Dossiers d'AMM à étudier par le Comité Technique des Spécialités Pharmaceutiques du 14/03/2018.
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 | Présentation | Titulaire |
1 | NEACREST | ROSUVASTATINE | 40 mg | Comprimé pelliculé | B/30 | NEAPOLIS PHARMA |
2 | NEACREST | ROSUVASTATINE | 40 mg | Comprimé pelliculé | B/90 | NEAPOLIS PHARMA |
3 | DEPROL | CABERGOLINE | 0.5 MG | Comprimé | FL/2 | ADWYA |
4 | EOS EASY FLOW | FUMARATE DE FORMOTEROL + BUDESONIDE | 12 µg/400 µg | Pdre pour inhalation buccale | B(/60+60) | OPALIA PHARMA |
5 | Z ZOLE | ALBENDAZOLE | 400 mg | Comprimé | B/4 | OPALIA PHARMA |
6 | N-FESS | MONTELUKAST | 5 mg | Cp à croquer | B/30 | OPALIA PHARMA |
7 | N-FESS | MONTELUKAST | 10 mg | Cp à croquer | B/30 | OPALIA PHARMA |
8 | FLIKA | FLECAINIDE | 100 mg | Cp | B/30 | TAHA PHARMA |
9 | CADOTREX100 | RECECADOTRIL | 100 mg | Gélule | B/20 | TAHA PHARMA |
* Produits à évaluer pour la première fois au Comité Technique
Médicament | DCI | Dosage | Forme | Présentation | Laboratoire | |
1 | URPEX | ACICLOVIR | 5% | Creme dermique | T/5 GR | GALPHARMA |
2 | DOPIDIUM | DOMPERIDONE | 10 mg | Comprimé pelliculé | B/40 | TERIAK |
3 | STAFLOX | FLUCLOXACILLINE | 500 mg | Gélule | B/12 | ADWYA |
4 | STAFLOX | FLUCLOXACILLINE | 500 mg | Gélule | B/24 | ADWYA |
5 | HYALVI 20 | HYALURONATE DE SODIUM | 20 mg/2ml | Solution injectable | FL/2 ML | DORCAS |
6 | ACTIPP | ESOMEPRAZOLE | 40 mg | Gélule gastrorésistante | B/8 | ACT PHARMA |
7 | RUGDAL | ESOMEPRAZOLE | 20 mg | Gélule gastrorésistante | Flacon/16 | GALPHARMA |
8 | SIVASTYN | SIMVASTATINE | 20 mg | Comprimé pelliculé sécable | B/30 | TAHA PHARMA |
9 | TARDYFERON | FER | 80 mg | Comprimé enrobé | B/30 | PIERRE FABRE MEDICAMENT PRODUCTION TUNISIE |
10 | TARDYFERON | FER | 80 mg | Comprimé enrobé | B/100 | PIERRE FABRE MEDICAMENT PRODUCTION TUNISIE |
Spécialités Pharmaceutiques importées :
* Produits déjà évalués lors des derniers Comités Techniques
N° | Médicament | DCI | Dosage | Forme Pharmaceutique | Présentation | TITULAIRE |
1 | MYDRIASERT | TROPICAMIDE+PHENYLEPHRINE | 0,28mg/ 5,4mg | IMPLANT | B/20 | THEA |
2 | TYSABRI | NATILUZUMAB | 300mg | SOLUTION INJECTABLE | B/1FL/15ml | BIOGEN IDEC LTD |
3 | TECFIDERA | DIMETHYLFUMARATE | 120mg | GELULE | B/14 | BIOGEN IDEC LTD |
4 | TECFIDERA | DIMETHYLFUMARATE | 240mg | GELULE | B/56 | BIOGEN IDEC LTD |
5 | GARDASIL | QUADRIVALENT HUMAN PAPILLOMAVIRUS | SUSPENSION INJECTABLE | B/1FL/0,5ml | MERCK &CO | |
6 | HYALOSILVER | HYALURONATE DE SODIUM | 0,002 | PDRE USAGE EXTERNE | FL/50ml | FIDIA PHARMACEUTICAL |
7 | PICOPREP | PICOSULFATE DE SODIUM+OXYDE DE MG | SACHETS | B/2 | FERRING SAS | |
8 | DIVIDO | DICLOFENAC SODIQUE | 75 mg | GELULE LP | B/20 | TABUK |
9 | TOPOTECAN KABI | TOPOTECAN | 1mg/ml | PDRE PREP INJ | B/ 1 Flacon | FRESENIUS KABI ONCOLOGY PLC |
10 | ZALTRAP | AFLIBERCEPT | 25mg/ml | SOLUTION INJECTABLE | Fl/4ml | SANOFI AVENTIS |
11 | ZALTRAP | AFLIBERCEPT | 25mg/ml | SOLUTION INJECTABLE | Fl/4ml | SANOFI AVENTIS |
12 | LOTEVAN | AMLODIPINE+VALSARTAN | 5/160mg | COMPRIME | B/30 | TABUK Pharmaceutical |
13 | LOTEVAN | AMLODIPINE+VALSARTAN | 10/160mg | COMPRIME | B/30 | TABUK Pharmaceutical |
14 | LATAZ 0,005% | LATANOPROST | 50 mcg/ml | Collyre | FL/2.5 ML | RAFARM SA |
15 | LATAZ 0CO | LATANOPROST+TIMOLOL | Collyre | FL/2.5 ML | RAFARM SA | |
16 | OPTODROP-CO | DORZOLAMIDE +TIMOLOL | Collyre | FL/5 ML | RAFARM SA | |
17 | AUBAGIO | TERIFLUNOMIDE | COMPRIME PELLICULE | B/28 | SANOFI AVENTIS | |
18 | FRAGOR | DELAPRIDE+MANIDIPINE | 30mg+10mg | COMPRIME | B/28 | CHIESI Italie |
19 | OFEV | NINTEDANIB | 100mg | CAPSULE MOLLE | B/60 | BOEHRINGER |
20 | OFEV | NINTEDANIB | 150mg | CAPSULE MOLLE | B/60 | BOEHRINGER |
21 | DIANEAL PD4 | GLUCOSE+ELECTROLYTES | 3,86 | SOL DIALYSE PERI | POCHE 2L | BAXTER UK |
22 | DIANEAL PD4 | GLUCOSE+ELECTROLYTES | 2,27 | SOL DIALYSE PERI | POCHE 2L | BAXTER UK |
23 | DIANEAL PD4 | GLUCOSE+ELECTROLYTES | 1,36 | SOL DIALYSE PERI | POCHE 5L | BAXTER UK |
24 | DIANEAL PD4 | GLUCOSE+ELECTROLYTES | 1,36 | SOL DIALYSE PERI | POCHE 2L | BAXTER UK |
25 | DIANEAL PD4 | GLUCOSE+ELECTROLYTES | 2,27 | SOL DIALYSE PERI | POCHE 5L | BAXTER UK |
26 | BICALUTAMIDE ACCORD | BICALUTAMIDE | 50MG | COMPRIME PELLICULE | B/28 | ACCORD HAELTHCARE |
27 | OPDIVO | NIVOLUMAB | 40 mg/4 ml | SOL INJECTABLE | B/1FL/4ml | BMS |
28 | OPDIVO | NIVOLUMAB | 100 mg/10 ml | SOL INJECTABLE | B/1FL/10ml | BMS |
29 | EFIENT | PRASUGREL | 5MG | COMPRIME | B/28 | DAIICHI SANKYO EUROPE |
30 | EFIENT | PRASUGREL | 10MG | COMPRIME | B/28 | DAIICHI SANKYO EUROPE |
31 | VIGAMOX | MOXIFLOXACINE | 5MG/ML | COLLYRE | FL/5ML | ALCON |
32 | ORFADIN | NITISINONE | 20MG | GELLULE | FL/60 | SOBI |
33 | ORFADIN | NITISINONE | 4MG/ML | SUSP ORALE | FL/90ML | SOBI |
34 | KIVEXA | ABACAVIR/LAMIVUDINE | 600/300MG | COMPRIME PELLICULE | B/30 | VIIV HAETHCARE |
35 | TRESIBA FLEXTACH | INSULINE DEGLUDEC | 100 U/ ML | stylos préremplis de 3 ml | B/3 | NOVO NORDISK A/S |
36 | TRESIBA FLEXTACH | INSULINE DEGLUDEC | 200 U/ ML | stylos préremplis de 3 ml | B/3 | NOVO NORDISK A/S |
37 | SURVANTA | BERACTANT | 100mg/4ml | susp,intrachéale | FL/8ML | ABBVIE CORPORATION |
38 | SURVANTA | BERACTANT | 200mg/8ml | susp,intrachéale | FL/8ML | ABBVIE CORPORATION |
* Produits à évaluer pour la première fois au Comité Technique
N° | Médicament | DCI | Dosage | Forme Pharmaceutique | Présentation | TITULAIRE |
1 | PERJETA | PERTUZUMAB | 420MG/14ML | SOL INJ PERFUSION | B/1FL | ROCHE PHARMA |
2 | LAMICTAL | LAMOTRIGINE | 2MG | COMPRIME A CROQUER | B/1FL/30 | GSK France |
3 | ZYTIGA | ABIRATERONE | 250MG | COMPRIME | B/120 | JANSSEN-CILAG |
4 | ERBITUX | CETUXIMAB | 500MG/ML | SLO PERF | FL/100 ML | MERCK |
5 | ERBITUX | CETUXIMAB | 5MG/ML | SOL INJ PERFUSION | B/1FL/25ML | MERCK |
6 | SOMATULINE LP | LANREOTIDE | 60 MG | SOL INJ | B/1 SERINGUE | IPSEN PHARMA |
7 | SOMATULINE LP | LANREOTIDE | 90 MG | SOL INJ | B/1 SERINGUE | IPSEN PHARMA |
8 | SOMATULINE LP | LANREOTIDE | 120 MG | SOL INJ | B/1 SERINGUE | IPSEN PHARMA |
9 | VECTIBIX | PANITUMUMAB | 100MG/5ML | SOL PERF | B/1FL/20ML | AMGEN EUROPE BV |
10 | VECTIBIX | PANITUMUMAB | 400MG/20ML | SOL PERF | B/1FL/20ML | AMGEN EUROPE BV |
11 | JEVTANA | CABAZITAXEL | 60MG | SOL INJ PERFUSION | B/1FL+1FL SLVT | SANOFI AVENTIS France |
12 | CAMPTO | IRINOTECAN | 20MG/ML | SOL INJ PERFUSION | B/1FL/2ML | PFIZER HOLDING |
13 | CAMPTO | IRINOTECAN | 20MG/ML | SOL INJ PERFUSION | B/1FL/5ML | PFIZER HOLDING |
14 | CAMPTO | IRINOTECAN | 20MG/ML | SOL INJ PERFUSION | B/1FL/15ML | PFIZER HOLDING |
15 | VARGATEF | NINTEDANIB | 100MG | CAPSULES MOLLES | B/120 | BOEHRINGER |
16 | SUTENT | SUNITINIB | 12,5MG | GELULES | B/28 | PZIFER LTD |
17 | SUTENT | SUNITINIB | 25MG | GELULES | B/28 | PZIFER LTD |
18 | SUTENT | SUNITINIB | 50MG | GELULES | B/28 | PZIFER LTD |
19 | DECAPEPTYL LP | TRIPTORELINE | 3MG | PDRE PREP INJ | B/1FL+SLVT | IPSEN PHRAMA |
20 | AVASTIN | BEVACIZUMAB | 100MG | SOL INJ | B/1FL/16ML | ROCHE PHARMA |
21 | AVASTIN | BEVACIZUMAB | 400MG | SOL INJ | B/1FL/16ML | ROCHE PHARMA |
22 | AFINITOR | EVEROLIMUS | 5MG | COMPRIME | B/30 | NOVARTIS |
23 | AFINITOR | EVEROLIMUS | 10MG | COMPRIME | B/30 | NOVARTIS |
24 | KEVESEY | LEVITIRACETAM | 5MG/ML | SOL,INJ | B/10POCHES | STRAGEN |
25 | KEVESEY | LEVITIRACETAM | 10MG/ML | SOL,INJ | B/10POCHES | STRAGEN |
26 | KEVESEY | LEVITIRACETAM | 15MG/ML | SOL,INJ | B/10POCHES | STRAGEN |
27 | XTANDI | ENZALUTAMIDE | 40MG | CAPSULES MOLLES | B/112 | ASTELLAS PHARMA |
28 | MONTELUKAST MYLAN | MONTELUKAST | 5MG | COMPRIME A CROQUER | B/28 | MYLAN SAS |
29 | ATROPINE SULFATE AGUETTANT | ATROPINE SULFATE | 0,5MG | SOL INJ | B/10/5ML | AGUETTANT |
30 | ATACAND | CANDESERTAN CILEXETIL | 4MG | COMPRIME SECABLE | B/30 | ASTRA ZENECA |
31 | ATACAND | CANDESERTAN CILEXETIL | 8MG | COMPRIME SECABLE | B/30 | ASTRA ZENECA |
32 | ATACAND | CANDESERTAN CILEXETIL | 16MG | COMPRIME SECABLE | B/30 | ASTRA ZENECA |
33 | DOBUTAMINE MYLAN | DOBUTAMINE | 250MG/20ML | SOL INJ | B/10/20ML | MYLAN SAS |
34 | BRONCHODUAL | FENOTEROL+IPRATROPIUM | 50µG/20µG | SOL INHAL | FL/200DOSES | BOEHRINGER INGELHEIM |
35 | STELARA | USTEKINUMAB | 45MG/0,5ML | SOL INJ | B/1FL | JANSSEN-CILAG |
36 | STELARA | USTEKINUMAB | 45MG/0,5ML | SOL INJ | B/1 SERINGUE PRE-REMPLIE | JANSSEN-CILAG |
37 | STELARA | USTEKINUMAB | 90MG/ML | SOL INJ | B/1 SERINGUE PRE-REMPLIE | JANSSEN-CILAG |
38 | HYALOSILVER | HYALURONATE DE SODIUM | 0,002 | PDRE USAGE EXTERNE | FL/125ML | FIDIA PHARMACEUTICAL |
39 | ALDURAZYME | LARONIDASE | 100U/ML | CONCENTRE STERILE | B/1FL | GENZYME |
40 | EPIDUO | ADAPALENE+PEROXYDE DE BENZOYLE | 0,1%+2,5% | GEL | FL/30GR | GALDERMA |
41 | MEROPENEM KABI | MEROPENEME TRIHYDRATE | 1GR | SOL,INJ | B/10FL/20ML | FREISINIUS KABI |
42 | ZYTIGA | ACETATE ABIRATERONE | 500MG | COMPRIME PELLICULE | B/56 | JANSSEN CILAG |