Dossiers d'AMM à étudier par le Comité Technique des Spécialités Pharmaceutiques du 07/07/2021.
Pour ce comité technique, l’ordre de passage des dossiers sera comme suit .
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 Rapport |
1 | GALVINE | VILDAGLIPTINE | 50 mg | Comprimé | B/30 |
SAIPH | E | N | 15/06/2021 |
* Produits à évaluer pour la première fois au Comité Technique
N° | Médicament | DCI | Dosage | Forme Pharmaceutique | Présentation | TITULAIRE | VEIC | Type de demande | DATE Rapport |
1 | DAPOX | DAPOXETINE | 30 mg | COMPRIMÉ PELLICULÉ | B/3 | TERIAK | C | N | 15/06/2021 |
2 | DAPOX | DAPOXETINE | 30 mg | COMPRIMÉ PELLICULÉ | B/6 | TERIAK | C | N | 15/06/2021 |
3 | DAPOX | DAPOXETINE | 60 mg | COMPRIMÉ PELLICULÉ | B/3 | TERIAK | C | N | 15/06/2021 |
4 | DAPOX | DAPOXETINE | 60 mg | COMPRIMÉ PELLICULÉ | B/6 | TERIAK | C | N | 15/06/2021 |
5 | PSODERM PLUS | CALCIPOTRIOL+BETAMETHASONE | 50 mcg/0.5mg/gr | POMMADE DERMIQUE | FL/60 gr | PHARMAGHREB | E | N | 15/06/2021 |
6 | RABEZOL | RABEPRAZOLE | 20 mg | COMPRIMÉ GASTRO-RÉSISTANT | B/14 | PHARMAGHREB | E | N | 15/06/2021 |
7 | RABEZOL | RABEPRAZOLE | 20 mg | COMPRIMÉ GASTRO-RÉSISTANT | B/28 | PHARMAGHREB | E | N | 15/06/2021 |
8 | DAFLON | DIOSMINE+HESPERIDINE | 1000 mg | COMPRIMÉ PELLICULÉ | B/30 | TERIAK | C | N | 24/06/2021 |
9 | REDUSPASM | PHLOROGLUCINOL DIHYDRATE | 80 mg | COMPRIMÉ ORODISPERSIBLE | B/30 | MEDIS | I | N | 24/06/2021 |
11 | NOVALIP | FENOFIBRATE | 160 mg | Gélule | B/30 | ADWYA | E | N | 02/07/2021 |
12 | ALGESIC PEDIATRIQUE | PARACETAMOL | 3% | SOL BUVABLE | FL/90 ML | DAR ESSAYDALI | E | N | 02/07/2021 |
13 | NEBICOR | NEBIVOLOL | 5 mg | Comp quadri-secable | B/30 | ADVANS PHARMA | E | N | 02/07/2021 |
Spécialités Pharmaceutiques importée
* Produits déjà évalués lors des derniers Comités Techniques
N° | Médicament | DCI | Dosage | Forme Pharmaceutique | Présentation | TITULAIRE | VEIC | Type de demande | date du courrier |
1 | XERACTAN | ISOTRETINOINE | 10 MG | CAPSULE MOLLE | B/30 | JAZEERA PHARMACEUTICAL INDUSTRIES | I | N | 08/02/2021 |
2 | XERACTAN | ISOTRETINOINE | 20 MG | CAPSULE MOLLE | B/30 | JAZEERA PHARMACEUTICAL INDUSTRIES | I | N | 08/02/2021 |
3 | JANUMET | SITAGLIPTINE + METFORMINE | 50 mg/1000 mg | comprimé | B/56 | MERCK SHARP & DOHME BV | E | T | 17/02/2021 |
4 | FOSAVANCE | ALENDRONATE+COLECALCIFEROL | 70 mg/5000 UI Cp | Comprimé | B/4 | MERCK SHARP & DOHME BV | E | T | 17/02/2021 |
5 | HEMLIBRA | EMICIZUMAB | 30mg/ml | SOL INJ | B/1FL/1ML | Roche Pharma (Schweiz) AG | V | N | 24/03/2021 |
6 | HEMLIBRA | EMICIZUMAB | 150mg/ml | SOL INJ | B/1FL/1ML | Roche Pharma (Schweiz) AG | V | N | 24/03/2021 |
7 | HEMLIBRA | EMICIZUMAB | 105 mg / 0,7ml | SOL INJ | B/1FL/3ML | Roche Pharma (Schweiz) AG | V | N | 24/03/2021 |
8 | HEMLIBRA | EMICIZUMAB | 60 mg / 0,4ml | SOL INJ | B/1FL/3ML | Roche Pharma (Schweiz) AG | V | N | 24/03/2021 |
9 | OXYCONTIN | OXYCODONE | 10mg | CP à liberation prolongée | B/20 | PURDUE PHARMA | V | E | 27/04/2021 |
10 | OXYCONTIN | OXYCODONE | 15mg | CP à liberation prolongée | B/20 | PURDUE PHARMA | V | E | 27/04/2021 |
11 | OXYCONTIN | OXYCODONE | 20mg | CP à liberation prolongée | B/20 | PURDUE PHARMA | V | E | 27/04/2021 |
12 | OXYCONTIN | OXYCODONE | 30mg | CP à liberation prolongée | B/20 | PURDUE PHARMA | V | E | 27/04/2021 |
13 | OXYCONTIN | OXYCODONE | 40mg | CP à liberation prolongée | B/20 | PURDUE PHARMA | V | E | 27/04/2021 |
14 | TECENTRIQ | ATEZOLIZUMAB | 1200 mg | SOL INJ P PERFUSION | B/1FL/20 ml | ROCHE SUISSE | V | N | 05/05/2021 |
15 | VOTRIENT | PAZOPANIB | 200 MG | COMP | B/30 | NOVARTIS PHARMA | V | N | 17/05/2021 |
16 | VOTRIENT | PAZOPANIB | 400 MG | COMP | B/30 | NOVARTIS PHARMA | V | N | 17/05/2021 |
17 | SEROQUEL XL | QUETIAPINE | 50 MG | COMP LP | B/60 | ASTRA ZENECA UK | E | V | 31/05/2021 |
18 | SEROQUEL XL | QUETIAPINE | 400 MG | COMP LP | B/60 | ASTRA ZENECA UK | E | V | 31/05/2021 |
19 | SEROQUEL XL | QUETIAPINE | 300 MG | COMP LP | B/60 | ASTRA ZENECA UK | E | V | 31/05/2021 |
20 | SEROQUEL XL | QUETIAPINE | 200 MG | COMP LP | B/60 | ASTRA ZENECA UK | E | V | 31/05/2021 |
21 | SUXAMETHONIUM CHLORID VUAB | SUXAMETHONIUM | 100 mg | PDRE PR SUSP INJ | B/1FL | VUAB PHARMA AS | V | N | 02/06/2021 |
LUCENTIS | RANIBIZUMAB | 10MG/ML | SOL INJ | B/1FL | NOVARTIS PHARMA | E | V | 02/06/2021 | |
22 | ARCHIFAR | MEROPENEME | 1 GR | PDRE PR SOL INJ | B/1FL | MEDOCHEMIE CHYPRE | N | E | 15/06/2021 |
23 | ARCHIFAR | MEROPENEME | 0,5 GR | PDRE PR SOL INJ | B/1FL | MEDOCHEMIE CHYPRE | N | E | 15/06/2021 |
24 | LEUPRO-SANDOZ DÉPOT 1 MOIS | LEUPRORELINE | 3.6 mg | SERINGUE PRE REML | B/1 | Sandoz Pharma GmbH Allemagne | N | V | 22/06/2021 |
25 | LEUPRO-SANDOZ DÉPOT 3 MOIS | LEUPRORELINE | 5 mg | SERINGUE PRE REML | B/1 | Sandoz Pharma GmbH Allemagne | N | V | 22/06/2021 |
* 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 | INTRATECT | IMMUNOGLOBULINE HUMAINE POLYVALENTE | 5G/100ML | SOLUTION INJECTABLE POU PERFUSION | FL/100ML | BIOTEST PHARMA GMBH | E | V | 29/12/2020 |
2 | INTRATECT | IMMUNOGLOBULINE HUMAINE POLYVALENTE | 2,5G/50ML | SOLUTION INJECTABLE POU PERFUSION | FL/50ML | BIOTEST PHARMA GMBH | E | V | 29/12/2020 |
3 | LOXEN LP | NICARDIPINE | 50 MG | GELULES | B/60 | CARDIXO- France | E | T | 11/01/2021 |
4 | ZEFFIX | LAMIVUDINE | 100 MG | COMPRIME PELLICULE | B/28 | GLAXOSMITHKLINE (IRELAND) LIMITED | T | 11/01/2021 | |
5 | VICTOZA | LIRAGLUTIDE | 6 MG/ML | SOLUTION INJECTABLE | B/2 STYLOS DE 3ML | NOVO NORDISK A/S | V | V | 12/01/2021 |
6 | RHESONATIV | ANTI-D(RH) immunoglobuline | 625 IU/ML | SOLUTION INJECTABLE | B/1 AMP/2ML | OCTAPHARMA AB | E | V | 12/01/2021 |
7 | NEXIUM | ESOMEPRAZOLE | 40 MG | COMPRIME GASTRO-RESISTANT | B/28 | ASTRAZENECA UL,LTD | E | T | 12/01/2021 |
8 | POLYGYNAX | NEOMYCINE+ NYSTATINE+ POLYMYXINE B | CAPSULE VAGINALE | B/6 | INNOTECH INTERNATIONAL | I | V | 12/01/2021 | |
9 | DIOVENOR | DIOSMINE | 600 MG | COMPRIME PELLICULE | B/30 | INNOTHERA France | C | N | 25/01/2021 |
10 | FORLAX | POLYETHYLENE GLYCOL | 4G | POUDRE POUR SOLUTION ORALE | B/20 | IPSEN CONSUMER HEALTHCARE France | C | T | 25/01/2021 |
11 | NASOALDO | MOMETASONE FUROATE MONOHYDRATE | 50 µg | suspension pour pulvérisation nasale | F/140 DOSES | ALDO UNION S,L- Espagne | N | 05/02/2021 | |
12 | FORTACIN | LIDOCAINE + PRILOCAINE | 150 mg/ML + 50mg /ml | solution cutanée | FL/ 5ML | RECORDATI - IRELAND | N | 22/02/2021 | |
13 | GENEMENT | TADALAFIL | 20 mg | comprimé | B/4 | GENEPHARM S.A | C | N | 04/03/2021 |
14 | GENEMENT | TADALAFIL | 10 mg | comprimé | B/4 | GENEPHARM S.A | C | N | 04/03/2021 |
15 | ACETETE DE TERLIPRESSINE EVER PHARMA | TERLIPRESSINE | 0.2 mg/ml | SOL INJ | B/5 | EVER Valinject GmbH | E | N | 04/03/2021 |
16 | MONCAS | MONTELUKAST | 5 MG | COMP PEL | B/28 | GENEPHARM S.A | E | N | 25/03/2021 |
17 | MONCAS | MONTELUKAST | 10 MG | COMP PEL | B/28 | GENEPHARM S.A | E | N | 25/03/2021 |
18 | MONCAS | MONTELUKAST | 4 MG | COMP PEL | B/28 | GENEPHARM S.A | E | N | 25/03/2021 |
19 | VIAGRA | SILDENAFIL | 100 MG | COMP PEL | B/4 | Upjohn EESV | C | T | 26/03/2021 |
20 | VIAGRA | SILDENAFIL | 25MG | COMP PEL | B/4 | Upjohn EESV | C | T | 26/03/2021 |
21 | VIAGRA | SILDENAFIL | 50 MG | COMP PEL | B/4 | Upjohn EESV | C | T | 26/03/2021 |
22 | LYRICA | PREGABALINE | 75 mg | GELULES | B/56 | Upjohn EESV | V | T | 29/03/2021 |
23 | LYRICA | PREGABALINE | 75 mg | GELULES | B/14 | Upjohn EESV | V | T | 29/03/2021 |
24 | LYRICA | PREGABALINE | 150mg | GELULES | B/56 | Upjohn EESV | V | T | 29/03/2021 |
25 | SUFENTA | SUFENTANIL | 250 µg/5ml | SOL INJ | B/10/5 ml | Piramal Critical Care B.V. | V | T | 31/03/2021 |
26 | EXTEMENT | SILDENAFIL | 25 MG | COMP | B/4 | GENEPHARM S.A | C | N | 01/04/2021 |
27 | EXTEMENT | SILDENAFIL | 100 MG | COMP | B/4 | GENEPHARM S.A | C | N | 01/04/2021 |
28 | EXTEMENT | SILDENAFIL | 50 MG | COMP | B/4 | GENEPHARM S.A | C | N | 01/04/2021 |
29 | XALKORI | CRIZOTINIB | 250 MG | GELULES | FL/60 | PF PRISM C.V | V | V | 01/04/2021 |
30 | XALKORI | CRIZOTINIB | 200 MG | GELULES | FL/60 | PF PRISM C.V | V | V | 01/04/2021 |
31 | KISQALI | RIBOCICLIB SUCCINATE | 200 MG | COMP PEL | B/63 | NOVARTIS PHARMA SCHWEIZ AG | V | V | 01/04/2021 |
32 | IBRANCE | PALBOCICLIB | 125 MG | GELULES | FL/21 | PFIZER INC USA | E | V | 01/04/2021 |
33 | IBRANCE | PALBOCICLIB | 100 MG | GELULES | FL/21 | PFIZER INC USA | E | V | 01/04/2021 |
34 | IBRANCE | PALBOCICLIB | 75 MG | GELULES | FL/21 | PFIZER INC USA | E | V | 01/04/2021 |
35 | FASLODEX | FULVESTANT | 250 mg | SOL INJ | B/2/5ML | ASTRAZENECA UL,LTD | V | V | 01/04/2021 |
36 | ECALTA | ANIDULAFUNGINE | 100 MG | POUDRE POUR PREPARATION INJECTABLE | B/1 FL | PFIZER | T | 14/04/2021 | |
37 | XANAX | ALPRAZOLAM | 0,75 | Gouttes buv | B/1FL/20ml | Upjohn SRL | I | T | |
38 | RAPIFEN | ALFENTANIL | 1 mg (0.5mg/ml) | SOL INJ | B/5/2 ML | Piramal Critical Care B.V. | V | T | 21/04/2021 |
39 | TREMFYA | GUSELKUMAB | 100mg | SOL INJ | B/1SERINGUE | Janssen-Cilag International N.V | N | 27/04/2021 | |
40 | HUMIRA | ADALIMUMAB | 80 mg | SOL INJ | B/1 stylo pré-rempli/0.8 ml | ABBVIE DEUTSCHLAND Gmbh and Co.KG | E | N | 27/04/2021 |
41 | HUMIRA | ADALIMUMAB | 40 mg | SOL INJ | B/2stylo pré-rempli/0.4 ml | ABBVIE DEUTSCHLAND Gmbh and Co.KG | E | N | 27/04/2021 |
42 | HUMIRA | ADALIMUMAB | 20 mg | SOL INJ | B/2SERINGUE/0,2ML | ABBVIE DEUTSCHLAND Gmbh and Co.KG | E | N | 27/04/2021 |
43 | PANTONIX | PANTOPRAZOLE | 40 MG | PDRE PR PREP INJ | B/1FL | JULPHAR | E | N | 17/05/2021 |
44 | CEFODOX | CEFPODOXIME PROXETIL | 100 MG | COMP PEL | B/10 | PHARMA INTERNATIONAL COMPANY | E | V | 19/05/2021 |
45 | CEFODOX | CEFPODOXIME PROXETIL | 200 MG | COMP PEL | B/10 | PHARMA INTERNATIONAL COMPANY | E | V | 19/05/2021 |
46 | PEMZEK PLUS | CANDESARTAN+HYDROCHLOROTHIAZIDE | 8/12,5 MG | COMP PEL | B/28 | ASTRAZENECA SUISSE | E | T | 21/05/2021 |
47 | PEMZEK PLUS | CANDESARTAN+HYDROCHLOROTHIAZIDE | 16/12,5 MG | COMP PEL | B/28 | ASTRAZENECA SUISSE | E | T | 21/05/2021 |
48 | OVITRELLE | GONADOTROPHINE CHORIONIQUE | 250 MCG/0.5ml | SERINGUE | B/1 /0.5ml | MERCK EUROPE B.V | E | T | 31/05/2021 |
49 | DYMISTA | CHLORHYDRATE D'AZELASTINE+PROPIONATE DE FLUCTICASONE | 137 microgrammes / 50 microgra | Susp oral | B/1FL | MEDA PHARMA | I | N | 28/05/2021 |
50 | BETOPTIC | BETAXOLOL | 0.5% | Collyre | FL/5ML | NOVARTIS PHARMA NV | E | N | 28/05/2021 |
51 | MAXITROL | DEXAMETHASONE+NEOMYCINE+POLYMYXINE B | Collyre | FL/5 ML | NOVARTIS PHARMA SCHWEIZ AG | E | N | 28/05/2021 | |
52 | TRIMBOW | BECLOMETHASONE+FORMOTEROL+GLYCOPYRRONIUM | 87 µg/5 µg/9 µg | SOL PR INH | FL/120 doses | CHIESI FARMACEUTICI S.p.A | E | N | 28/05/2021 |
53 | FLUCON | FLUOROMETHOLONE | 0.1% | Collyre | FL/5ML | NOVARTIS PHARMA NV | E | N | 28/05/2021 |
54 | MYCAMINE | MICAFUNGINE | 50 MG | PDRE PR SOL PR PERFUSION | B/ 1FL/10ML | ASTELLAS PHARMA EUROPE B.V HOLLANDE | E | N | 28/05/2021 |
55 | MYCAMINE | MICAFUNGINE | 100 MG | PDRE PR SOL PR PERFUSION | B/ 1FL/10ML | ASTELLAS PHARMA EUROPE B.V HOLLANDE | E | N | 28/05/2021 |