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  • Comité Technique des Spécialités Pharmaceutiques du 11 mars 2020

    Comité Technique des Spécialités Pharmaceutiques du 11 mars 2020

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Spécialités Pharmaceutiques importées :

  * Produits déjà évalués lors des derniers Comités Techniques  

N° Médicament DCI Dosage Forme Pharmaceutique Présentation TITULAIRE VEIC Type de demande date du courrier
1 STODALINE    SANS SUCRE       PRODUITS HOMEOPATHIQUES         SIROP FL/200 ML BOIRON         C N 19/09/2019
2 SUXAMETHONIUM CHLORID VUAB         SUXAMETHONIUM             100 mg     PDRE P SUSP INJ B/1FL VUAB PHARMA AS                                                                      V N 20/09/2019
3 GAZYVARO             OBINUTUZUMAB      1000MG/40ML           SOL INJ B/1FL/40ML ROCHE PHARMA (SCHWEIZ) LTD SUISSE      E N 25/09/2019
4 LOTEMAX  LOTEPREDNOL      0.5%       GEL OPHTALMIQUE FL /10ml BAUSCH AND LOMB        E N 29/09/2019
5 RELVAR ELLIPTA  FUROATE DE FLUTICASONE/VILANTEROL 92/22µg PDRE PR INHALATION BUCCALE B/1 INH DE 30 DOSES GALAXO GROUP LTD E V 30/09/2019
6 RELVAR ELLIPTA  FUROATE DE FLUTICASONE/VILANTEROL 184/22µg PDRE PR INHALATION BUCCALE B/1 INH DE 30 DOSES GALAXO GROUP LTD E V 30/09/2019
7 STELARA    USTEKINUMAB 45 mg/0.5ml          SOL INJ B/1FL/0.5ml Janssen-Cilag International N.V            E N 01/10/2019
8 STELARA    USTEKINUMAB 45 mg/0.5ml          SOL INJ B/1seringue pré-remplie/0.5ml Janssen-Cilag International N.V            E N 01/10/2019
9 STELARA    USTEKINUMAB 130mg/26ml     SOL INJ PR PERF B/1FL/30ML Janssen-Cilag International N.V        E N 01/10/2019
10 STELARA    USTEKINUMAB 90mg/ml              SOL INJ B/1Seringue pré-remplie/1ml Janssen-Cilag International N.V        E N 01/10/2019
11 PMS-RISEDRONATE             RISEDRONATE 35 mg             COMP PEL B/4 PHARMASCIENCE INC CANADA              E N 02/10/2019
12 PROLUTEX        PROGESTERONE 25mg        SOL INJ B/7Flacons IBSA Institut Biochimique SA    E N 02/10/2019
13 AKYNZEO        NETUPITANT+PALONOSETRON 300mg/ 0.5mg       GELLULE B/1 HELSINN BIREX Pharmaceuticals Ltd        E N  07/10/2019
14 TARGINACT  OXYCODONE+NALOXONE 40mg/20mg        COMP B/56 Napp Pharmaceuticals Limited           V N 08/10/2019
15 TARGINACT  OXYCODONE+NALOXONE 20mg/10mg        COMP B/56 Napp Pharmaceuticals Limited           V N 08/10/2019
16 TARGINACT  OXYCODONE+NALOXONE 10mg/5mg        COMP B/56 Napp Pharmaceuticals Limited           V N 08/10/2019
17 ALDARA     IMIQUIMOD 5% CREME DERMIQUE B/12 Sachets Unidoses/250 mg MEDA AB            E N 09/10/2019
18 RANEXA       RANOLAZINE 500 mg        COMP  B/60 Menarini International Operation Luxembourg S.A              E N 23/10/2019
19 RANEXA       RANOLAZINE 750 mg        COMP  B/60 Menarini International Operation Luxembourg S.A              E N 23/10/2019
20 MYDRANE     TROPICAMIDE+ CHLORHYDRATE DE PHENYLEPHRINE+ CHLORHYDRATE DE                         0.2mg/ml+         3.1mg/ml+ 10mg/ml        AMPOULE B/20 Ampoules de 1 ml + 20 aiguilles  THEA             I N 24/10/2019
21 HUMIRA       ADALIMUMAB 40 mg    SERINGUE B/2 seringues/0.4 ml ABBVIE DEUTSCHLAND Gmbh and Co.KG     E N 29/10/2019
22 LIPANTHYL          FENOFIBRATE          145 mg     COMP PEL B/30 MYLAN MEDICAL SAS             E N 29/10/2019
23 SIMPONI     GOLIMUMAB        100 mg         SOL INJ B/1 Stylo Pré-rempli/1ml JANSSEN BIOLOGICS B.V         V N 12/11/2019
24 INLYTA  AXITINIB  5 mg           COMP PEL B/28 PFIZER AG           V N 20/11/2019
25 INLYTA  AXITINIB  5 mg           COMP PEL B/56 PFIZER AG           V N 20/11/2019
26 INLYTA  AXITINIB  1 mg           COMP PEL B/56 PFIZER AG           V N 20/11/2019
27 INLYTA  AXITINIB  1 mg           COMP PEL B/28 PFIZER AG           V N 20/11/2019
28 TOT'HEMA     CUIVRE+MANGANESE+FER       0.7mg/1.33mg/50mg          SOL BUV B/20AMP/10ml INNOTECH INTERNATIONAL                                                              E N 26/11/2019
29 DEXAFREE      DEXAMETHASONE          1 mg/ml         COLLYRE MONODOSE B/30 unidoses/0.4 ml THEA          E N 28/11/2019
30 PRILIGY        DAPOXETINE   30 mg      COMP PEL B/3 MENARINI Ind.Farmaceutiche Riunite SRL     C N 18/12/2019
31 PRILIGY        DAPOXETINE   60 mg      COMP PEL B/3 MENARINI Ind.Farmaceutiche Riunite SRL     C N 18/12/2019
32 MIRVASO       BRIMONIDINE        3MG/GR                                                                              GEL DERMIQUE Tube/30gr GALDERMA INTERNATIONAL                 C N 27/12/2019
33 EYLEA            AFLIBERCEPT    40 mg/ml                SOL INJ FL/ 100 ml BAYER  AG Leverkusen      N 30/12/2019
34 ALLERGODIL         AZELASTINE        0.05%       COLLYRE FL/6ML  MEDA PHARMA   E N 21/01/2020
35 SUPRANE        DESFLURANE                                                                          100% LIQUIDE VOLATIL B/ 6 FL/240ML BAXTER HEALTHCARE  V N 24/02/2020
36 SEVOFLURANE USP     SEVOFLURANE  100% LIQUIDE VOLATIL B/ 6 FL/250ML BAXTER HEALTHCARE  V N 24/02/2020
37 SEVOFLURANE USP                 SEVOFLURANE                                                                         100% LIQUIDE PR INHA B/1FL /250ML PIRAMAL CRITICAL CARE INC    V N 24/02/2020

  * 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 REBIF INTERFERON BETA-1A         6 MUI     SOL INJ B/12 seringues MERCK EUROPE B.V          E N TRANSFERT 28/05/2019
2 DIAMOX 250 MG           ACETAZOLAMIDE           250 mg   COMP B/24 COOPERATION PHARMACEUTIQUE FRANCAISE E N TRANSFERT 09/10/2019
3 ZAVICEFTA      CEFTAZIDIME+ AVIBACTAM           2g/0.5g                                                                             PDRE PR SOL PERF B/10FL PFIZER Ireland Pharmaceuticals        N 22/10/2019
4 SUTENT       SUNITINIB         12.5 mg           GELULE B/28 PFIZER  Europe MA EEIG       E N Transfert 29/10/2019
5 SUTENT       SUNITINIB         25 mg           GELULE B/28 PFIZER  Europe MA EEIG       E N Transfert 29/10/2019
6 SUTENT       SUNITINIB         50 mg           GELULE B/28 PFIZER  Europe MA EEIG       E N Transfert 29/10/2019
7 DYNASTAT       PARECOXIB   40MG PDRE PR SOL INJ B/10F PFIZER  Europe MA EEIG       E N TRANSFERET 29/10/2019
8 SOOLANTRA        IVERMECTINE   10mg/gr        CREME DERMIQUE  B/1tube de 15gr GALDERMA INTERNATIONAL           C N 11/11/2019
9 SERESTA           OXAZEPAM   50 MG    COMP B/20 BIODIM    I N 11/11/2019
10 SERESTA           OXAZEPAM   10 MG    COMP B/30 BIODIM    I N 11/11/2019
11 MINESSE ETHINYLESTRADIOL+GESTODENE 60µg/15µg COMP PELLICULE B/28 PFIZER HOLDING  E V 14/11/2019 changement de la composition
12 TOBRADEX               DEXAMETHASONE+TOBRAMYCINE             Tube/3.5 gr pommade ophtalmo Tube NOVARTIS PHARMA SCHWEIZ AG        E N Transfert avec variation 14/11/2019
13 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
14 ULTRA-LEVURE        SACCHAROMYCES BOULARDII                                                             200 mg       GELULE FL/30   BIOCODEX         I N 18/11/2019
15 BRINTELLIX           VORTIOXETINE 10 MG                                                                            COMP PELLICULE B/28 H.LUNDBECK A/S         E N CS 25/11/2019
16 ZELDOX ZIPRASIDONE 20 MG/ML PDRE PR PREP INJ B/1FL+S/1,2ML PFIZER GMbH E V CS 25/11/2019
17 ABILIFY ARIPIPRAZOLE 15 MG COMP B/28 ABDI IBRAHIM OTSUKA E V CS 25/11/2019
18 ABILIFY ARIPIPRAZOLE 10 MG COMP B/28 ABDI IBRAHIM OTSUKA E V CS 25/11/2019
19 GILENYA FINGOLIMOD 0,5 MG GELULE B/28 NOVARTIS PHARMA   V CS 25/11/2019
20 UTROGESTAN PROGESTERONE 100 MG CAPSULE MOLLE B/30 BESINS INT  E V CS 26/11/2019
21 RHOPHYLAC IMMUNOGLOBUNE HUMAINE ANTI D 300µG/2ML SERINGUE PRE REMPL B/1 CSL BEHRINGER E V CS 26/11/2019
22 CRESTOR ROSUVASTATINE 5 MG COMP PELLICULE B/30 ASTRAZENECA E V CS 26/11/2019
23 CRESTOR ROSUVASTATINE 20 MG COMP PELLICULE B/30 ASTRAZENECA E V CS 26/11/2019
24 CRESTOR ROSUVASTATINE 10 MG COMP PELLICULE B/30 ASTRAZENECA E V CS 26/11/2019
25 TRESIBA  INSULINE DEGLUDEG 200 UI/ML SOL INJ B/3 NOVO NORDISK V V CS 26/11/2019
26 TRESIBA FLEXTOUCH INSULINE DEGLUDEG 100 UI/ML SOL INJ B/5 NOVO NORDISK V V CS 26/11/2019
27 XELJANZ TOFACITINIB 5 MG COMP PELLICULE B/60 PF PRISM C,V C/O PFIZER NETHERLANDS E V CS 26/11/2019
28 IMMUNORHO IMMUNOGLOBUNE HUMAINE ANTI D 300µG PDRE PR PREP INJ B/1FL KEDRION S.P.A E V CS 26/11/2019
29 COMBIVIR              LAMIVUDINE+ZIDOVUDINE     150mg/300mg           COMP PELLICULE SECABLE B/60 ViiV Healthcare BV                                                                  E N TRANSFERT 26/11/2019
30 EPIVIR     LAMIVUDINE     150 mg             COMP PELLICULE SECABLE FL/60 ViiV Healthcare BV                                                                  E N TRANSFERT 26/11/2019
31 RETROVIR   ZIDOVUDINE            100 mg          GELULE B/100 ViiV Healthcare BV        E N TRANSFERT 26/11/2019
32 TOBREX     TOBRAMYCINE    0.3%                                                                                COLLYRE FL/5ML NOVARTIS PHARMA  AG (Bâle Suisse)         E V TRANSFERT avec variation 27/11/2019
33 KISQALI       RIBOCICLIB SUCINATE                                                                 200 MG COMP PEL B/63 NOVARTIS PHARMA SCHWEIZ AG    V N 05/12/2019
34 RAPIFEN            ALFENTANIL  1 mg (0.5mg/ml)         SOL INJ B/5/2 ML   Piramal Critical Care Limited   V N TRANSFERT 06/12/2019
35 DARZALEX        Daratumumab         20mg/ml    SOL INJ B/1FL/5ML Janssen-Cilag International N.V         N CS 03/12/2019
36 DARZALEX        Daratumumab         20mg/ml    SOL INJ B/1FL/20ML Janssen-Cilag International N.V         N CS 03/12/2019
37 VENCLYXTO             VENETOCLAX                                                                          10 mg          COMP PELL B/14 ABBVIE DEUTSCHLAND Gmbh and Co.KG           N CS 03/12/2019
38 PURINETHOL MERCAPTOPURINE 50 MG COMP SECABLE FL/25 ASPEN PHARMA V V CS 03/12/2019
39 TASIGNA NILOTINIB 150 mg             GELULE B/112 NOVARTIS PHARMA  V V CS 03/12/2019
40 TASIGNA NILOTINIB 200 mg             GELULE B/28 NOVARTIS PHARMA  V V CS 03/12/2019
41 IMBRUVICA IBRUTINIB 140 MG GELULE B/90 Janssen-Cilag International N.V       E V CS 03/12/2019
42 VENCLYXTO           VENETOCLAX        100 mg          COMP PEL B/7 ABBVIE ltd       N CS 03/12/2019
43 VENCLYXTO           VENETOCLAX        50 mg          COMP PEL B/7 ABBVIE ltd       N CS 03/12/2019
44 VENCLYXTO           VENETOCLAX        10 mg          COMP PEL B/14 ABBVIE ltd       N CS 03/12/2019
45 VENCLYXTO           VENETOCLAX        100 mg          COMP PEL B/14 ABBVIE ltd       N CS 03/12/2019
46 VENCLYXTO           VENETOCLAX        100 mg          COMP PEL B/112 ABBVIE ltd       N CS 03/12/2019
47 ZIAGEN        ABACAVIR      300 mg    COMP PEL B/60 ViiV Healthcare BV       E N Transfert 04/12/2019
48 VIAGRA           SILDENAFIL       25 MG      COMP PEL B/4 PFIZER  Europe MA EEIG      c N TRANSFERT 09/12/2019
49 VIAGRA           SILDENAFIL       50 MG      COMP PEL B/4 PFIZER  Europe MA EEIG      c N TRANSFERT 16/12/2019
50 VIAGRA           SILDENAFIL       100 MG      COMP PEL B/4 PFIZER  Europe MA EEIG      c N TRANSFERT 16/12/2019
51 INVANZ      ERTAPENEM           1 GR        PDRE PR PREP INJ B/1F/15ML Merck Sharp & Dohme Ltd R.U           E N CS 20/12/2019
52 RIFOCINE RIFAMYCINE 250 MG SOL INJ B/1FL/3ML SANOFI AVENTIS SPA E V CS 20/12/2019
53 PREVENAR 13   VACCIN PNEUMOCOCCIQUE   NA SUSP INJ B/1seringue pré-remplie/0.5ml  PFIZER  Europe MA EEIG   I N TRANSFERT 20/12/2019
54 SOLICARE          SOLIFENACINE SUCCINATE            5 mg COMP PEL B/30 GENEPHARM S.A       E N 20/12/2019
55 SOLICARE          SOLIFENACINE SUCCINATE            10 mg COMP PEL B/30 GENEPHARM S.A       E N 20/12/2019
56 RILUZOLE MYLAN 50         RILUZOLE   50 mg      COMP PEL B/56 MYLAN S.A.S             E N 24/12/2019
57 DUPHASTON                   DYDROGESTERONE    10 MG    COMP B/10 Abbott B.V          E N TRANSFERT 25/12/2019
58 RHESONATIV  IMMUNOGLOBUNE HUMAINE ANTI D 625 UI/ML  SOL INJ B/1/2ML OCTAPHARMA  E V 25/12/2019
59 KETODERM 2% GEL EN SACHET           KETOCONAZOLE              2% GEL DERMIQUE B/8/6 GR   EG LABO - Laboratoires Eurogenerics SAS     E N TRANSFERT 31/12/2019
60 XOLAIR  OMALIZUMAB 150 mg             PDRE PR SOL INJ B/1F NOVARTIS PHARMA AG   V CS 06/01/2020
61 BRICANYL LP TERBUTALINE 5 MG COMP LP FL/60 ASTRA ZENECA E V CS 06/01/2020
62 ELIQUIS     APIXABAN   5 MG      COMP PEL B/20 Bristol-Myers Squibb/Pfizr EEIG     E N CS 06/01/2020
63 ELIQUIS     APIXABAN   5 MG      COMP PEL B/60 Bristol-Myers Squibb/Pfizr EEIG     E N CS 06/01/2020
64 ELIQUIS     APIXABAN   2,5MG      COMP PEL B/20 Bristol-Myers Squibb/Pfizr EEIG     E N TRANSFERT   CS 06/01/2020
65 ELIQUIS     APIXABAN   5 MG      COMP PEL B/20 Bristol-Myers Squibb/Pfizr EEIG     E N TRANSFERT   CS 06/01/2020
66 SUXAMETHONIUM-LABESFAL SUXAMETHONIUM 100 MG/2ML SOL INJ B/100/2ML LABESFAL V V CS 06/01/2020
67 DESLORATADINE GENEPHARM          DESLORATADINE         5 MG         COMP B/30 GENEPHARM S.A            E N 15/01/2020
68 DESLORATADINE GENEPHARM          DESLORATADINE         2,5 MG         COMP B/30 GENEPHARM S.A            E N 15/01/2020
69 LEVONORGESTREL MYLAN     LEVONORGESTREL       1.5 mg       COMP  B/1 MYLAN S.A.S  E N 15/01/2020
70 VAXIGRIP VACCIN ANTIGRIPPE   SUSP INJ B/1SER/0,5 ML SANOFI PASTEUR SA I V CS 17/01/2020
71 JADENU           DEFERASIROX     360MG                                                                               COMP PEL B/30 NOVARTIS PHARMA SCHWEIZ AG                      V N 22/01/2020
72 JADENU           DEFERASIROX     180MG                                                                               COMP PEL B/90 NOVARTIS PHARMA                 V N 22/01/2020
73 JADENU           DEFERASIROX     90MG                                                                               COMP PEL B/90 NOVARTIS PHARMA                 V N 22/01/2020
74 VESOMNI          SOLIFENACINE+ TAMSULOSINE   6mg/0.4mg    COMP B/30 ASTELLAS PHARMA EUROPE  B.V HOLLANDE        N 22/01/2020
75 TOMEC   DORZOLAMIDE+ TIMOLOL         100 mg/ 25mg       COLLYRE FL/5 ml ABDI IBRAHIM IIac San. ve Tic. A.S.                          E N 22/01/2020
76 OFNOL       OLOPATADINE   0.1%      COLLYRE FL/5 ml ABDI IBRAHIM IIac San. ve Tic. A.S.   E N 04/02/2020
77 ORAP        PIMOZIDE         4 MG         COMP B/30       EUMEDICA PHARMACEUTICALS GmbH     E N TRANSFERT   04/02/2020
78 ALECENSA          ALECTINIB          150  MG         GELULE B/224 ROCHE PHARMA (SCHWEIZ) LTD SUISSE            N 10/02/2020
79 REDDITUX     RITUXIMAB      500 mg/50ml    SOL INJ B/1FL DR REDDY'S LABORATORIES LTD         V N CS 13/02/2020
80 REDDITUX     RITUXIMAB      100 mg/10ml    SOL INJ B/1FL DR REDDY'S LABORATORIES LTD         V N CS 13/02/2020
81 NOCDURNA     DESMOPRESSINE            50 µg       LYOPHI ORAL B/30 FERRING ARZNEIMITTEL GmbH            E N 17/02/2020
82 NOCDURNA     DESMOPRESSINE            25 µg       LYOPHI ORAL B/30 FERRING ARZNEIMITTEL GmbH            E N 17/02/2020
83 TOBREX      TOBRAMYCINE    0.3%   pommade ophtalmo Tube/3.5 gr NOVARTIS PHARMA SCHWEIZ AG                                                          E N 17/02/2020
84 TOBRADEX              DEXAMETHASONE+ TOBRAMYCINE        100 mg/300 mg       COLLYRE FL/5 ml NOVARTIS PHARMA SCHWEIZ AG         E N CS 09/07/2019
85 DIPIPERON         PIPAMPERONE       40 MG      COMP B/20       EUMEDICA PHARMACEUTICALS GmbH    E N Transfert 19/02/2020
86 COSENTYX SECUKINUMAB          150MG/ML     SOL INJ B/2 seringues  pré_remplis NOVARTIS EUROPHARM LIMITED IRLANDE          E N Transfert 21/02/2020
87 COSENTYX SECUKINUMAB          150MG/ML     SOL INJ B/2 Stylos pré_remplis NOVARTIS EUROPHARM LIMITED IRLANDE          E N Transfert 21/02/2020
88 ENBREL           ETANERCEPT         50 mg               SOL INJ B/4 stylos pré-remplis PFIZER  Europe MA EEIG         E N Transfert 21/02/2020
89 ENBREL           ETANERCEPT         25 mg               SOL INJ B/4 seringues pré-remplis PFIZER  Europe MA EEIG         E N Transfert 21/02/2020

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