCL | 40/20MG | COMP LP | B/56 | NAPP PHARMACEUTICAL UK | V | N | 20/02/2019 |
12 | OFEV | NINTEDANIB | 150MG | CAPSULES MOLLES | B/60 | BOEHRINGER INGELHEIM | I | N | 06/03/2019 |
13 | PRAXBIND | IDARUCIZUMAB | 2,5G/50ML | SOL INJ PERFUSION | B/2FL/50ML | BOEHRINGER INGELHEIM | V | N | 15/03/2019 |
14 | PROLUTEX | PROGESTERONE | 25MG | SOL INJ | B/7FL | IBSA Institut Biochimique SA | N | 27/03/2019 | |
15 | ATACAND | Candesertan Cilexetil | 4mg | CP | B/30 | ASTRA ZENECA | E | V | 22/04/2019 |
16 | ATACAND | Candesertan Cilexetil | 8mg | CP | B/30 | ASTRA ZENECA | E | V | 22/04/2019 |
17 | ATACAND | Candesertan Cilexetil | 16mg | CP | B/30 | ASTRA ZENECA | E | V | 22/04/2019 |
18 | MIRVASO | BRIMONIDINE TARTRATE | 3mg/gr | Gel dermique | T / 30gr | GALDERMA INTERNATIONAL | C | N | 22/05/2019 |
19 | XARELTO | RIVAROXABAN | 15mg | Cp | B42 | BAYER | E | N | 29/05/2019 |
20 | XARELTO | RIVAROXABAN | 15mg | Cp | B28 | BAYER | E | N | 29/05/2019 |
21 | LUCENTIS | RANIBIZUMAB | 10MG/ML | SOL INJ | B/1FL | NOVARTIS | E | V | 27/06/2019 |
* Produits à évaluer pour la première fois au Comité Technique
N° | Médicament | DCI | Dosage | Forme Pharmaceutique | Présentation | TITULAIRE | VEIC | Type de la demande | DATE RE |
1 | ALDARA | IMIQUIMOD | 5% | CREME | B/12 | MEDA SUEDE | N | CS 08/01/2019 | |
2 | SIMPONI | GOLIMUMAB | 100MG | SOL INJ | B/1 STYLO | JANSSEN BV | V | N | CS 08/01/2019 |
3 | MENOPUR | MENOTROPINE | 75UI | PDRE+SLVT INJ | B/5FL | FERRING SAS | E | V | CS 08/01/2019 |
4 | COSOPT | DORZOLAMIDE/TIMOLOL | 20/5 MG/ML | COLLYRE | B/60 | MUNDIPHARMA AUSTRIA | N | Transfert 21/01/2019 | |
5 | DIATER POLYMERIZED | EXTRAIT ALLERGENIQUES | SOL INJ | B/1FL | DIATER | E | N | 22/01/2019 | |
6 | DIATER POLYMERIZED | EXTRAIT ALLERGENIQUES | SOL INJ | B/3FL | DIATER | E | N | 22/01/2019 | |
7 | STELARA | USTEKINUMAB | 130MG | SOL PERF | B/1FL/26ML | JANSSEN CILAG | N | 18/02/2019 | |
8 | AKYNZEO | NETUPITANT+PALONOSETRON | 300MG/0,5MG | GELULE | B/1 | HELSEIN BIREX | N | 27/02/2019 | |
9 | SUXAMETHONIUM CHLORID VUAB | SUXAMETHONIUM CHLORURE | 100MG | PDRE PREP INJ | B/1FL | VUAB PHARMA A/S | V | N | 27/02/2019 |
10 | VIEKIRAX | OMBITASVIR+PARITAPREVIR+RITONAVIR | 12,5/75/50MG | COMP PELLICULE | B/56 | ABBVIE DEUTSCHLAND | E | N | TRANSFERT 22/02/2019 |
11 | EXVIERA | DASABUVIR | 250MG | COMP PELLICULE | B/56 | ABBVIE DEUTSCHLAND | E | N | TRANSFERT 22/02/2019 |
12 | IBRANCE | PALBOCICLIB | 100MG | GELULE | FL/21 | PFIZER INC | V | N | CS 07/03/2019 |
13 | IBRANCE | PALBOCICLIB | 125MG | GELULE | FL/21 | PFIZER INC | V | N | CS 07/03/2019 |
14 | IBRANCE | PALBOCICLIB | 75MG | GELULE | FL/21 | PFIZER INC | V | N | CS 07/03/2019 |
15 | VOTRIENT | PAZOPANIB | 400MG | COMPRIME PELLICULE | FL/30 | NOVARTIS EUROPHARM | V | CS 07/03/2019 | |
16 | VOTRIENT | PAZOPANIB | 200MG | COMPRIME PELLICULE | FL/30 | NOVARTIS EUROPHARM | V | V | CS 07/03/2019 |
17 | ETOPOSIDE MYLAN | ETOPOSIDE | 100MG | SOL INJ | B/10/5ML | MYLAN SAS | V | V | CS 07/03/2019 |
18 | PERJETA | PERTUZUMAB | 420MG | SOL PERF | FL/14ML | ROCHE PHARMA | E | V | CS 07/03/2019 |
19 | DECAPEPTYL LP | TRIPTORELINE | 3MG | PDRE PREP INJ | B/1FL | IPSEN PHARMA | V | V | CS 07/03/2019 |
20 | DECAPEPTYL LP | TRIPTORELINE | 11,25MG | PDRE PREP INJ | B/1FL | IPSEN PHARMA | V | V | CS 07/03/2019 |
21 | LYNPARZA | OLAPARIB | 50MG | GELULE | B/112 | ASTRA ZENECA | V | N | CS 07/03/2019 |
22 | FASLODEX | FLUVESTRANT | 250MG | SOL INJ | B/2/5ML | ASTRA ZENENCA | V | V | CS 07/03/2019 |
23 | LONSURF | TRIFLURIDINE/TIPIRACIL | 15/6,14MG | COMPRIME PELLICULE | B/20 | SERVIER | V | N | CS 07/03/2019 |
24 | LONSURF | TRIFLURIDINE/TIPIRACIL | 20/8,19MG | COMPRIME PELLICULE | B/20 | SERVIER | V | N | CS 07/03/2019 |
25 | ZERBAXA | CEFTOLOZANE+TAZOBACTAM | 1gr/0.5gr | PDRE PERF | B/10FL/20ML | MSD | E | N | 01/04/2019 |
26 | BETAFERON | INTERFERON BETA 1B | 250µg/ML | PDRE PREP INJ | B/15 | BAYER | E | N | TRANSFERT 18/04/2019 |
27 | EYLEA | AFLIBERCEPT | 40 MG/ML | SUSP INH | B/1 | BAYER AG | N | Transfert 25/04/2019 | |
28 | REMIFENTANIL MYLAN | REMIFENTANYL | 5 MG | PDRE PREP INJ | B/10 FL | MYLAN SAS | E | V | CS 03/05/2019 |
29 | REMIFENTANIL MYLAN | REMIFENTANYL | 1 MG | PDRE PREP INJ | B/10 FL | MYLAN SAS | E | V | CS 03/05/2019 |
30 | SPIRIVA RESPIMAT | TIOTROPIUM | 2,5µG/dose | SOIH | B/1UNE CAROUCHE DE 60 DOSES | BOEHRINGER | E | V | CS 03/05/2019 |
31 | NICOPATCH | NICOTINE | 35MG/20 CM | TTS | B/28 | PIERRE FABRE | C | V | CS 03/05/2019 |
32 | NICOPATCH | NICOTINE | 35MG/20 CM | TTS | B/7 | PIERRE FABRE | C | V | CS 03/05/2019 |
33 | NICOPATCH | NICOTINE | 17,5 MG/10 CM | TTS | B/28 | PIERRE FABRE | C | V | CS 03/05/2019 |
34 | NICOPATCH | NICOTINE | 17,5 MG/10 CM | TTS | B/7 | PIERRE FABRE | C | V | CS 03/05/2019 |
35 | NICOPATCH | NICOTINE | 52,5 MG/30 CM | TTS | B/28 | PIERRE FABRE | C | V | CS 03/05/2019 |
36 | NICOPATCH | NICOTINE | 52,5 MG/30 CM | TTS | B/7 | PIERRE FABRE | C | V | CS 03/05/2019 |
37 | NICOPASS | NICOTINE | 2,5 MG | PASTILLES | B/12 | PIERRE FABRE | C | V | CS 03/05/2019 |
38 | NICOPASS | NICOTINE | 2,5 MG | PASTILLES | B/36 | PIERRE FABRE | C | V | CS 03/05/2019 |
39 | NICOPASS | NICOTINE | 2,5 MG | PASTILLES | B/36 | PIERRE FABRE | C | V | CS 03/05/2019 |
40 | NICOPASS | NICOTINE | 2,5 MG | PASTILLES | B/12 | PIERRE FABRE | C | V | CS 03/05/2019 |
41 | NICOPASS | NICOTINE | 1,5 MG | PASTILLES | B/12 | PIERRE FABRE | C | V | CS 03/05/2019 |
42 | NICOPASS | NICOTINE | 1,5 MG | PASTILLES | B/36 | PIERRE FABRE | C | V | CS 03/05/2019 |
43 | TWYNSTA | TELMISARTAN/AMLODIPINE | 80 MG/10 MG | COMPRIME | B/28 | BOEHRINGER | E | V | CS 03/05/2019 |
44 | TWYNSTA | TELMISARTAN/AMLODIPINE | 40 MG/5 MG | COMPRIME | B/28 | BOEHRINGER | E | V | CS 03/05/2019 |
45 | TWYNSTA | TELMISARTAN/AMLODIPINE | 80 MG/5 MG | COMPRIME | B/28 | BOEHRINGER | E | V | CS 03/05/2019 |
46 | TWYNSTA | TELMISARTAN/AMLODIPINE | 40 MG/10 MG | COMPRIME | B/28 | BOEHRINGER | E | V | CS 03/05/2019 |
47 | FRAXIPARINE | NADROPARINE CALCIUM | 5700 UI AXA/0,6ML | SOL INJ | B/2 | ASPEN PHARMA | E | V | CS 03/05/2019 |
48 | FRAXIPARINE | NADROPARINE CALCIUM | 2850 UI Axa | SOL INJ | B/2 | ASPEN PHARMA | E | V | CS 03/05/2019 |
49 | BECLOSPIN | BECLOMETASONE | 800 MG/2ML | SUSP INH | B/20 | CHIESI SAS | E | V | CS 03/05/2019 |
50 | BECLOSPIN | BECLOMETASONE | 400 MG/ML | SUSP INH | B/20 | CHIESI SAS | E | V | CS 03/05/2019 |
51 | LIDOCAINE ADRENALINE | CHLORHYDRATE DE LIDOCAINE /TARTRATE D'ADRENALINE | 20 MG/ML 0,005MG/ML | SOL INJ | B/10 | AGUETTANT France | E | V | CS 03/05/2019 |
52 | LIDOCAINE ADRENALINE | CHLORHYDRATE DE LIDOCAINE /TARTRATE D'ADRENALINE | 10 MG/ML 0,005MG/ML | SOL INJ | B/10 | AGUETTANT France | E | V | CS 03/05/2019 |
53 | XARELTO | RIVAROXABAN | 10 MG | COMPRIME | B/10 | BAYER Allemagne | T/V | CS 03/05/2019 | |
54 | XARELTO | RIVAROXABAN | 10 MG | COMPRIME | B/30 | BAYER Allemagne | T/V | CS 03/05/2019 | |
55 | EZETROL | EZETIMIBE | 10 MG | COMPRIME | B/28 | MSD-SP Ltd | E | V | CS 03/05/2019 |
56 | TAHOR | ATORVASTATINE | 80 MG | COMPRIME | B/30 | PFIZER France | E | V | CS 03/05/2019 |
57 | MENAVEN | HEPARINE SODIQUE | 1000UI/G | GEL DERMIQUE | T/60 GR | MENARINI | C | V | CS 03/05/2019 |
58 | COOLMETEC | OLMESARTAN MEDOXOMIL/HYDROCHLOROTHIAZIDE | 40 MG/12,5MG | COMPRIME | B/30 | DAIICHI SANKYO | E | V | CS 03/05/2019 |
59 | COOLMETEC | OLMESARTAN MEDOXOMIL/HYDROCHLOROTHIAZIDE | 40 MG/25MG | COMPRIME | B/30 | DAIICHI SANKYO | E | V | CS 03/05/2019 |
60 | LOVENOX | ENOXAPARINE | 8000 UI/0,8 ML | SOL INJ | B/2 | SANOFI AVENTIS | E | V | CS 03/05/2019 |
61 | LOVENOX | ENOXAPARINE | 6000 UI/0,6ML | SOL INJ | B/2 | SANOFI AVENTIS | E | V | CS 03/05/2019 |
62 | LOVENOX | ENOXAPARINE | 4000 UI/0,4ML | SOL INJ | B/2 | SANOFI AVENTIS | E | V | CS 03/05/2019 |
63 | LOVENOX | ENOXAPARINE | 2000 UI/0,2ML | SOL INJ | B/2 | SANOFI AVENTIS | E | V | CS 03/05/2019 |
64 | LOVENOX | ENOXAPARINE | 6000 UI/0,6ML | SOL INJ | B/10 | SANOFI AVENTIS | E | V | CS 03/05/2019 |
65 | LOVENOX | ENOXAPARINE | 4000 UI/0,4ML | SOL INJ | B/6 | SANOFI AVENTIS | E | V | CS 03/05/2019 |
66 | LOVENOX | ENOXAPARINE | 8000 UI/0,8ML | SOL INJ | B/10 | SANOFI AVENTIS | E | V | CS 03/05/2019 |
67 | LOVENOX | ENOXAPARINE | 2000 UI/0,2ML | SOL INJ | B/6 | SANOFI AVENTIS | E | V | CS 03/05/2019 |
68 | INNOHEP | TINZAPARINE SODIQUE | 3500 UI/0,35ML | SOL INJ | B/2 | LEO | E | V | CS 03/05/2019 |
69 | INNOHEP | TINZAPARINE SODIQUE | 14000 UI/0,7ML | SOL INJ | B/2 | LEO | E | V | CS 03/05/2019 |
70 | INNOHEP | TINZAPARINE SODIQUE | 18000 UI/0,9ML | SOL INJ | B/2 | LEO | E | V | CS 03/05/2019 |
71 | INNOHEP | TINZAPARINE SODIQUE | 2500 UI/0,25ML | SOL INJ | B/2 | LEO | E | V | CS 03/05/2019 |
72 | INNOHEP | TINZAPARINE SODIQUE | 10000 UI/0,5ML | SOL INJ | B/2 | LEO | E | V | CS 03/05/2019 |
73 | INNOHEP | TINZAPARINE SODIQUE | 4500 UI/0,45ML | SOL INJ | B/2 | LEO | E | V | CS 03/05/2019 |
74 | PICOPREP | PICOSULFATE DE SODIUM, OXYDE DE MAGNESIUM LEGER,ACIDE CITRIQUE ANHYDRE | 10,0MG/3,5G/12,0G | PDRE PR SOL BUV | B/02 SACHETS | FERRING ARZNEIMITTEL GmbH | E | T | Transfert 07/05/2019 |
75 | LIBLAB | EXTRAIT DE SEC DE FEUILLES DE LIERRE | 35,7 MG | COMPRIME A SUCER | B/20 | DAR EL DAWA | C | N | 10/05/2019 |
76 | RISDONE | RISPERIDONE | 1MG/ML | SOL BUVABLE | FL/60ML | DAR EL DAWA | E | N | 10/05/2019 |
77 | RISDONE | RISPERIDONE | 1 MG/ML | SOL BUVABLE | FL/30ML | DAR EL DAWA | E | N | 10/05/2019 |
78 | SOLUVIT | MELANGE DES VITAMINES HYDROSOLUBLES | LYOPHILISAT PREP INJ | b/10/10ML | FRESENIUS KABI | C | N | 10/05/2019 | |
79 | CERTICAN | EVEROLIMUS | 0,5 MG | COMPRIME | b/60 | NOVARTIS PHARMA | V | N | 13/05/2019 |
80 | SIMULECT | BASILIXIMAB | 20 MG | PDRE P PREP INJ | B/1F + S /5ML | NOVARTIS PHARMA | V | T | CS 16/05/2019 |
81 | ASPEGIC | ACETYL SALICYLATE DE LYSINE | 500 MG | PDRE PPREP INJ | B/20 FL | SANOFI AVENTIS | E | V | CS 16/05/2019 |
82 | ASPEGIC | ACETYL SALICYLATE DE LYSINE | 500 MG | PDRE PPREP INJ | B/6 FL | SANOFI AVENTIS | E | V | CS 16/05/2019 |
83 | OXYNORM | OXYCODONE (HCL) | 10 MG | SOL INJ | B/5 AMP/1ML | NAPP PHARMACEUTICALS LIMITED | V | N | CS 16/05/2019 |
84 | OXYNORM | OXYCODONE (HCL) | 20 MG | SOL INJ | B/5 AMP/2ML | NAPP PHARMACEUTICALS LIMITED | V | N | CS 16/05/2019 |
85 | OXYCONTIN | OXYCODONE (HCL) | 80 MG | COMPRIME LP | B/20 | PURDUE PHARMA L.P | E | N | CS 16/05/2019 |
86 | OXYCONTIN | OXYCODONE (HCL) | 10 MG | COMPRIME LP | B/20 | PURDUE PHARMA L.P | E | N | CS 16/05/2019 |
87 | OXYCONTIN | OXYCODONE (HCL) | 15 MG | COMPRIME LP | B/20 | PURDUE PHARMA L.P | E | N | CS 16/05/2019 |
88 | OXYCONTIN | OXYCODONE (HCL) | 20 MG | COMPRIME LP | B/20 | PURDUE PHARMA L.P | E | N | CS 16/05/2019 |
89 | OXYCONTIN | OXYCODONE (HCL) | 30 MG | COMPRIME LP | B/20 | PURDUE PHARMA L.P | E | N | CS 16/05/2019 |
90 | OXYCONTIN | OXYCODONE (HCL) | 40 MG | COMPRIME LP | B/20 | PURDUE PHARMA L.P | E | N | CS 16/05/2019 |
91 | OXYCONTIN | OXYCODONE (HCL) | 60 MG | COMPRIME LP | B/20 | PURDUE PHARMA L.P | E | N | CS 16/05/2019 |
92 | BUTRANS | BUPRENORPHINE | 5µG/H | PATCHS TRANSDERMIQUE | B/4 PATCHS | NAPP PHARMACEUTICALS LIMITED | V | N | CS 16/05/2019 |
93 | BUTRANS | BUPRENORPHINE | 10µG/H | PATCHS TRANSDERMIQUE | B/4 PATCHS | NAPP PHARMACEUTICALS LIMITED | V | N | CS 16/05/2019 |
94 | BUTRANS | BUPRENORPHINE | 20µG/H | PATCHS TRANSDERMIQUE | B/4 PATCHS | NAPP PHARMACEUTICALS LIMITED | V | N | CS 16/05/2019 |
95 | GRANOCYTE | LENOGRASTIM | 34MUI/ML | POUDRE ET SOLVANT POUR SOLUTION INJECTABLE | B/05 | SANOFI | V | N | 19/06/2019 |
96 | CANCIDAS | CASPOFUNGINE | 50 MG | PDRE P PREP INJ | B/01 | MERCK SHARP &DOHME BV | E | N | 21/06/2019 |
97 | CANCIDAS | CASPOFUNGINE | 70 MG | PDRE P PREP INJ | B/01 | MERCK SHARP &DOHME BV | E | N | 21/06/2019 |
98 | VFEND | VORICONAZOLE | 200MG | PDRE PR SOL PERFUSION | B/1 | PFIZER EUROPE | E | N | TRANSFERT 27/06/2019 |
99 | XALAtAN | LATANOPROST | 50µG/ML | COLLYRE | B/3FL2,5ML | PFIZER HOLDING | E | V | CS 09/07/2019 |
100 | XALAtAN | LATANOPROST | 50µG/MG | COLLYRE | B/1/FL2,5ML | PFIZER HOLDING | E | V | CS 09/07/2019 |
101 | XALAtAN | LATANOPROST+ TIMOLOL | 50µG/5MG | COLLYRE | FL/1FL | PFIZER HOLDING | E | V | CS 09/07/2019 |
102 | XALAtAN | LATANOPROST+ TIMOLOL | 50µG/5ML | COLLYRE | B/3F | PFIZER HOLDING | E | V | CS 09/07/2019 |
Spécialités Pharmaceutiques fabriquées localement :
* Produits déjà évalués lors des derniers Comités Techniques
N° | Médicament | DCI | Dosage | Forme Pharmaceutique | Présentation | Titulaire | VEIC | Type de demande | Date BA/ Courrier |
1 | ACARLYSE | ACARBOSE | 50mg | cp | B/90 | SAIPH | E | N | 07/06/2019 |
2 | ACARLYSE | ACARBOSE | 100mg | cp | B/90 | SAIPH | E | N | 07/06/2019 |
3 | DIARESTOP FLASH | LOPERAMIDE | 2 MG | COMP | B/10 | ADVANS PHARMA | I | N | 03/07/2019 |
4 | LOWRAC PLUS | VALSARTAN AMLODIPINE | 5MG/80MG | CP PELC | B/30 | SAIPH | E | N | 03/07/2019 |
5 | LOWRAC PLUS | VALSARTAN AMLODIPINE | 5MG/160MG | CP PELC | B/30 | SAIPH | E | N | 03/07/2019 |
6 | LOWRAC PLUS | VALSARTAN AMLODIPINE | 10MG/160MG | CP PELC | B/30 | SAIPH | E | N | 03/07/2019 |
* Produits à évaluer pour la première fois au Comité Technique
N° | Médicament | DCI | Dosage | Forme Pharmaceutique | Présentation | Titulaire | VEIC | Type de demande |
1 | CHLORPEOMAZINE | CHLORPROMAZINE | 25 mg | cp | B/30 | SIPHAT | E | N |
2 | CHLORPEOMAZINE | CHLORPROMAZINE | 100 mg | cp | B/30 | SIPHAT | E | N |