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Dossiers d'AMM à étudier par le Comité Technique des Spécialités Pharmaceutiques du 11/12/2019.

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

Spécialités Pharmaceutiques importées :

  * Produits à évaluer pour la première fois au Comité Technique

Médicament DCI Dosage Forme Pharmaceutique Présentation TITULAIRE VEIC Type de la demande DATE RE
1 CERTICAN EVEROLIMUS 0,5 MG COMPRIME b/60 NOVARTIS PHARMA V N 13/05/2019
2 SIMULECT  BASILIXIMAB 20 MG PDRE P PREP INJ B/1F + S /5ML NOVARTIS PHARMA V T CS 16/05/2019
3 ASPEGIC ACETYL SALICYLATE DE LYSINE 500 MG PDRE PPREP INJ B/20 FL SANOFI AVENTIS  E V CS 16/05/2019
4 ASPEGIC ACETYL SALICYLATE DE LYSINE 500 MG PDRE PPREP INJ B/6 FL SANOFI AVENTIS  E V CS 16/05/2019
5 OXYNORM OXYCODONE  (HCL)  10 MG SOL INJ B/5 AMP/1ML NAPP PHARMACEUTICALS LIMITED V N CS 16/05/2020
6 OXYNORM OXYCODONE  (HCL)  20 MG SOL INJ B/5 AMP/2ML NAPP PHARMACEUTICALS LIMITED V N CS 16/05/2021
7 OXYCONTIN OXYCODONE  (HCL)  80 MG COMPRIME LP B/20 PURDUE PHARMA L.P E N CS 16/05/2022
8 OXYCONTIN OXYCODONE  (HCL)  10 MG COMPRIME LP B/20 PURDUE PHARMA L.P E N CS 16/05/2023
9 OXYCONTIN OXYCODONE  (HCL)  15 MG COMPRIME LP B/20 PURDUE PHARMA L.P E N CS 16/05/2024
10 OXYCONTIN OXYCODONE  (HCL)  20 MG COMPRIME LP B/20 PURDUE PHARMA L.P E N CS 16/05/2025
11 OXYCONTIN OXYCODONE  (HCL)  30 MG COMPRIME LP B/20 PURDUE PHARMA L.P E N CS 16/05/2026
12 OXYCONTIN OXYCODONE  (HCL)  40 MG COMPRIME LP B/20 PURDUE PHARMA L.P E N CS 16/05/2027
13 OXYCONTIN OXYCODONE  (HCL)  60 MG COMPRIME LP B/20 PURDUE PHARMA L.P E N CS 16/05/2028
14 BUTRANS  BUPRENORPHINE  5µG/H PATCHS TRANSDERMIQUE B/4 PATCHS NAPP PHARMACEUTICALS LIMITED V N CS 16/05/2029
15 BUTRANS  BUPRENORPHINE  10µG/H PATCHS TRANSDERMIQUE B/4 PATCHS NAPP PHARMACEUTICALS LIMITED V N CS 16/05/2030
16 BUTRANS  BUPRENORPHINE  20µG/H PATCHS TRANSDERMIQUE B/4 PATCHS NAPP PHARMACEUTICALS LIMITED V N CS 16/05/2031
17 LEUPRO SANDOZ LEUPRORELINE 3,6MG SERINGUE PRE REMPL B/01 SANDOZ PHARMA V N 09/06/2019
18 LEUPRO SANDOZ LEUPRORELINE 5 MG SERINGUE PRE REMPL B/01 SANDOZ PHARMA V N 09/06/2019
19 GRANOCYTE  LENOGRASTIM 34MUI/ML POUDRE ET SOLVANT POUR SOLUTION INJECTABLE B/05 SANOFI  V N 19/06/2019
20 AERIUS     DESLORATADINE  5 MG                           COMP PELLICULE B/15 Merck Sharp & Dohme Ltd R.U                                                         E N 20/06/2019
21 CANCIDAS CASPOFUNGINE 50 MG PDRE P PREP INJ B/01 MERCK SHARP &DOHME BV E N 21/06/2019
22 CANCIDAS CASPOFUNGINE 70 MG PDRE P PREP INJ B/01 MERCK SHARP &DOHME BV E N 21/06/2019
23 VFEND VORICONAZOLE 200MG PDRE PR SOL PERFUSION B/1 PFIZER EUROPE E N TRANSFERT 27/06/2019
24 XALAtAN LATANOPROST 50µG/ML COLLYRE B/3FL2,5ML PFIZER HOLDING  E V CS 09/07/2019
25 XALAtAN LATANOPROST 50µG/MG COLLYRE B/1/FL2,5ML PFIZER HOLDING  E V CS 09/07/2019
26 XALACOM LATANOPROST+ TIMOLOL 50µG/5MG COLLYRE FL/1FL PFIZER HOLDING  E V CS 09/07/2019
27 XALACOM LATANOPROST+ TIMOLOL 50µG/5ML COLLYRE B/3F PFIZER HOLDING  E V CS 09/07/2019
28 TOBRADEX DEXAMETHASONE +TOBRAMYCINE 100 MG/300MG COLLYRE B/1F NOVARTIS E N CS 09/07/2019
29 DAISYNELLE  DESOGESTREL+ ETHINYLOESTRADIOL 150/20µG COMPRIME B/21 STRAGEN E N 18/07/2019
30 ARNICA COMPLEXE N01 ARNICA   SOL BUVABLE EN GOUTTES FL/30ML LEHNING  C N 18/07/2019
31 ADOL PARACETAMOL 100MG/ML GOUTTES BUVABLES FL/15ML JULPHAR E V 18/07/2019
32 STOCRIN EFAVIRENZ                   600 mg cp pell FL/630 SOL BUV B/1FL/180 ml MERCK SHARP &DOHME BV E N TRANSFERT 22/07/2019
33 Cyclogest Progesterone 200 mg Suppositoires B/15 ld Collins UK   N/T 22/07/20219
34 OCREVUS                OCRELIZUMAB       300 MG SOL INJ PERF B/1FL/10ML ROCHE PHARMA (SCHWEIZ) LTD SUISSE                         V N 29/07/2019
35 GENSULIN R   INSULINE HUMAINE  100UI/ML         SOL INJ B/5Cartouches/3ML BIOTON S.A            V N 29/07/2019
36 GENSULIN M30 (30/70)               INSULINE HUMAINE    100UI/ML         SUSP INJ B/5Cartouches/3ML BIOTON S.A            V N 29/07/2019
37 GENSULIN N      INSULINE HUMAINE    100UI/ML         SUSP INJ B/5Cartouches/3ML BIOTON S.A            V N 29/07/2019
38 BENMAK            CHLORHYDRATE DE BENDAMUSTINE      25 MG (2.5mg/ml)      pdre pr sol perf B/5FL/10ML MAKPHARM D.O.O           E N 30/07/2019
39 BENMAK            CHLORHYDRATE DE BENDAMUSTINE      100 MG (2.5mg/ml)      pdre pr sol perf B/5FL/40ML MAKPHARM D.O.O           E N 30/07/2019
40 SEVOFLURANE USP             SEVOFLURANE          liquide pr inhalation B/1FL/250ML PIRAMAL CRITICAL CARE INC         V N 30/07/2019
41 AERIUS     DESLORATADINE  5 MG                           SIROP B/1 Merck Sharp & Dohme Ltd R.U                                                         E N 16/08/2019
42 REVLIMID            LENALIDOMIDE                   15 MG GELULE B/21 Celgene Europe B.V.        E N TRANSFERT 20/08/2019
43 REVLIMID            LENALIDOMIDE                   10 MG GELULE B/21 Celgene Europe B.V.        E N TRANSFERT 20/08/2019
44 REVLIMID            LENALIDOMIDE                   25 MG GELULE B/21 Celgene Europe B.V.        E N TRANSFERT 20/08/2019
45 REVLIMID            LENALIDOMIDE                   5 MG GELULE B/21 Celgene Europe B.V.        E N TRANSFERT 20/08/2019
46 ZINFORO CEFTAROLINE FOSAMIL    600 MG       PDRE PR SOL PERFUSION B/10F PFIZER Ireland Pharmaceuticals        E N TRANSFERT 27/08/2019
47 GONAL F PEN FOLLITROPINE  900 UI/1.5 ml         SOL INJ B/1stylo pré-rempli/1.5 ml +20 auig MERCK EUROPE B.V              E N 29/08/2019 TRANSFERT AVEC VARIATION
48 GONAL F PEN FOLLITROPINE  450 UI/0,75 ml         SOL INJ B/1stylo pré-rempli/1.5 ml +12 auig MERCK EUROPE B.V              E N 29/08/2019 TRANSFERT AVEC VARIATION
49 GONAL F PEN FOLLITROPINE  300 UI/0,5 ml         SOL INJ B/1stylo pré-rempli/1.5 ml +8 auig MERCK EUROPE B.V              E N 29/08/2019 TRANSFERT AVEC VARIATION
50 CEBESINE          OXYBUPROCAINE        0.4%         COLLYRE FL/5ML  CHAUVIN      I N 03/09/2019 Extention de présentation avec changement d cond I
51 VFEND VORICONAZOLE 40 MG/ML PDRE PR SUSP ORALE B/1FL DE45G PFIZER EUROPE MA EEIG  E N TRANSFERT 05/09/2019
52 RAPAMUNE      SIROLIMUS         1 MG COMP ENROBE B/30 PFIZER S.A BELGIQUE       E N TRANSFERT 16/09/2019
53 VFEND VORICONAZOLE 200MG COMP PELLICULE B/14 PFIZER EUROPE MA EEIG  E N TRANSFERT 19/09/2019
54 VFEND VORICONAZOLE 50 MG COMP PELLICULE B/28 PFIZER EUROPE MA EEIG  E N TRANSFERT 19/09/2019
55 DIAMOX 250 MG           ACETAZOLAMIDE           250 mg   COMP B/24 COOPERATION PHARMACEUTIQUE FRANCAISE E N TRANSFERT 09/10/2019
56 SUTENT       SUNITINIB         12.5 mg           GELULE B/28 PFIZER  Europe MA EEIG       E N Transfert 29/10/2019
57 SUTENT       SUNITINIB         25 mg           GELULE B/28 PFIZER  Europe MA EEIG       E N Transfert 29/10/2019
58 SUTENT       SUNITINIB         50 mg           GELULE B/28 PFIZER  Europe MA EEIG       E N Transfert 29/10/2019
59 DYNASTAT       PARECOXIB   40MG PDRE PR SOL INJ B/10F PFIZER  Europe MA EEIG       E N TRANSFERET 29/10/2019
60 TEMOZOLOMIDE ACCORD      TÉMOZOLOMIDE      5 mg           GELULE B/5 ACCORD HEALTHCARE LTD       E N 01/11/2019
61 TEMOZOLOMIDE ACCORD      TÉMOZOLOMIDE      250 mg           GELULE B/5 ACCORD HEALTHCARE LTD       E N 01/11/2019
62 TEMOZOLOMIDE ACCORD      TÉMOZOLOMIDE      20 mg           GELULE B/5 ACCORD HEALTHCARE LTD       E N 01/11/2019
63 TEMOZOLOMIDE ACCORD      TÉMOZOLOMIDE      100 mg           GELULE B/5 ACCORD HEALTHCARE LTD       E N 01/11/2019
64 SOOLANTRA        IVERMECTINE   10mg/gr        CREME DERMIQUE  B/1tube de 15gr GALDERMA INTERNATIONAL           C N 11/11/2019
65 SERESTA           OXAZEPAM   50 MG    COMP B/20 BIODIM    I N 11/11/2019
66 SERESTA           OXAZEPAM   10 MG    COMP B/30 BIODIM    I N 11/11/2019
67 ELIQUIS          APIXABAN       2.5 mg       COMP PELLICULE B/20 Bristol-Myers Squibb/Pfizr EEIG    E N TRANSFERT 12/11/2019
68 ELIQUIS          APIXABAN       2.5 mg       COMP PELLICULE B/60 Bristol-Myers Squibb/Pfizr EEIG    E N TRANSFERT 12/11/2019
69 ELIQUIS          APIXABAN       5 mg       COMP PELLICULE B/60 Bristol-Myers Squibb/Pfizr EEIG    E N 12/11/2019
70 ELIQUIS          APIXABAN       5 mg       COMP PELLICULE B/20 Bristol-Myers Squibb/Pfizr EEIG    E N 12/11/2019
71 TOBRADEX               DEXAMETHASONE+TOBRAMYCINE             Tube/3.5 gr pommade ophtalmo Tube NOVARTIS PHARMA SCHWEIZ AG        E N Transfert avec variation 14/11/2019
72 REBIF        INTERFERON BETA-1A   12 MUI/0.5 ml      SERINGUE PRE REMPL B/12 seringues/0.5ML MERCK EUROPE B.V   E N TRANSFERT   15 /11/2019
73 ULTRA-LEVURE        SACCHAROMYCES BOULARDII                                                             200 mg       GELULE FL/30   BIOCODEX         I N 18/11/2019
74 BRINTELLIX           VORTIOXETINE 10 MG                                                                            COMP PELLICULE B/28 H.LUNDBECK A/S         E N CS 25/11/2019
75 ZELDOX ZIPRASIDONE 20 MG/ML PDRE PR PREP INJ B/1FL+S/1,2ML PFIZER GMbH E V CS 25/11/2019
76 ABILIFY ARIPIPRAZOLE 15 MG COMP B/28 ABDI IBRAHIM OTSUKA E V CS 25/11/2019
77 ABILIFY ARIPIPRAZOLE 10 MG COMP B/28 ABDI IBRAHIM OTSUKA E V CS 25/11/2019
78 UTROGESTAN PROGESTERONE 100 MG CAPSULE MOLLE B/30 BESINS INT  E V CS 26/11/2019
79 RHOPHYLAC IMMUNOGLOBUNE HUMAINE ANTI D 300µG/2ML SERINGUE PRE REMPL B/1 CSL BEHRINGER E V CS 26/11/2019
80 CRESTOR ROSUVASTATINE 5 MG COMP PELLICULE B/30 ASTRAZENECA E V CS 26/11/2019
81 CRESTOR ROSUVASTATINE 20 MG COMP PELLICULE B/30 ASTRAZENECA E V CS 26/11/2019
82 CRESTOR ROSUVASTATINE 10 MG COMP PELLICULE B/30 ASTRAZENECA E V CS 26/11/2019
83 TRESIBA  INSULINE DEGLUDEG 200 UI/ML SOL INJ B/3 NOVO NORDISK V V CS 26/11/2019
84 TRESIBA FLEXTOUCH INSULINE DEGLUDEG 100 UI/ML SOL INJ B/5 NOVO NORDISK V V CS 26/11/2019
85 XELJANZ TOFACITINIB 5 MG COMP PELLICULE B/60 PF PRISM C,V C/O PFIZER NETHERLANDS E V CS 26/11/2019
86 IMMUNORHO IMMUNOGLOBUNE HUMAINE ANTI D 300µG PDRE PR PREP INJ B/1FL KEDRION S.P.A E V CS 26/11/2019
87 COMBIVIR              LAMIVUDINE+ZIDOVUDINE     150mg/300mg           COMP PELLICULE SECABLE B/60 ViiV Healthcare BV                                                                  E N TRANSFERT 26/11/2019
88 EPIVIR     LAMIVUDINE     150 mg             COMP PELLICULE SECABLE FL/60 ViiV Healthcare BV                                                                  E N TRANSFERT 26/11/2019
89 RETROVIR   ZIDOVUDINE            100 mg          GELULE B/100 ViiV Healthcare BV        E N TRANSFERT 26/11/2019
90 TOBREX     TOBRAMYCINE    0.3%                                                                                COLLYRE FL/5ML NOVARTIS PHARMA  AG (Bâle Suisse)         E V TRANSFERT avec variation 27/11/2019
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