Dossiers d'AMM à étudier par le Comité Technique des Spécialités Pharmaceutiques du 18/05/2023.
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 | MIRAZINE | MIRTAZAPINE | 15 MG | Comprimé pelliculé sécable | B/30 | SAIPH | E | N | 04/05/2023 |
2 | THERAFENIB | SORAFENIB | 200 MG | Comprimé pelliculé | B/60 | THERA | V | N | 17/05/2023 |
* 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 | APIXAN | APIXABAN | 2,5 MG | Comprimé pelliculé | B/60 | PHARMACARE | E | N | 06/03/2023 |
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 | ZEFFIX | LAMIVUDINE | 100 MG | COMP PEL | B/28 | GSK IRELAND | E | T | 01/02/2023 |
2 | ARIXTRA | FONDAPARINUX SODIUM | 2.5mg/0.5ml (5mg/ml) | SOL INJ PR PERF | B/10 | ASPEN PHARMA TRADING Limited | N | 17/02/2023 | |
3 | ARIXTRA | FONDAPARINUX SODIUM | 7.5mg/0.6ml (12.5mg/ml) | SOL INJ PR PERF | B/10 | ASPEN PHARMA TRADING Limited | N | 17/02/2023 | |
4 | TRIMBOW | BECLOMETHASONE+FORMOTEROL+GLYCOPYRRONIUM | 87 µg/5 µg/9 µg | SOL PR INH | FL/120 | CHIESI FARMACEUTICI S.p.A | N | 17/02/2023 | |
5 | LISINOPRIL Atb | LISINOPRIL | 10mg | COMP | B/30 | ANTIBIOTICE S.A | E | N | 17/02/2023 |
6 | LISINOPRIL Atb | LISINOPRIL | 20mg | COMP | B/30 | ANTIBIOTICE S.A | E | N | 17/02/2023 |
7 | LISINOPRIL Atb | LISINOPRIL | 40mg | COMP | B/30 | ANTIBIOTICE S.A | E | N | 17/02/2023 |
8 | ENTEROGERMINA | SPORES DE BACILLUS CLAUSII POLYANTIBIO-RÉSISTANT | 4 milliards/5ml | SUSP BUV | B/10 | SANOFI-AVENTIS S.p.A | I | N | 20/02/2023 |
9 | ONCASPAR | PEGASPARGASE | 750 U/ML | PDRE PR SOL INJ | B/1 FL | SERVIER | E | N | 22/02/2023 |
10 | JARDIANCE | empagliflozine | 10 mg | comprimé | B/30 | Boehringer Ingelhei Allemagne | E | V | 23/02/2023 |
11 | JARDIANCE | empagliflozine | 25 mg | comprimé | B/30 | Boehringer Ingelhei Allemagne | E | V | 23/02/2023 |
12 | PROXIDA | Dexmedetomidine | 200 µG/2ml | SOL INJ PR PERF | B/1FL | HIKMA Pharmaceuticals | N | 02/03/2023 | |
13 | ISOSUPRA LIDOSE | ISOTRETINOINE | 8 Mg | Gélule | B/30 | SMB SA | I | N | 03/07/2023 |
14 | TARKA | TRANDOLAPRIL+VERAPAMIL | 180mg /2 mg | COMP LP | B/28 | ABBOTT GmbH & Co.KG | E | N | 03/07/2023 |
15 | TARKA FORTE | TRANDOLAPRIL+VERAPAMIL | 240 mg /4 mg | COMP LP | B/28 | ABBOTT GmbH & Co.KG | E | N | 03/07/2023 |
16 | XELJANZ XR | TOFACITINIB | 11 mg | COMP PEL LP | B/30 | Pfizer Inc USA | E | N | 05/08/2023 |
17 | SIMULECT | BASILIXIMAB | 20 mg | PDRE PR PREP INJ | B/1FL+S/5 ml | NOVARTIS PHARMA SCHWEIZ AG | V | T | 05/10/2023 |
* 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 | TRANXENE | CLORAZEPATE DIPOTASSIQUE | 20 MG | PDRE PR PREP INJ | SANOFI AVENTIS France | I | V | CS 29/12/2020 | |
2 | PENTASA | MESALAZINE | 1 g | SUPPO | B/28 | FERRING GmbH | E | N | 28/11/2022 |
3 | LOXEN | NICARDIPINE | 20 MG | COMP SECABLE | B/30 | CARDIXO | E | T | 13/12/2022 |
4 | ALPHAGAN | TARTRATE DE BRIMONIDE | 2MG/ML | COLLYRE | FL/ML | ABBVIE BV VLOG NETHERLAND | T | 22/12/2022 | |
5 | HEALER CREME | MAFENIDE ACETATE | 8.5% | CREME DERMIQUE | T/15 gr | BEIT JALA Pharmaceutical Co | C | N | 05/01/2023 |
6 | KALINOR - retard P | CHLORURE DE POTASSIUM | 600 mg | GELULLE | B/50 | DESMA GmbH | T | 05/01/2023 | |
7 | IMBRUVICA | IBRUTINIB | 560 mg | COM PEL | B/30 | Janssen-Cilag International N.V | E | N | 05/01/2023 |
8 | IMBRUVICA | IBRUTINIB | 420 mg | COM PEL | B/30 | Janssen-Cilag International N.V | E | N | 05/01/2023 |
9 | IMBRUVICA | IBRUTINIB | 280 mg | COM PEL | B/30 | Janssen-Cilag International N.V | E | N | 05/01/2023 |
10 | IMBRUVICA | IBRUTINIB | 140 mg | COM PEL | B/30 | Janssen-Cilag International N.V | E | N | 05/01/2023 |
11 | VENCLYXTO | VENETOCLAX | 10 mg | COM PEL | B/7 | ABBVIE DEUTSCHLAND GmbH & Co,KG | V | CS 10/01/2023 | |
12 | VENCLYXTO | VENETOCLAX | 50 mg | COM PEL | B/7 | ABBVIE DEUTSCHLAND GmbH & Co,KG | V | CS 10/01/2023 | |
13 | VENCLYXTO | VENETOCLAX | 100 mg | COM PEL | B/7 | ABBVIE DEUTSCHLAND GmbH & Co,KG | V | CS 10/01/2023 | |
14 | VENCLYXTO | VENETOCLAX | 100 mg | COM PEL | B/14 | ABBVIE DEUTSCHLAND GmbH & Co,KG | V | CS 10/01/2023 | |
15 | VENCLYXTO | VENETOCLAX | 100 mg | COM PEL | B/112 | ABBVIE DEUTSCHLAND GmbH & Co,KG | V | CS 10/01/2023 | |
16 | JAKAVI | RUXOLITINIB | 15 mg | COMPRIME | B/56 | NOVARTIS PHARMA SCHWEIZ AG | E | V | CS 10/01/2023 |
17 | JAKAVI | RUXOLITINIB | 20 mg | COMPRIME | B/56 | NOVARTIS PHARMA SCHWEIZ AG | E | V | CS 10/01/2023 |
18 | JAKAVI | RUXOLITINIB | 5 mg | COMPRIME | B/56 | NOVARTIS PHARMA SCHWEIZ AG | E | V | CS 10/01/2023 |
19 | INTRATECT | IMMUNOGLOBULINE HUMAINE POLYVALENTE | 10G/200ML | SOL INJ PR PRF | FL/200 ML | BIOTEST PHARMA GMBH | E | V | CS 10/01/2023 |
20 | INTRATECT | IMMUNOGLOBULINE HUMAINE POLYVALENTE | 5G/50ML | SOL INJ PR PRF | FL/50 ML | BIOTEST PHARMA GMBH | E | V | CS 10/01/2023 |
21 | INTRATECT | 10G/10ML | SOL INJ PR PRF | FL/100 ML | BIOTEST PHARMA GMBH | E | V | CS 10/01/2023 | |
22 | SINGULAIR | MONTELUKAST | 4 MG | GRANULES | B/28 | ORGANON BV | T | 18/01/2023 | |
23 | Pemzek | Candesartan | 8 mg | comprimé | B/28 | ASTRA ZENECA SUISSE | E | T | CS 31/01/2023 |
24 | Pemzek | Candesartan | 16 mg | comprimé | B/28 | ASTRA ZENECA SUISSE | E | T | CS 31/01/2023 |
25 | Pemzek PLUS | Candesartan | 8 mg/12.5 MG | comprimé | B/28 | ASTRA ZENECA SUISSE | E | V | CS 31/01/2023 |
26 | Pemzek PLUS | Candesartan+Hydrochlorothiazide | 16 mg/12.5 MG | comprimé | B/28 | ASTRA ZENECA SUISSE | E | V | CS 31/01/2023 |
27 | Jardiance | empagliflozine | 10 mg | comprimé | B/30 | Boehringer Ingelhei Allemagne | E | V | CS 31/01/2023 |
28 | Jardiance | empagliflozine | 25 mg | comprimé | B/30 | Boehringer Ingelhei Allemagne | E | V | CS 31/01/2023 |
29 | ROPIVACAINE KABI | ROPIVACAINE | 5 mg/ml, | solution injectable en ampoule. | B/5 | FRESINUS KABI | E | V | CS 31/01/2023 |
30 | ROPIVACAINE KABI | ROPIVACAINE | 7,5 mg/ml, | solution injectable en ampoule. | B/5 | FRESINUS KABI | E | V | CS 31/01/2023 |
31 | HALAVEN | MESILATE D'ERIBULINE | 0.44 mg/ml | SOL INJ | Fl/2ml | Eisai Europe Limited | V | N | 08/02/2023 |
32 | PYLERA | BISMUTH +METRONIDAZOLE+TETRACYCLINE | 140mg/125mg/125mg | GELULLE | B/120 Gélule | Allergan Sales LLC | E | T | 08/02/2023 |
33 | ENSPRYNG | SATRALIZUMAB | 120 mg/1 ml | SERINGUE | B/1 | Roche Pharma (Schweiz) AG | N | 14/02/2023 | |
34 | ZINNAT | CEFUROXIME | 125 MG | COMP PEL | B/14 | Sandoz Pharmaceuticals d.d | T | 04/10/2023 | |
35 | ZINNAT | CEFUROXIME | 125 MG | FLACON | F/70 ML | Sandoz Pharmaceuticals d.d | T | 04/10/2023 | |
36 | ELPIDA | DASATINIB | 20 mg | COMPRIME | B/60 | HIKMA Pharmaceuticals | N | 04/11/2023 | |
37 | ELPIDA | DASATINIB | 50 mg | COMPRIME | B/60 | HIKMA Pharmaceuticals | N | 04/11/2023 | |
38 | ELPIDA | DASATINIB | 140 mg | COMPRIME | B/60 | HIKMA Pharmaceuticals | N | 04/11/2023 | |
39 | ELPIDA | DASATINIB | 70 mg | COMPRIME | B/60 | HIKMA Pharmaceuticals | N | 04/11/2023 | |
40 | RUCORON | ROCURONIUM BROMURE | 50 MG/ 5ML | SOL INJ | B/10 | HIKMA Pharmaceuticals | N | 04/11/2023 | |
41 | PEMITRA | PEMETREXED | 500 mg | PDRE PR PREP INJ | B/1 | HIKMA Pharmaceuticals | N | 04/11/2023 | |
42 | ERIVEDGE | VISMODEGIB | 150 mg | GELULLE | B/28 | Roche Pharma (Schweiz) AG | N | 04/11/2023 | |
43 | ERLEADA | APALUTAMIDE | 60 mg | COMP PEL | B/112 | Janssen-Cilag International N.V | N | 04/11/2023 | |
44 | ZINNAT | CEFUROXIME | 250 MG | COMP PEL | B/14 | Sandoz Pharmaceuticals d.d | T | 20/4/2023 | |
45 | FORADIL | FORMOTEROL | 12 MCG | GELULLE | B/60 | Sandoz Pharmaceuticals AG | T | 19/04/2023 | |
46 | XANAX RETARD | ALPRAZOLAM | 0,5 MG | COMP LP | B/30 | UPJOHN SRL | I | V | CS 10/05/2023 |
47 | XANAX RETARD | ALPRAZOLAM | 1 MG | COMP LP | B/30 | UPJOHN SRL | I | V | CS 10/05/2023 |
48 | XANAX | ALPRAZOLAM | 0,75 MG | GTTES BUVABLES | FL/20 ML | UPJOHN SRL | I | V | CS 10/05/2023 |
49 | TEVER | CARBAMAZEPINE | 200 MG | COMPRIME | B/50 | MEDOCHEMIE LTD | V | V | CS 10/05/2023 |
50 | RITALIN | METHYLPHENIDATE | 10 MG | COMP SECABLE | B/30 | NOVARTIS PHARMA SCHWEIZ AG | E | V | CS 10/05/2023 |