Dossiers d'AMM à étudier par le Comité Technique des Spécialités Pharmaceutiques du 15/01/2020.
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 | OFLODIS | Ofloxacine | 200 MG | comprimé pelliculé sécable | B/20 | GALPHARMA |
E | V | 25/12/2019 |
2 | RAXIDONE SAIPH |
Rispéridone | 4 mg | cp pell sécable | B/30 | SAIPH | E | N | 13/01/2020 |
* 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 | RETA | VALSARTAN | 80 MG | Comprimé pelliculé sécable | B/90 | LES LABORATOIRES MEDIS | E | N | - - |
2 | RETA | VALSARTAN | 160 MG | Comprimé pelliculé sécable | B/90 | LES LABORATOIRES MEDIS | E | N | - - |
3 | TERBUTALINE SIMED | TERBUTALINE | 1.5 MG/5ML | Sirop | FL/300ML | SIMED | E | V | 06/01/2020 |
4 | THEOPHYLLINE LP | THEOPHYLLINE | 100 mg | Gélule à libération prolongée | B/600 | SIPHAT | E | V | 06/01/2020 |
5 | BRONCHOFYLINE LP | THEOPHYLLINE | 200 mg | Comprimé à libération prolongé | B/30 | DAR-ESSAYDALI. | E | V | 06/01/2020 |
6 | BRONCHOFYLINE LP | THEOPHYLLINE | 200 mg | Comprimé à libération prolongé | B/345 | DAR-ESSAYDALI. | E | V | 06/01/2020 |
7 | BRONCHOFYLINE LP | THEOPHYLLINE | 300 mg | Comprimé à libération prolongé | B/30 | DAR-ESSAYDALI. | E | V | 06/01/2020 |
8 | BRONCHOFYLINE LP | THEOPHYLLINE | 300 mg | Comprimé à libération prolongé | B/150 | DAR-ESSAYDALI. | E | V | 06/01/2020 |
9 | BROMHEXINE | BROMHEXINE | 4 MG | Comprimé pelliculé | B/40 | SIPHAT | I | V | 06/01/2020 |
10 | BROMHEXINE | BROMHEXINE | 4 MG | Comprimé pelliculé | B/500 | SIPHAT | C | V | 06/01/2020 |
11 | BROMHEXINE | BROMHEXINE | 4 mg | Comprimé pelliculé | B/1000 | SIPHAT | C | V | 06/01/2020 |
12 | DRILL TOUX SECHE DEXTROMETORPH | DEXTROMETHORPHANE | 0.3% | Sirop | FL/150 ML | SIMED | C | V | 06/01/2020 |
13 | VASCOR | SIMVASTATINE | 10 mg | Comprime enrobe secable | B/30 | ADWYA | E | V | 26/11/2019 |
14 | KARDEGIC | ACETYLSALICYLATE DE LYSINE | 160 mg | Poudre pour solution orale | B/20 sachets | SANOFI AVENTIS PHARMA TUNISIE | E | V | 06/01/2020 |
15 | KARDEGIC | ACETYLSALICYLATE DE LYSINE | 160 mg | Poudre pour solution orale | B/30 sachets | SANOFI AVENTIS PHARMA TUNISIE | E | V | 06/01/2020 |
16 | ZARTAN | LOSARTAN | 50 mg | Comprimé pelliculé sécable | B/30 | ADWYA | E | V | 06/01/2020 |
17 | ZARTAN | LOSARTAN | 50 mg | Comprimé pelliculé sécable | B/90 | ADWYA | E | V | 06/01/2020 |
18 | ZARTAN FORT | LOSARTAN | 100 mg | Comprimé pelliculé sécable | B/30 | ADWYA | E | V | 06/01/2020 |
19 | ZARTAN FORT | LOSARTAN | 100 mg | Comprimé pelliculé sécable | B/90 | ADWYA | E | V | 06/01/2020 |
20 | PLAVIX | CLOPIDOGREL | 75 mg | Comprimé pelliculé | B/28 | SANOFI AVENTIS PHARMA TUNISIE | E | V | 06/01/2020 |
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 | XTANDI | ENZALUTAMIDE | 40 MG | CAPSULE MOLLE | B/112 | ASTELLAS | E | N | 15/07/2019 |
2 | BETMIGA | MIRABEGRON | 50MG | COMP LIB PRO | B/30 | ASTRELLAS | E | N | 16/07/2019 |
3 | ACIDE ZOLEDRONIQUE | ACIDE ZOLÉDRONIQUE | 4 MG/5 ML | FLACON | B/ 1FL/ 5ml | MYLAN S.A.S | E | N | 22/07/2019 |
4 | ZYTIGA | ACETATE D'ABIRATERONE | 500 MG | CP PELLICULE | B/56 | JANSEN-CILAG | V | N | 29/07/2019 |
5 | ZYTIGA | ABIRATERONE | 250 mg | COMP | B/120 | JANSSEN-CILAG | V | V | 29/07/2019 |
6 | XALKORI | CRIZOTINIB | 200 mg | GELULE | FL/60 | PFIZER | V | N | 29/07/2019 |
7 | XALKORI | CRIZOTINIB | 250 mg | GELULE | FL/60 | PFIZER | V | N | 29/07/2019 |
8 | IBRANCE | PALBOCICLIB | 125 MG | GELULE | FL/21 | PFIZER | E | N | 29/07/2019 |
9 | IBRANCE | PALBOCICLIB | 100 MG | GELULE | FL/21 | PFIZER | E | N | 29/07/2019 |
10 | IBRANCE | PALBOCICLIB | 75 MG | GELULE | FL/21 | PFIZER | E | N | 29/07/2019 |
11 | TEGOZOL | TÉMOZOLOMIDE | 100 mg | GELLULE | B/5 | HIKMA Pharmaceuticals | E | N | 30/07/2019 |
12 | TEGOZOL | TÉMOZOLOMIDE | 20 mg | GELLULE | B/5 | HIKMA Pharmaceuticals | E | N | 30/07/2019 |
13 | TEGOZOL | TÉMOZOLOMIDE | 5 mg | GELLULE | B/5 | HIKMA Pharmaceuticals | E | N | 30/07/2019 |
14 | RILAMIG | FROVATRIPTAN | 2.5mg | COMP PEL | B/2 | Menarini International Operation Luxembourg S.A | E | N | 31/07/2019 |
15 | DROPERIDOL AGUETTANT | DROPERIDOL | 1.25 mg/ml | SOL INJ | B/10 AMP | AGUETTANT | E | N | 07/08/2019 |
16 | CLARISCAN | ACIDE GADOTERIQUE | 0,05 mmol/ml | Sol inj | B/10fl/10ml | GE Healthcare Norvège | E | N | 03/09/2019 |
17 | CLARISCAN | ACIDE GADOTERIQUE | 0,05 mmol/ml | Sol inj | B/10fl/15ml | GE Healthcare Norvège | E | N | 03/09/2019 |
18 | CLARISCAN | ACIDE GADOTERIQUE | 0,05 mmol/ml | Sol inj | B/10fl/20ml | GE Healthcare Norvège | E | N | 03/09/2019 |
19 | NUTRIFLEX LIPID PERI | AA + G + LIP + ELECTROLYTES | 1875 ml | EMULSION INJ | POCHE/ 1875 ml | B.BRAUN Melsungen AG | V | N | 13/09/2019 |
20 | NUTRIFLEX LIPID PERI | AA + G + LIP + ELECTROLYTES | 2500 ML | EMULSION INJ | POCHE/ 2500 ML | B.BRAUN Melsungen AG | V | N | 13/09/2019 |
21 | NUTRIFLEX LIPID PERI | AA + G + LIP + ELECTROLYTES | 1250 ML | EMULSION INJ | POCHE/ 1250ML | B.BRAUN Melsungen AG | V | N | 13/09/2019 |
22 | NUTRIFLEX LIPID PLUS | AA + G + LIP + ELECTROLYTES | 2500 ML | EMULSION INJ | POCHE/ 2500 ML | B.BRAUN Melsungen AG | V | N | 13/09/2019 |
23 | NUTRIFLEX LIPID PLUS | AA + G + LIP + ELECTROLYTES | 1875 ML | EMULSION INJ | POCHE/ 1875 ML | B.BRAUN Melsungen AG | V | N | 13/09/2019 |
24 | NUTRIFLEX LIPID PLUS | AA + G + LIP + ELECTROLYTES | 1250 ML | EMULSION INJ | POCHE/ 1250ML | B.BRAUN Melsungen AG | V | N | 13/09/2019 |
25 | STODALINE SANS SUCRE | PRODUITS HOMEOPATHIQUES | SIROP | FL/200 ML | BOIRON | C | N | 19/09/2019 | |
26 | SUXAMETHONIUM CHLORID VUAB | SUXAMETHONIUM | 100 mg | PDRE P SUSP INJ | B/1FL | VUAB PHARMA AS | V | N | 20/09/2019 |
27 | GAZYVARO | OBINUTUZUMAB | 1000MG/40ML | SOL INJ | B/1FL/40ML | ROCHE PHARMA (SCHWEIZ) LTD SUISSE | E | N | 25/09/2019 |
28 | LOTEMAX | LOTEPREDNOL | 0.5% | GEL OPHTALMIQUE | FL /10ml | BAUSCH AND LOMB | E | N | 29/09/2019 |
29 | RELVAR ELLIPTA | FUROATE DE FLUTICASONE/VILANTEROL | 92/22µg | PDRE PR INHALATION BUCCALE | B/1 INH DE 30 DOSES | GALAXO GROUP LTD | E | V | 30/09/2019 |
30 | RELVAR ELLIPTA | FUROATE DE FLUTICASONE/VILANTEROL | 184/22µg | PDRE PR INHALATION BUCCALE | B/1 INH DE 30 DOSES | GALAXO GROUP LTD | E | V | 30/09/2019 |
31 | STELARA | USTEKINUMAB | 45 mg/0.5ml | SOL INJ | B/1FL/0.5ml | Janssen-Cilag International N.V | E | N | 01/10/2019 |
32 | STELARA | USTEKINUMAB | 45 mg/0.5ml | SOL INJ | B/1seringue pré-remplie/0.5ml | Janssen-Cilag International N.V | E | N | 01/10/2019 |
33 | STELARA | USTEKINUMAB | 130mg/26ml | SOL INJ PR PERF | B/1FL/30ML | Janssen-Cilag International N.V | E | N | 01/10/2019 |
34 | STELARA | USTEKINUMAB | 90mg/ml | SOL INJ | B/1Seringue pré-remplie/1ml | Janssen-Cilag International N.V | E | N | 01/10/2019 |
35 | PMS-RISEDRONATE | RISEDRONATE | 35 mg | COMP PEL | B/4 | PHARMASCIENCE INC CANADA | E | N | 02/10/2019 |
36 | PROLUTEX | PROGESTERONE | 25mg | SOL INJ | B/7Flacons | IBSA Institut Biochimique SA | E | N | 02/10/2019 |
37 | AKYNZEO | NETUPITANT+PALONOSETRON | 300mg/ 0.5mg | GELLULE | B/1 | HELSINN BIREX Pharmaceuticals Ltd | E | N | 07/10/2019 |
38 | TARGINACT | OXYCODONE+ NALOXONE | 40mg/20mg | COMP | B/56 | Napp Pharmaceuticals Limited | V | N | 08/10/2019 |
39 | TARGINACT | OXYCODONE+ NALOXONE | 20mg/10mg | COMP | B/56 | Napp Pharmaceuticals Limited | V | N | 08/10/2019 |
40 | TARGINACT | OXYCODONE+ NALOXONE | 10mg/5mg | COMP | B/56 | Napp Pharmaceuticals Limited | V | N | 08/10/2019 |
41 | ALDARA | IMIQUIMOD | 5% | CREME DERMIQUE | B/12 Sachets Unidoses/250 mg | MEDA AB | E | N | 09/10/2019 |
42 | RANEXA | RANOLAZINE | 500 mg | COMP | B/60 | Menarini International Operation Luxembourg S.A | E | N | 23/10/2019 |
43 | RANEXA | RANOLAZINE | 750 mg | COMP | B/60 | Menarini International Operation Luxembourg S.A | E | N | 23/10/2019 |
44 | MYDRANE | TROPICAMIDE+ CHLORHYDRATE DE PHENYLEPHRINE+ CHLORHYDRATE DE | 0.2mg/ml+ 3.1mg/ml+ 10mg/ml | AMPOULE | B/20 Ampoules de 1 ml + 20 aiguilles | THEA | I | N | 24/10/2019 |
45 | HUMIRA | ADALIMUMAB | 40 mg | SERINGUE | B/2 seringues/0.4 ml | ABBVIE DEUTSCHLAND Gmbh and Co.KG | E | N | 29/10/2019 |
46 | LIPANTHYL | FENOFIBRATE | 145 mg | COMP PEL | B/30 | MYLAN MEDICAL SAS | E | N | 29/10/2019 |
47 | INLYTA | AXITINIB | 5 mg | COMP PEL | B/28 | PFIZER AG | V | N | 20/11/2019 |
48 | INLYTA | AXITINIB | 5 mg | COMP PEL | B/56 | PFIZER AG | V | N | 20/11/2019 |
49 | INLYTA | AXITINIB | 1 mg | COMP PEL | B/56 | PFIZER AG | V | N | 20/11/2019 |
50 | INLYTA | AXITINIB | 1 mg | COMP PEL | B/28 | PFIZER AG | V | N | 20/11/2019 |
51 | EYLEA | AFLIBERCEPT | 40 mg/ml | SOL INJ | FL/ 100 ml | BAYER AG Leverkusen | N | 30/12/2019 |
* 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 | TEMOZOLOMIDE ACCORD | TÉMOZOLOMIDE | 5 mg | GELULE | B/5 | ACCORD HEALTHCARE LTD | E | N | 01/11/2019 |
2 | TEMOZOLOMIDE ACCORD | TÉMOZOLOMIDE | 250 mg | GELULE | B/5 | ACCORD HEALTHCARE LTD | E | N | 01/11/2019 |
3 | TEMOZOLOMIDE ACCORD | TÉMOZOLOMIDE | 20 mg | GELULE | B/5 | ACCORD HEALTHCARE LTD | E | N | 01/11/2019 |
4 | TEMOZOLOMIDE ACCORD | TÉMOZOLOMIDE | 100 mg | GELULE | B/5 | ACCORD HEALTHCARE LTD | E | N | 01/11/2019 |