Dossiers d'AMM à étudier par le Comité Technique des Spécialités Pharmaceutiques du 05/03/2024.
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 du courrier |
1 | NASONEX | MOMETASONE | 50 MCG/DOSE | Susp NASAL | FL/140 DOSES | ORGANON TECHNIKA FRANCE | E | T | 01/04/2024 |
2 | KESIMPTA | OFATUMUMAB | 20 mg/0.4ml | SOL INJ | B/1STYLO | NOVARTIS PHARMA SCHWEIZ AG | N | 17/01/2024 | |
3 | ATOSIBAN EVER Pharma | ATOSIBAN | 37.5 mg/ 5 ml | SOL INJ PR PRF | B/1 flacon / 5ml | EVER Valinject GmbH | E | N | 02/06/2024 |
4 | ATOSIBAN EVER Pharma | ATOSIBAN | 75 mg/ 10 ml | SOL INJ PR PRF | B/1 flacon / 10ml | EVER Valinject GmbH | E | N | 02/06/2024 |
5 | ATOSIBAN EVER Pharma | ATOSIBAN | 6,75 mg/ 0,9 ml | SOL INJ PR PRF | B/1 flacon / 2 ml | EVER Valinject GmbH | E | N | 02/06/2024 |
6 | ENSPRYNG | SATRALIZUMAB | 120 mg/1 ml | SOL INJ | B/1 seringue | Roche Pharma (Schweiz) AG | N | 02/07/2024 | |
7 | ERIVEDGE | VISMODEGIB | 150 mg | GEL | B/28 | Roche Pharma (Schweiz) AG | N | 02/07/2024 | |
8 | CRESEMBA | ISAVUCONAZOLE | 100 MG | GEL | B/14 | HIKMA Pharmaceuticals | N | 19/02/2024 |
* 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 | AERIUS | DESLORATADINE | 5 MG | Cp Pell | B/15 | ||||
2 | ZINNAT | CEFUROXIME | 500 mg | Cp Pell | B/10 | SANDOZ PHARMACEUTICALS DD SLOVENIE | |||
3 | OLMESATAN MEDOXOMIL & AMLODIPINE /GENEPHARM | AMLODIPINE+OLMESARTAN MEDOXOMIL | 40 mg/5mg | COMP PEL | B/30 | GENEPHARM S.A | E | N | 12/12/2023 |
4 | OLMESATAN MEDOXOMIL & AMLODIPINE /GENEPHARM | AMLODIPINE+ OLMESARTAN MEDOXOMIL | 20 mg/5mg | COMP PEL | B/30 | GENEPHARM S.A | E | N | 12/12/2023 |
5 | OLMESATAN MEDOXOMIL & AMLODIPINE /GENEPHARM | AMLODIPINE+ OLMESARTAN MEDOXOMIL | 40 mg/10mg | COMP PEL | B/30 | GENEPHARM S.A | E | N | 12/12/2023 |
6 | CARDENSIEL | BISOPROLOL | 1.25 mg | COMP PEL | B/30 | Merck Santé s.a.s | E | N | 12/12/2023 |
7 | DIBASE | CHOLÉCALCIFÉROL | 50 000 UI /2.5ML | SOL BUV | B/ 1FL | ABIOGEN PHARMA S.p.A | E | N | 13/12/2023 |
8 | DIBASE | CHOLÉCALCIFÉROL | 100 000 UI /ML | SOL INJ | B/6 ampoules de 1ml | ABIOGEN PHARMA S.p.A | E | N | 13/12/2023 |
9 | DIBASE | CHOLÉCALCIFÉROL | 25 000 UI /2.5ML | SOL BUV | B/ 1FL monodose de 2.5 ml | ABIOGEN PHARMA S.p.A | E | N | 13/12/2023 |
10 | DIVINUSMET XR | DAPAGLIFLOZINE PROPANEDIOL / METFORMINE CHLORHYDRATE | 10 mg/1000 mg | COMP PEL | B/30 | HIKMA Pharmaceuticals | N | 13/12/2023 | |
11 | DIVINUSMET XR | DAPAGLIFLOZINE PROPANEDIOL / METFORMINE CHLORHYDRATE | 5 mg/1000 mg | COMP PEL | B/60 | HIKMA Pharmaceuticals | N | 13/12/2023 | |
12 | TOUJEO SOLOSTAR | INSULINE GLARGINE | 300 UI/ML | SOL INJ | B/3 STYLOS | SANOFI AVENTIS DEUTSCHLAND GmbH | V | V | CS 13/12/2023 |
13 | JANUMET | SITAGLIPTINE+METFORMINE | 50 mg/850mg | COMP PEL | B/56 | MERCK SHARP & DOHME BV | E | T | 13/12/2023 |
14 | SULIQUA | INSULINE GLARGINE + LIXISENATIDE | 100 Unités/ml + 50 µg/ml | SOL INJ | B/3 Stylos | SANOFI-AVENTIS FRANCE | V | N | 13/12/2023 |
15 | SULIQUA | INSULINE GLARGINE + LIXISENATIDE | 100 Unités /ml + 33 µg/ml | SOL INJ | B/3 Stylos | SANOFI-AVENTIS FRANCE | V | N | 13/12/2023 |
16 | BAXDELA | DELAFLOXACINE MEGLUMINE | 450 mg | COMP | B/20 | HIKMA Pharmaceuticals | N | CS 14/12/2023 | |
17 | BAXDELA | DELAFLOXACINE MEGLUMINE | 300 mg | PDRE PR PREP INJ | B/10FL/20ML | HIKMA Pharmaceuticals | N | CS 14/12/2023 | |
18 | MONURIL ADULTE | FOSFOMYCINE | 3 G | GRANULE PR SUSP BUV | B/1SACHET | ZAMBON FRANCE | E | V | CS 14/12/2023 |
19 | HEXAXIM | VACCIN D+T+C+P+HB+HIB | SUSP INJ | B/1 SER | SANOFI PASTEUR SA | E | V | CS 11/01/2024 | |
20 | CURACNE | ISOTRETINOINE | 40 MG | CAPSULE MOLLE | B/30 | PIERRE FABRE MEDICAMENT . | I | T | 24/01/2024 |
21 | TRANXENE | 10 MG | GELULE | B/30 | NEURAXPHARM FRANCE | I | T | 29/01/2024 | |
22 | AVASTIN | BEVACIZUMAB | 100 MG | SOL INJ PR PF | B/1FL | ROCHE PHARMA AG | E | V | CS 29/01/2024 |
23 | AVASTIN | BEVACIZUMAB | 400 MG | SOL INJ PR PF | B/1FL | ROCHE PHARMA AG | E | V | CS 29/01/2024 |
24 | CASODEX | BICALUTAMIDE | 50 MG | COMP ENROBE | B/30 | JUVISE PHARMACEUTICALS | V | T | CS 29/01/2024 |
25 | EMEND | APREPITANT | 80mg/125mg | GELULE | B/3 | MERCK SHARP & DOHME BV | C | T | CS 29/01/2024 |
26 | ZAVICEFTA | CEFTOZIDIME+ AVIBACTAM | 2G/0,5G | PDRE PR SOL PERF | B/10F | PFIZER IRELAND PHARMA | V | CS 30/01/2024 | |
27 | ZERBAXA | CEFTOLOZZANE+ TAZOBACTAM | 1G/0,5G | PDRE PR SOL PERF | B/10F | MERCK SHARP & DOHME UK | E | V | CS 30/01/2024 |
28 | BOOSTERIX | VACCIN DIPHTERQUE TETANIQUE COQUELUCHRUX | SUSP INJ | B/1seringues préremplies | GLAXOSMITHKLINE BIOLOGICALS BELGIUM | E | V | CS 30/01/2024 | |
29 | INFANRIX HEXA | VACCIN D+T+C+P+HB+HIB | SUSP INJ | B/1FL | GLAXOSMITHKLINE BIOLOGICALS BELGIUM | E | V | CS 30/01/2024 | |
30 | RINVOQ | UPADACITINIB | 15 MG | COMP LP | B/28 | ABBVIE DEUTSCHLAND Gmbh and Co.KG | N | CS 31/01/2024 | |
31 | XELJANZ XR | TOFACITINIB | 11 mg | COMP LP | B/30 | Pfizer Inc USA | E | N | CS 31/01/2024 |
32 | XELJANZ | TOFACITINIB | 5 mg | COMP LP | B/60 | PF PRISM/PFIZER NETHERLANDS | E | V | CS 31/01/2024 |
33 | SKYRIZI | RISANKIZUMAB | 150 mg | SOL INJ | B/1 seringue pré-remplie | ABBVIE DEUTSCHLAND Gmbh and Co.KG | E | N | CS 31/01/2024 |
34 | SKYRIZI | RISANKIZUMAB | 150 mg | SOL INJ | B/1 stylo pré-rempli | ABBVIE DEUTSCHLAND Gmbh and Co.KG | E | N | CS 31/01/2024 |
35 | TREMFYA | GUSELKUMAB | 100mg | SOL INJ | B/1 seringue pré-remplie | Janssen-Cilag International N.V | E | N | 31/01/2024 |
36 | TREMFYA | GUSELKUMAB | 100mg | SOL INJ | B/1 stylo pré-rempli | Janssen-Cilag International N.V | E | N | 31/01/2024 |
37 | Immunoglubuline humaine à injection intraveineuse (pH4) | IMMUNOGLOBULINE HUMAINE NORMALE | 5g (5%,100 ml) | SOL INJ PR PF | B/1AMP /100 ml | Sichuan Yuanda Shuyang Pharmaceutical Co.,Ltd | N | CS 07/02/2024 | |
38 | Immunoglubuline humaine à injection intraveineuse (pH4) | IMMUNOGLOBULINE HUMAINE NORMALE | 2.5 g (5%,50 ml) | SOL INJ PR PF | B/1AMP /50ML | Sichuan Yuanda Shuyang Pharmaceutical Co.,Ltd | N | CS 07/02/2024 | |
39 | IG VENA | IMMUNOGLOBULINE HUMAINE POLYVALENTE | 5G/100ML | SOL INJ PR PF | FL/100ML | KEDRION S.P.A | V | V | CS 07/02/2024 |
40 | IG VENA | IMMUNOGLOBULINE HUMAINE POLYVALENTE | 2,5G/50ML | SOL INJ PR PF | FL/50ML | KEDRION S.P.A | V | V | CS 07/02/2024 |
41 | PRIVIGEN | IMMUNOGLOBULINE HUMAINE POLYVALENTE | 10%(2,5g) | SOL INJ PR PF | FL/25ML | CSL BEHRING AG | I | V | CS 07/02/2024 |
42 | PRIVIGEN | IMMUNOGLOBULINE HUMAINE POLYVALENTE | 10% (10 g) | SOL INJ PR PF | FL/100ML | CSL BEHRING AG | I | V | CS 07/02/2024 |
43 | PRIVIGEN | IMMUNOGLOBULINE HUMAINE POLYVALENTE | 10% (5g) | SOL INJ PR PF | FL/100ML | CSL BEHRING AG | I | V | CS 07/02/2024 |
44 | HAEMOCOMPLETTAN P | FIBRINOGENE | 1 G | PDRE PR SUSP INJ | B/01FL | CSL BEHRING GMBH | V | V | CS 07/02/2024 |
45 | DARZALEX | daratumumab | 400mg/20 ML | SOL INJ | B/1FL/20ML | Janssen-Cilag International N.V | V | CS 07/02/2024 | |
46 | DARZALEX | daratumumab | 400mg/20 ML | SOL INJ | B/1FL/5ML | Janssen-Cilag International N.V | V | CS 07/02/2024 | |
47 | DARZALEX | daratumumab | 1800 mg | SOL INJ | B/1FL/5ML | Janssen-Cilag International N.V | N | CS 07/02/2024 | |
48 | BRUKINSA | ZANUBRUTINIB | 80 mg | GELULE | FL/120 | BeiGene USA,Inc | N | CS 07/02/2024 | |
49 | CURACNE | ISOTRETINOINE | 20 MG | CAPSULE MOLLE | B/30 | PIERRE FABRE MEDICAMENT | I | T | 16/02/2024 |
50 | CURACNE | ISOTRETINOINE | 5 MG | CAPSULE MOLLE | B/30 | PIERRE FABRE MEDICAMENT | I | T | 16/02/2024 |
51 | PHENYLEPHRINE | PHENYLEPHRINE | 50 microgrammes/ml | SOL INJ | B/10 | LABORATOIRE AGUETTANT | N | 16/02/2024 | |
52 | VIACORIND | PERINDOPRIL ARGININE+ INDAPAMIDE+ AMLODIPINE | 7 mg/2.5mg/5 mg | COMP | B/30 | SERVIER | E | N | 16/02/2024 |
53 | POLIVY | POLATUZUMAB VEDOTINE | 140 mg | SOL PR PF | FL/20 ml | HOFFMAN-LA-ROCHE INC. | V | N | 21/02/2024 |
54 | EPITAM | LEVETIRACETAM | 500 mg | SOL INJ PR PF | B/1 FL/5ML | HIKMA Pharmaceuticals | E | N | 21/02/2024 |
55 | NOZINAN | LEVOMEPROMAZINE | 4% | SOL BUV | FL/30ML | NEURAXPHARM FRANCE | T | 27/02/2024 | |
56 | SURMONTIL | TRIMIPRAMINE | 4% | SOL BUV | FL/30ML | NEURAXPHARM FRANCE | T | 27/02/2024 | |
57 | NOVOSEVEN | Facteur VII A | 1 MG | PDRE PR PREP INJ | B/1FL | NOVO NORDISK A/S BAGSFAERD | V | V | CS 29/02/2024 |
58 | NOVOSEVEN | Facteur VII A | 2 MG | PDRE PR PREP INJ | B/1FL | NOVO NORDISK A/S BAGSFAERD | V | V | CS 29/02/2024 |
59 | NOVOSEVEN | Facteur VII A | 5 MG | PDRE PR PREP INJ | B/1FL | NOVO NORDISK A/S BAGSFAERD | V | V | CS 29/02/2024 |
60 | TAMIFEN | TAMOXIFENE | 10 MG | COMP SECABLE | B/30 | MEDOCHEMIE LTD | V | V | CS 29/02/2024 |
61 | RHOPHYLAC | IMMUNOGLOBULINE HUMAINE ANTI D | 300µg/2ml | Sol inj | B/1 | CSL BEHRING AG | V | V | CS 29/02/2024 |
62 | PHARMATEX | CHLORURE DE BENZALKONIUM | 18,9 MG | CAPSULE MOLLE VAGI | B/6 | INNOTECH INTERATIONAL | I | V | CS 29/02/2024 |
63 | PHARMATEX | CHLORURE DE BENZALKONIUM | 18,9 MG | CAPSULE MOLLE VAGI | B/20 | INNOTECH INTERATIONAL | I | V | CS 29/02/2024 |
64 | BLISSEL | ESTRIOL | 50 µg/g | GEL VAGINAL | T/20G | ITALFARMACO ESPAGNE | I | V | CS 29/02/2024 |
65 | SLINDA | DROSPIRENONE | 4 mg | COMP PEL | B/ 24+4 | EXELTIS HEALTHCARE,S.L | E | N | CS 29/02/2024 |