Dossiers d'AMM à étudier par le Comité Technique des Spécialités Pharmaceutiques du 15/09/2021.
Pour ce comité technique, l’ordre de passage des dossiers sera comme suit .
Spécialités Pharmaceutiques fabriquées localement :
* 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 | MEDICAINE 3% SANS VASOCONSTRIC | MEPIVACAINE | 3% | Solution injectable | B/25 CARPULES/1.8ML | LES LABORATOIRES MEDIS | E | N | 18/06/2021 |
2 | ALGESIC GRIPPE | PARACETAMOL+PHENIRAMINE+ VITAMINE C | 500 mg/200 mg/25 mg | Poudre pour solution orale | B/8 SACHETS | DAR-ESSAYDALI. | C | N | 31/08/2021 |
3 | PREDNICORT | PREDNISOLONE | 5 mg | Comprimé orodispersible | B/30 | PHARMACARE | E | N | 06/09/2021 |
4 | FRESIDOL | PARACETAMOL | 3% | Suspension buvable | FL/90 ml | PHARMADERM | E | V | 06/09/2021 |
5 | PERILAX | LACTULOSE | 66.5 % | Solution buvable | FL/120ML | PHARMADERM | C | N | 10/09/2021 |
6 | WINDOL EXTRA | PARACETAMOL+CAFEINE | 500 mg/65 mg | Comprimé pelliculé | B/16 | TERIAK | E | N | 10/09/2021 |
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 | 60mg | CP à liberation prolongée | B/20 | PURDUE PHARMA | V | E | 27/04/2021 |
14 | OXYCONTIN | OXYCODONE | 80mg | CP à liberation prolongée | B/20 | PURDUE PHARMA | V | E | 27/04/2021 |
15 | OXYCONTIN | OXYCODONE | 40mg | CP à liberation prolongée | B/20 | PURDUE PHARMA | V | E | 27/04/2021 |
16 | TECENTRIQ | ATEZOLIZUMAB | 1200 mg | SOL INJ P PERFUSION | B/1FL/20 ml | ROCHE SUISSE | V | N | 05/05/2021 |
17 | VOTRIENT | PAZOPANIB | 200 MG | COMP | B/30 | NOVARTIS PHARMA | V | N | 17/05/2021 |
18 | VOTRIENT | PAZOPANIB | 400 MG | COMP | B/30 | NOVARTIS PHARMA | V | N | 17/05/2021 |
19 | PRILIGY | DAPOXETINE | 30 mg | COMP PL | B/3 | MENARINI Ind.Farmaceutiche Riunite SRL | V | N | 25/05/2021 |
20 | PRILIGY | DAPOXETINE | 60 mg | COMP PL | B/3 | MENARINI Ind.Farmaceutiche Riunite SRL | V | N | 25/05/2021 |
21 | SEROQUEL XL | QUETIAPINE | 50 MG | COMP LP | B/60 | ASTRA ZENECA UK | E | V | 31/05/2021 |
22 | SEROQUEL XL | QUETIAPINE | 400 MG | COMP LP | B/60 | ASTRA ZENECA UK | E | V | 31/05/2021 |
23 | SEROQUEL XL | QUETIAPINE | 300 MG | COMP LP | B/60 | ASTRA ZENECA UK | E | V | 31/05/2021 |
24 | SEROQUEL XL | QUETIAPINE | 200 MG | COMP LP | B/60 | ASTRA ZENECA UK | E | V | 31/05/2021 |
25 | RANEXA | RANOLAZINE | 750 mg | COMP LP | B/60 | Menarini International Operation Luxembourg S.A | E | N | 01/06/2021 |
26 | RANEXA | RANOLAZINE | 500 mg | COMP LP | B/60 | Menarini International Operation Luxembourg S.A | E | N | 01/06/2021 |
27 | SUXAMETHONIUM CHLORID VUAB | SUXAMETHONIUM | 100 mg | PDRE PR SUSP INJ | B/1FL | VUAB PHARMA AS | V | N | 02/06/2021 |
28 | LUCENTIS | RANIBIZUMAB | 10MG/ML | SOL INJ | B/1FL | NOVARTIS PHARMA | E | V | 02/06/2021 |
29 | ARCHIFAR | MEROPENEME | 1 GR | PDRE PR SOL INJ | B/1FL | MEDOCHEMIE CHYPRE | N | E | 15/06/2021 |
30 | ARCHIFAR | MEROPENEME | 0,5 GR | PDRE PR SOL INJ | B/1FL | MEDOCHEMIE CHYPRE | N | E | 15/06/2021 |
31 | LEUPRO-SANDOZ DÉPOT 1 MOIS | LEUPRORELINE | 3.6 mg | SERINGUE PRE REML | B/1 | Sandoz Pharma GmbH Allemagne | N | V | 22/06/2021 |
32 | 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 | PERGOVERIS | FSH+LH | 150 UI/75UI | Pdre p prep Injectable | B/1 FL | MERCK EUROPE B.V | E | T | 43595 |
2 | FORTACIN | LIDOCAINE + PRILOCAINE | 150 mg/ML + 50mg /ml | solution cutanée | FL/ 5ML | RECORDATI - IRELAND | N | 22/02/2021 | |
3 | GENEMENT | TADALAFIL | 20 mg | comprimé | B/4 | GENEPHARM S.A | C | N | 04/03/2021 |
4 | GENEMENT | TADALAFIL | 10 mg | comprimé | B/4 | GENEPHARM S.A | C | N | 04/03/2021 |
5 | ACETETE DE TERLIPRESSINE EVER PHARMA | TERLIPRESSINE | 0.2 mg/ml | SOL INJ | B/5 | EVER Valinject GmbH | E | N | 04/03/2021 |
6 | MONCAS | MONTELUKAST | 5 MG | COMP PEL | B/28 | GENEPHARM S.A | E | N | 25/03/2021 |
7 | MONCAS | MONTELUKAST | 10 MG | COMP PEL | B/28 | GENEPHARM S.A | E | N | 25/03/2021 |
8 | MONCAS | MONTELUKAST | 4 MG | COMP PEL | B/28 | GENEPHARM S.A | E | N | 25/03/2021 |
9 | VIAGRA | SILDENAFIL | 100 MG | COMP PEL | B/4 | Upjohn EESV | C | T | 26/03/2021 |
10 | VIAGRA | SILDENAFIL | 25MG | COMP PEL | B/4 | Upjohn EESV | C | T | 26/03/2021 |
11 | VIAGRA | SILDENAFIL | 50 MG | COMP PEL | B/4 | Upjohn EESV | C | T | 26/03/2021 |
12 | LYRICA | PREGABALINE | 75 mg | GELULES | B/56 | Upjohn EESV | V | T | 29/03/2021 |
13 | LYRICA | PREGABALINE | 75 mg | GELULES | B/14 | Upjohn EESV | V | T | 29/03/2021 |
14 | LYRICA | PREGABALINE | 150mg | GELULES | B/56 | Upjohn EESV | V | T | 29/03/2021 |
15 | SUFENTA | SUFENTANIL | 250 µg/5ml | SOL INJ | B/10/5 ml | Piramal Critical Care B.V. | V | T | 31/03/2021 |
16 | EXTEMENT | SILDENAFIL | 25 MG | COMP | B/4 | GENEPHARM S.A | C | N | 01/04/2021 |
17 | EXTEMENT | SILDENAFIL | 100 MG | COMP | B/4 | GENEPHARM S.A | C | N | 01/04/2021 |
18 | EXTEMENT | SILDENAFIL | 50 MG | COMP | B/4 | GENEPHARM S.A | C | N | 01/04/2021 |
19 | XALKORI | CRIZOTINIB | 250 MG | GELULES | FL/60 | PF PRISM C.V | V | V | 01/04/2021 |
20 | XALKORI | CRIZOTINIB | 200 MG | GELULES | FL/60 | PF PRISM C.V | V | V | 01/04/2021 |
21 | KISQALI | RIBOCICLIB SUCCINATE | 200 MG | COMP PEL | B/63 | NOVARTIS PHARMA SCHWEIZ AG | V | V | 01/04/2021 |
22 | IBRANCE | PALBOCICLIB | 125 MG | GELULES | FL/21 | PFIZER INC USA | E | V | 01/04/2021 |
23 | IBRANCE | PALBOCICLIB | 100 MG | GELULES | FL/21 | PFIZER INC USA | E | V | 01/04/2021 |
24 | IBRANCE | PALBOCICLIB | 75 MG | GELULES | FL/21 | PFIZER INC USA | E | V | 01/04/2021 |
25 | FASLODEX | FULVESTANT | 250 mg | SOL INJ | B/2/5ML | ASTRAZENECA UL,LTD | V | V | 01/04/2021 |
26 | ECALTA | ANIDULAFUNGINE | 100 MG | POUDRE POUR PREPARATION INJECTABLE | B/1 FL | PFIZER | T | 14/04/2021 | |
27 | XANAX | ALPRAZOLAM | 0,75 | Gouttes buv | B/1FL/20ml | Upjohn SRL | I | T | |
28 | RAPIFEN | ALFENTANIL | 1 mg (0.5mg/ml) | SOL INJ | B/5/2 ML | Piramal Critical Care B.V. | V | T | 21/04/2021 |
29 | TREMFYA | GUSELKUMAB | 100mg | SOL INJ | B/1SERINGUE | Janssen-Cilag International N.V | N | 27/04/2021 | |
30 | 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 |
31 | HUMIRA | ADALIMUMAB | 40 mg | SOL INJ | B/2stylo pré-rempli/0.4 ml | ABBVIE DEUTSCHLAND Gmbh and Co.KG | E | N | 27/04/2021 |
32 | HUMIRA | ADALIMUMAB | 20 mg | SOL INJ | B/2SERINGUE/0,2ML | ABBVIE DEUTSCHLAND Gmbh and Co.KG | E | N | 27/04/2021 |
33 | PANTONIX | PANTOPRAZOLE | 40 MG | PDRE PR PREP INJ | B/1FL | JULPHAR | E | N | 17/05/2021 |
34 | CEFODOX | CEFPODOXIME PROXETIL | 100 MG | COMP PEL | B/10 | PHARMA INTERNATIONAL COMPANY | E | V | 19/05/2021 |
35 | CEFODOX | CEFPODOXIME PROXETIL | 200 MG | COMP PEL | B/10 | PHARMA INTERNATIONAL COMPANY | E | V | 19/05/2021 |
36 | PEMZEK PLUS | CANDESARTAN+HYDROCHLOROTHIAZIDE | 8/12,5 MG | COMP PEL | B/28 | ASTRAZENECA SUISSE | E | T | 21/05/2021 |
37 | PEMZEK PLUS | CANDESARTAN+HYDROCHLOROTHIAZIDE | 16/12,5 MG | COMP PEL | B/28 | ASTRAZENECA SUISSE | E | T | 21/05/2021 |
38 | OVITRELLE | GONADOTROPHINE CHORIONIQUE | 250 MCG/0.5ml | SERINGUE | B/1 /0.5ml | MERCK EUROPE B.V | E | T | 31/05/2021 |
39 | DYMISTA | CHLORHYDRATE D'AZELASTINE+PROPIONATE DE FLUCTICASONE | 137 microgrammes / 50 microgra | Susp oral | B/1FL | MEDA PHARMA | I | N | 28/05/2021 |
40 | BETOPTIC | BETAXOLOL | 0.5% | Collyre | FL/5ML | NOVARTIS PHARMA NV | E | N | 28/05/2021 |
41 | MAXITROL | DEXAMETHASONE+NEOMYCINE+POLYMYXINE B | Collyre | FL/5 ML | NOVARTIS PHARMA SCHWEIZ AG | E | N | 28/05/2021 | |
42 | 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 |
43 | FLUCON | FLUOROMETHOLONE | 0.1% | Collyre | FL/5ML | NOVARTIS PHARMA NV | E | N | 28/05/2021 |
44 | MYCAMINE | MICAFUNGINE | 50 MG | PDRE PR SOL PR PERFUSION | B/ 1FL/10ML | ASTELLAS PHARMA EUROPE B.V HOLLANDE | E | N | 28/05/2021 |
45 | MYCAMINE | MICAFUNGINE | 100 MG | PDRE PR SOL PR PERFUSION | B/ 1FL/10ML | ASTELLAS PHARMA EUROPE B.V HOLLANDE | E | N | 28/05/2021 |
46 | DEGAS | SIMETHICONE | 40mg/ml | EMULSION ORALE | B/1FL | AMMAN PHARMACEUTICAL INDUSTRIES | I | N | 24/06/2021 |
47 | SKYRIZI | RISANKIZUMAB | 75 mg | SOL INJ | B/2SERINGUE | ABBVIE DEUTSCHLAND Gmbh and Co.KG | N | 06/07/2021 | |
48 | AVENOC | PRODUITS HOMEOPATHIQUES | POMMADE RECTALE | T/30 G | BOIRON FRANCE | C | V | 15/06/2021 | |
49 | HOMEOVOX | SOUCHES HOMEOPATHIQUES | CP DRAGEIFIE | B/40 | BOIRON FRANCE | V | 12/07/2021 | ||
50 | BEMUX | BENDAMUSTINE | 25 MG | PDRE P,SOL INJECTABLE | B/1 FL | RICHMOND ARGENTINE | N | 13/07/2021 | |
51 | BEMUX | BENDAMUSTINE | 100 MG | PDRE P,SOL INJECTABLE | B/1FL | RICHMOND ARGENTINE | N | 13/07/2021 | |
52 | STODAL | SOUCHES HOMEOPATHIQUES | SIROP | FL/200 ML | BOIRON FRANCE | V | 13/07/2021 | ||
53 | UN-ALFA | ALFACALCIDOL | 1 µG | CAPSULE | B/30 | CHEPLAPHARM Arzneimittel GmbH | E | T | 14/07/2021 |
54 | UN-ALFA | ALFACALCIDOL | 0,25 µG | CAPSULE | B/30 | CHEPLAPHARM Arzneimittel GmbH | E | T | 14/07/2021 |
55 | ESMERON | ROCURONIUM BROMURE | 50 mg/5ml | SOL INJ | B/10 | MERCK SHARP & DOHME BV | T | 14/07/2021 | |
56 | GONAL-F | FSH | 75 UI (5.5 mcg) | PDRE PR PREP INJ | B/1 | MERCK EUROPE B.V | E | T | 16/08/2021 |
57 | UN-ALFA | ALFACALCIDOL | 1 µG | SOL INJ | B/10 AMP | CHEPLAPHARM Arzneimittel GmbH | E | T | 18/08/2021 |
58 | NASONEX | MOMETASONE | 50 MCG/DOSE | Susp NASAL | FL/140 DOSES | ORGANON TECHNIKA FRANCE | E | T | 09/08/2021 |