Dossiers d'AMM à étudier par le Comité Technique des Spécialités Pharmaceutiques du 23/12/2020.
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 | ZYTIGA | ABIRATERONE | 250 mg | CP PEL | B/120 | Janssen-Cilag International N.V | V | V | 12/05/2020 |
2 | HERCEPTIN SOUS-CUTANE | TRASTUZUMAB | 600mg | SOL INJ | FL/5ml | ROCHE PHARMA (SCHWEIZ) LTD SUISSE | V | N | 19/05/2020 |
3 | ACIDE ZOLEDRONIQUE MYLAN | ACIDE ZOLÉDRONIQUE | 4 MG/5 ML | SOL INJ | B/ 1FL/ 5ml | MYLAN S.A.S | E | N | 22/05/2020 |
4 | ZELBORAF | VEMURAFENIB | 240 mg | CP PEL | B/56 | ROCHE PHARMA (SCHWEIZ) LTD SUISSE | V | N | 28/05/2020 |
5 | FASLODEX | FLUVESTRANT | 250 mg | SOL INJ | B/2/5ML | ASTRA ZENECA | V | V | 02/06/2020 |
6 | TOUJEO | INSULINE GLARGINE | 300unités/ml | SOL INJ | B/3 Stylos | SANOFI-AVENTIS Deutschland GmbH | V | N | 02/06/2020 |
7 | CYCLOGEST | PROGESTERONE | 200 MG | SUPPO | B/15 | L.D.Collins & Co.ltd | E | N | 05/06/2020 |
8 | CERTICAN | EVEROLIMUS | 0,5 MG | COMPRIME | B/60 | NOVARTIS PHARMA | V | N | 18/06/2020 |
9 | SUXAMETHONIUM CHLORID VUAB | SUXAMETHONIUM | 100 mg | PDRE PR SUS INJ | B/1FL | VUAB PHARMA AS | V | N | 26/06/2020 |
10 | AERIUS | DESLORATADINE | 0.5 mg/ml | SOL BUV | FL/150 ml | MERCK SHARP & DOHME BV | E | N | 25/06/2020 |
11 | CLARISCAN | MEGLUMINE GODATERATE | 0.5mmol/ml | SOL INJ | B/10FL/10 ML | GE HEALTHCARE AS NORVEGE | E | N | 30/06/2020 |
12 | CLARISCAN | MEGLUMINE GODATERATE | 0.5mmol/ml | SOL INJ | B/10FL/15 ML | GE HEALTHCARE AS NORVEGE | E | N | 30/06/2020 |
13 | CLARISCAN | MEGLUMINE GODATERATE | 0.5mmol/ml | SOL INJ | B/10FL/20ML | GE HEALTHCARE AS NORVEGE | E | N | 30/06/2020 |
14 | DARZALEX | DARATUMUMAB | 20mg/ml | SOL INJ | B/1FL/20ML | Janssen-Cilag International N.V | N | 02/07/2020 | |
15 | DARZALEX | DARATUMUMAB | 20mg/ml | SOL INJ | B/1FL/5ML | Janssen-Cilag International N.V | N | 02/07/2020 | |
16 | PURINETHOL | MERCAPTOPURINE | 50 MG | CP SEC | FL/25 | ASPEN PHARMA | V | V | |
17 | BRINTELLIX | VORTIOXETINE | 10 mg | COMP PEL | B/28 | H.LUNDBECK A/S | E | N | 17/07/2020 |
18 | NATEMILLE | CALCIUM+VITAMINE D3 | 600MG/1000UI | Comprimé orodispersible | B/30 | ITALFARMACO S.p.A ITALIA | E | N | 30/07/2020 |
19 | LIBLAB | EXTRAIT SEC DE FEUILLE DE LIERRE | 35.7mg | Comprimés à sucer | B/20 | DAR ALDAWA | C | N | 07/08/2020 |
20 | DROPERIDOL AGUETTANT | DROPERIDOL | 1.25 mg/ml | SOL INJ | B/10 AMP | AGUETTANT | E | N | 05/09/2020 |
21 | COSENTYX | SECUKINUMAB | 150mg/ml | SOL INJ | B/2seringues | NOVARTIS PHARMA | E | N | 15/09/2020 |
22 | COSENTYX | SECUKINUMAB | 150mg/ml | SOL INJ | B/2stylos | NOVARTIS PHARMA | E | N | 17/09/2020 |
23 | DESLORATADINE GENEPHARM | DESLORATADINE | 2,5 MG | Comprimé orodispersible | B/30 | GENEPHARM | E | N | 21/09/2020 |
24 | VENCLYXTO | VENETOCLAX | 10 mg | COMP PEL | B/14 | ABBVIE ltd | N | 09/10/2020 | |
25 | VENCLYXTO | VENETOCLAX | 50 mg | COMP PEL | B/7 | ABBVIE ltd | N | 09/10/2020 | |
26 | VENCLYXTO | VENETOCLAX | 100 mg | COMP PEL | B/7 | ABBVIE ltd | N | 09/10/2020 | |
27 | VENCLYXTO | VENETOCLAX | 100 mg | COMP PEL | B/14 | ABBVIE ltd | N | 09/10/2020 | |
28 | SIMULECT | BASILIXIMAB | 20 MG | Poudre pour prep injectable | B/ 1FL +S/5ML | NOVARTIS PHARMA | V | N | 15/10/2020 |
29 | TOT'HEMA | CUIVRE+ MANGANESE +FER | 0,7MG/ 1,33MG/ 50MG | SOLUTION BUVABLE | B/20 AMP/10ML | INNOTECH | E | N | 20/10/2020 |
30 | ALECENSA | ALECTINIB | 150 MG | GELULE | B/224 | ROCHE PHARMA (SCHWEIZ) LTD SUISSE | N | 23/10/2020 | |
31 | FORXIGA | DAPAGLIFLOZINE | 5 MG | COMP PEL | B/28 | ASTRA ZENECA | N | 02/11/2020 | |
32 | FORXIGA | DAPAGLIFLOZINE | 10 MG | COMP PEL | B/28 | ASTRA ZENECA | N | 02/11/2020 | |
33 | CETROTIDE | CETRORELIX | 0,25 MG | Poudre pour prep injectable | B/1 FL+SER/1ML | MERCK EUROPE BV | T | 05/11/2020 | |
34 | CYCLOGEST | PROGESTERONE | 400 MG | SUPPOSITOIRE | B/15 | L.D.Collins & Co.ltd | N | 06/11/2020 | |
35 | RILUZOLE MYLAN | RILUZOLE | 50 MG | COMP PELLICULE | B/56 | MYLAN S.A.S | N | 16/11/2020 | |
36 | PRADAXA | DABIGATRAN | 110 MG | GELULE | B/30 | BOEHRINGER INGELHEIM | V | 30/11/2020 | |
37 | PRADAXA | DABIGATRAN | 110 MG | GELULE | B/60 | BOEHRINGER INGELHEIM | V | 30/11/2020 | |
38 | PRADAXA | DABIGATRAN | 150 MG | GELULE | B/60 | BOEHRINGER INGELHEIM | N | 30/11/2020 | |
39 | JANUVIA | SITAGLIPTINE | 100 MG | COMPRIME PELLICULE | B/28 | MERCK SHARP & DOHME BV | E | T | 11/12/2020 |
* 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 | TECENTRIQ | ATEZOLIZUMAB | 1200mg | SOL INJ | B/1FL/20ML | ROCHE PHARMA (SCHWEIZ) LTD SUISSE | E | N | RE du 23/07/2020 |
2 | THYROFIX | LEVOTHYROXINE | 75µG | COMP PEL | B/30 | UNI PHARMA GRECE | E | N | RE du 03/08/2020 |
3 | THYROFIX | LEVOTHYROXINE | 25µG | COMP PEL | B/30 | UNI PHARMA GRECE | E | N | RE du 03/08/2020 |
4 | VIACORAM | PERINDOPRIL ARGININE+AMLODIPINE | 3,5 MG/2,5MG | COMP PELL | B/30 | SERVIER France | E | N | RE du 03/08/2020 |
5 | VIACORAM | PERINDOPRIL ARGININE+AMLODIPINE | 7 MG/5 MG | COMP PELL | B/30 | SERVIER France | E | N | RE du 03/08/2020 |
6 | ANAPEN | ADRENALINE | 300 µg/0,3 ml | SOL INJ | B/2 | BIOPROJET PHARMA | T | 05/08/2020 | |
7 | ANAPEN | ADRENALINE | 150 µg/0,3ml | SOL INJ | B/2 | BIOPROJET PHARMA | T | 05/08/2020 | |
8 | ARCHIFAR | MEROPENEME | 1 GR | PouDRE P PREPARATION INJECTABLE | b/1 fl | MEDOCHEMIE CHYPRE | E | N | RE du 11/08/2020 |
9 | ARCHIFAR | MEROPENEME | 0,5 GR | POUDRE POURPREPARATION INJECTABLE | b/1 fl | MEDOCHEMIE CHYPRE | E | N | RE du 11/08/2020 |
10 | MIRATA | ERLOTINIB | 100 MG | COMPRIME PELLICULE | B/30 | HIKMA PHARMACEUTICAL JORDANI | N | 28/08/2020 | |
11 | MIRATA | ERLOTINIB | 150 MG | COMPRIME PELLICULE | B/30 | HIKMA PHARMACEUTICAL JORDANI | N | 28/08/2020 | |
12 | ZYDEX B | ACIDE FUSIDIQUE + BETAMETHASONE | 2%-0,1% | CREME | T/15 G | BEIT JALA/ PALESTINE | N | 28/08/2020 | |
13 | ZYDEX HC | ACIDE FUSIDIQUE + HYDROCORTISONE | 2%-1% | CREME | T/15 G | BEIT JALA/ PALESTINE | N | 28/08/2020 | |
14 | SILDENAFIL MYLAN | SILDENAFIL (citrate) | 25 MG | COMPRIME PELLICULE | B/08 | MYLAN France | C | N | 22/09/2020 |
15 | SILDENAFIL MYLAN | SILDENAFIL (citrate) | 25 MG | COMPRIME PELLICULE | B/04 | MYLAN France | C | N | 22/09/2020 |
16 | SILDENAFIL MYLAN | SILDENAFIL (citrate) | 50 MG | COMPRIME PELLICULE | B/08 | MYLAN France | C | N | 22/09/2020 |
17 | SILDENAFIL MYLAN | SILDENAFIL (citrate) | 50 MG | COMPRIME PELLICULE | B/04 | MYLAN France | C | N | 22/09/2020 |
18 | SILDENAFIL MYLAN | SILDENAFIL (citrate) | 50 MG | COMPRIME PELLICULE | B/12 | MYLAN France | C | N | 22/09/2020 |
19 | SILDENAFIL MYLAN | SILDENAFIL (citrate) | 100 MG | COMPRIME PELLICULE | B/12 | MYLAN France | C | N | 22/09/2020 |
20 | SILDENAFIL MYLAN | SILDENAFIL (citrate) | 100 MG | COMPRIME PELLICULE | B/04 | MYLAN France | C | N | 22/09/2020 |
21 | SILDENAFIL MYLAN | SILDENAFIL (citrate) | 100 MG | COMPRIME PELLICULE | B/08 | MYLAN France | C | N | 22/09/2020 |
22 | D-CURE FORTE | CHOLECALCIFEROL | 100 000 UI/ML | SOLUTION BUVABLE | B/3 | SMB S.A | N | 22/09/2020 | |
23 | ULTIBRO BREEZHALER | INDACAD2ROL MALEATE+ BROMURE DE GLYCOPYRRONIUM | 85 µg+ 43 µg | poudre pour inhalation buccale | B/30 | NOVARTIS PHARMA (RU) | E | T | 29/09/2020 |
24 | SEEBRI BREEZHALER | BROMURE DE GLYCOPYRRONIUM | 44 µg | poudre pour inhalation buccale | B/30 | NOVARTIS EUROPHARM LIMITID Irlande | E | T | 07/10/2020 |
25 | VOTRIENT | PAZOPANID | 400 MG | COMPRIME PELLICULE | F/30 | NOVARTIS EUROPHARM LIMITID Irlande | T | 14/10/2020 | |
26 | VOTRIENT | PAZOPANID | 200 MG | COMPRIME PELLICULE | F/30 | NOVARTIS EUROPHARM LIMITID Irlande | T | 14/10/2020 | |
27 | REVOLADE | ELTROMBOPAG | 25 MG | COMPRIME PELLICULE | B/28 | NOVARTIS EUROPHARM LIMITID Irlande | T | 21/10/2020 | |
28 | REVOLADE | ELTROMBOPAG | 50 MG | COMPRIME PELLICULE | B/28 | NOVARTIS EUROPHARM LIMITID Irlande | T | 21/10/2020 | |
29 | XAPRINE | CYCLOBENZAPRINE | 10 MG | COMPRIME PELLICULE | B/30 | BEIT JALA/ PALESTINE | I | N | 27/10/2020 |
30 | DROSETUX | PRODUIT HOMEOPATHIQUE | SIROP | F/150 ML | BOIRON | C | V | 10/11/2020 | |
31 | HEMLIBRA | EMICIZUMAB | 60 MG/0,4ML | SOLUTION INJECTABLE | F/3ML | ROCHE PHARMA (SCHWEIZ) AG | V | N | 17/11/2020 |
32 | HEMLIBRA | EMICIZUMAB | 105 MG/0,7ML | SOLUTION INJECTABLE | F/3ML | ROCHE PHARMA (SCHWEIZ) AG | V | N | 17/11/2020 |
33 | HEMLIBRA | EMICIZUMAB | 150 MG/ML | SOLUTION INJECTABLE | F/3ML | ROCHE PHARMA (SCHWEIZ) AG | V | N | 17/11/2020 |
34 | HEMLIBRA | EMICIZUMAB | 30 MG/ML | SOLUTION INJECTABLE | F/1ML | ROCHE PHARMA (SCHWEIZ) AG | V | N | 17/11/2020 |
35 | TARKA FORTE | VERAPAMIL+ TRANDOLAPRIL | 240 MG/4MG | COMPRIME PELLICULE | B/28 | ABBOT-TURQUIE | E | N | 24/11/2020 |
36 | TARKA | VERAPAMIL+ TRANDOLAPRIL | 180 MG/2MG | COMPRIME PELLICULE | B/28 | ABBOT-TURQUIE | E | N | 24/11/2020 |
37 | ECALTA | ANIDULAFUNGINE | 100 MG | POUDRE POUR PREPARATION INJECTABLE | B/1 FL | PFIZER | T | 25/11/2020 | |
38 | ZINFORO | CEFTAROLINE FOSAMIL | 600 MG | POUDRE POUR PREPARATION INJECTABLE | B/10FL | PFIZER IRELAND PHARMACEUTICALS | V | 25/11/2020 | |
39 | VESSEL | SULODEXIDE | 250 ULS | CAPSULE MOLLE | B/50 | ALFA WASSERMANN Italie | V | 03/12/2020 | |
40 | STODAL | Médicament homéopathique | sirop | FL/200ML | BOIRON | V | 03/12/2020 | ||
41 | BOTOX | TOXINE BOTULINIQUE | 100 UNITES ALLERGAN | POUDRE POUR SOLUTION INJECTABLE | B/1F | ALLERGAN LTD, | V | 03/12/2020 | |
42 | LUCENTIS | RANIBIZUMAB | 10 MG/ML | SOLUTION INJECTABLE | B/1FL/0,23ML | NOVARTIS PHARMA SCHWEIZ AG | V | 03/12/2020 | |
43 | SYNTHOL | LEVOMENTHOL+ VERATROLE + RESORCINOL+ ACIDE SALICYLIQUE | 260 MG/260 MG/21 MG/10,5 MG | SOLUTION POUR APPLICATION CUTANEE | 1FL DE 225ML | GLAXOSMITHKLINE SANTE GRAND PUBLIC | V | 03/12/2020 | |
44 | COCCULINE | MEDICAMENT HOMEOPATHIQUE | COMPRIME ORODISPERSIBLE | B/40 | BOIRON | V | 03/12/2020 | ||
45 | AVAMYS | FUROATE DE FLUTICASONE | 27,5 mcg/ pulvérisation | suspension pour pulvérisation nasale | F/120 PUL | GLAXOSMITHKLINE (IRELAND) LIMITED | E | T | 07/12/2020 |
46 | MAVENCLAD | CLADRIBINE | 10 MG | COMPRIME | B/1 | MERCK EUROPE B,V | T | 08/12/2020 | |
47 | MAVENCLAD | CLADRIBINE | 10 MG | COMPRIME | B/4 | MERCK EUROPE B,V | T | 08/12/2020 | |
48 | MAVENCLAD | CLADRIBINE | 10 MG | COMPRIME | B/6 | MERCK EUROPE B,V | T | 08/12/2020 | |
49 | IMBRUVICA | IBRUTINIB | 140 MG | GELULES | B/90 | JANSSEN-CILAG | E | V | 15/12/2020 |
50 | CUREAML | HYDROXYCARBAMIDE | 500 MG | GELULES | B/30 | HIKMA PHARMACEUTICAL JORDANI | V | V | 15/12/2020 |
51 | PROTHROMPLEX | FACTEUR IX II VII X | 600 I,U, | poudre et solvant pour préparation injectable | B/1FL+S/20ML | BAXTER AG | V | V | 15/12/2020 |