Dossiers d'AMM à étudier par le Comité Technique des Spécialités Pharmaceutiques du 04/04/2018.
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° | DCI | Médicament | Dosage | Forme | Présentation | Titulaire |
1 | CISATRACURIUM | CUREX 10 | 2 mg/ml | Solution injectable | B/5 AMP/5 ML | DORCAS |
2 | PARACETAMOL+CAFEINE | ADOLINE EXTRA | 500 mg/65 mg | Comprimé pelliculé | B/20 | ALLIANCE PHARMA |
3 | PARACETAMOL+CAFEINE | ADOL EXTRA | 500 mg/65 mg | Comprimé pelliculé | B/20 | SAIPH |
4 | RACECADOTRIL | DIAREN | 10 mg | Poudre pour solution orale | B/30 sachets | PHARMAGHREB |
5 | GLIMEPIRIDE | IRYS | 6mg | Cp pelliculés sécables | B/30 | MEDIS |
6 | SPIRONOLACTONE | NORACTONE | 50 mg | Cp pelliculés sécables | B/30 | SAIPH |
7 | VALSARTAN+HYDROCHLOROTHIAZIDE | BIVAL | 320 mg/25 mg | Comprimé pelliculé | B/28 | PHILADELPHIA PHARMA |
8 | METFORMINE | STAGID | 700 mg | Comprimé sécable | B/30 | SAIPH |
9 | ALENDRONATE DE SODUIM+ Cholécalciferol | FOSALEN D3 | 70 mg/5600 UI | Comprimé | B/12 | TERIAK |
* Produits à évaluer pour la première fois au Comité Technique
N° | DCI | Médicament | Dosage | Forme | Présentation | Titulaire |
1 | AMLODIPINE+VALSARTAN+HYDROCHLOROTHIAZIDE | DUOFOR PLUS | 5mg/160mg/12.5 mg | Comprimé pelliculé | B/30 | PHILADELPHIA PHARMA |
2 | AMLODIPINE+VALSARTAN+HYDROCHLOROTHIAZIDE | DUOFOR PLUS | 10 mg/160mg/25mg | Comprimé pelliculé | B/30 | PHILADELPHIA PHARMA |
3 | AMLODIPINE+VALSARTAN+HYDROCHLOROTHIAZIDE | DUOFOR PLUS | 10 mg/160mg/12.5mg | Comprimé pelliculé | B/30 | PHILADELPHIA PHARMA |
4 | AMLODIPINE+VALSARTAN+HYDROCHLOROTHIAZIDE | DUOFOR PLUS | 5mg/160mg/25 mg | Comprimé pelliculé | B/30 | PHILADELPHIA PHARMA |
5 | MOXONIDINE | MOXONYL | 0.2 mg | Comprimé pelliculé | B/30 | TAHA PHARMA |
6 | MOXONIDINE | MOXONYL | 0.4 mg | Comprimé pelliculé | B/30 | TAHA PHARMA |
7 | IBUPROFEN+PSEUDOEPHEDRINE | IBURHUME | 200mg/30mg | Comprimé pelliculé | B/20 | PHARMACARE |
8 | IBUPROFEN+PSEUDOEPHEDRINE | IBURHUME FORT | 400mg/60mg | Comprimé pelliculé | B/10 | PHARMACARE |
9 | DEXTROMETHORPHANE | RHUVEX ENFANTS TOUX SECHE | 0.1% | Sirop | B/1FL/150ML | TERIAK |
10 | DEXTROMETHORPHANE | RHUVEX ADULTE TOUX SECHE | 0.3% | Sirop | B/1FL/150ML | TERIAK |
11 | ACIDE FUSIDIQUE | FUSIDAL | 2% | Creme dermique | T/15 GR | GALPHARMA |
12 | SILDENAFIL | ANTAR | 50 mg | Comprimé pelliculé | B/8 | GALPHARMA |
13 | SILDENAFIL | ANTAR | 100 mg | Comprimé pelliculé | B/8 | GALPHARMA |
14 | PREGABALINE | NERVICA | 75 mg | Gélule | B/56 | PHARMAGHREB |
15 | PHLOROGLUCINOL DIHYDRATE | ACTAFON | 160 mg | Comprimé orodispersible | B/30 | ACT PHARMA |
16 | ESOMEPRAZOLE | IPPSIUM 40 | 40 mg | Gélule gastrorésistante | FL/7 | OPALIA PHARMA |
17 | AZITHROMYCINE | AZITHROMIN DUO | 500 mg | Comprimé pelliculé sécable | B/2 | WEST PHARMA |
18 | AZITHROMYCINE | AZITHROMIN TRIO | 500 mg | Comprimé pelliculé sécable | B/3 | WEST PHARMA |
19 | AZITHROMYCINE | AZIX | 1200 mg (40 mg/ ml) | Poudre pour suspension orale | FL/30 ml | PHARMAGHREB |
20 | TIOTROPIUM | TIOTROPIUM EASY FLOW | 18 mcg | Poudre pour inhalation buccale | B/30 gélules + inhalateur | OPALIA PHARMA |
Spécialités Pharmaceutiques importées :
* Produits déjà évalués lors des derniers Comités Techniques
N° | Médicament | DCI | Dosage | Forme Pharmaceutique | Présentation | TITULAIRE |
1 | LATAZ 0,005% | LATANOPROST | 50 mcg/ml | Collyre | FL/2.5 ML | RAFARM SA |
2 | LATAZ 0CO | LATANOPROST+TIMOLOL | Collyre | FL/2.5 ML | RAFARM SA | |
3 | OPTODROP-CO | DORZOLAMIDE +TIMOLOL | Collyre | FL/5 ML | RAFARM SA | |
4 | AUBAGIO | TERIFLUNOMIDE | COMPRIME PELLICULE | B/28 | SANOFI AVENTIS | |
5 | SMOFKABIVEN E | SOLUTION ACIDES AMINES | 1600Kcal | EMULSION PERFUSION | B/4 POCHES | FRESENIUS KABI France |
6 | SMOFKABIVEN E | SOLUTION ACIDES AMINES | 1100Kcal | EMULSION PERFUSION | B/4 POCHES | FRESENIUS KABI France |
7 | SMOFKABIVEN E | SOLUTION ACIDES AMINES | 2200Kcal | EMULSION PERFUSION | B/4 POCHES | FRESENIUS KABI France |
8 | FRAGOR | DELAPRIDE+MANIDIPINE | 30mg+10mg | COMPRIME | B/28 | CHIESI Italie |
9 | DIANEAL PD4 | GLUCOSE+ELECTROLYTES | 2,27 | SOL DIALYSE PERI | POCHE 2L | BAXTER UK |
10 | DIANEAL PD4 | GLUCOSE+ELECTROLYTES | 1,36 | SOL DIALYSE PERI | POCHE 5L | BAXTER UK |
11 | DIANEAL PD4 | GLUCOSE+ELECTROLYTES | 1,36 | SOL DIALYSE PERI | POCHE 2L | BAXTER UK |
12 | DIANEAL PD4 | GLUCOSE+ELECTROLYTES | 2,27 | SOL DIALYSE PERI | POCHE 5L | BAXTER UK |
13 | BICALUTAMIDE ACCORD | BICALUTAMIDE | 50MG | COMPRIME PELLICULE | B/28 | ACCORD HAELTHCARE |
14 | OFEV | NINTEDANIB | 100mg | CAPSULE MOLLE | B/60 | BOEHRINGER |
15 | OFEV | NINTEDANIB | 150mg | CAPSULE MOLLE | B/60 | BOEHRINGER |
16 | OPDIVO | NIVOLUMAB | 100 mg/10 ml | SOL INJECTABLE | B/1FL/10ml | BMS |
17 | EFIENT | PRASUGREL | 5MG | COMPRIME | B/28 | DAIICHI SANKYO EUROPE |
18 | EFIENT | PRASUGREL | 10MG | COMPRIME | B/28 | DAIICHI SANKYO EUROPE |
19 | VIGAMOX | MOXIFLOXACINE | 5MG/ML | COLLYRE | FL/5ML | ALCON |
20 | TRESIBA FLEXTACH | INSULINE DEGLUDEC | 100 U/ ML | stylos préremplis de 3 ml | B/3 | NOVO NORDISK A/S |
21 | TRESIBA FLEXTACH | INSULINE DEGLUDEC | 200 U/ ML | stylos préremplis de 3 ml | B/3 | NOVO NORDISK A/S |
22 | ORFADIN | NITISINONE | 4MG/ML | SUSP ORALE | FL/90ML | SOBI |
23 | ORFADIN | NITISINONE | 20MG | gelule | FL/60 | SOBI |
24 | KIVEXA | ABACAVIR/LAMIVUDINE | 600/300MG | COMPRIME PELLICULE | B/30 | VIIV HAETHCARE |
25 | SURVANTA | BERACTANT | 100mg/4ml | susp,intrachéale | FL/8ML | ABBVIE CORPORATION |
26 | SURVANTA | BERACTANT | 200mg/8ml | susp,intrachéale | FL/8ML | ABBVIE CORPORATION |
27 | ALYOSTAL PRICK-TEST CONTRÔLE POSITIF | HISTAMINE HCL | SOLUTION AQUEUSE | FL/3ML | STALLERGENE SA | |
28 | ALYOSTAL PRICK-TEST TEMOIN NEGATIF | TEMOIN NEGATIF | SOLUTION AQUEUSE | FL/3ML | STALLERGENE SA | |
29 | ALYOSTAL PRICK | EXTRAIT ALLERGENIQUE | SOLUTION AQUEUSE | FL/3ML | STALLERGENE SA | |
30 | PIPERACILLINE TAZOBACTAM KABI | PIPERACILLINE TAZOBACTAM | 2GR/250MG | PDRE,INJ,PERF | B/10FL | FREISINUS KABI |
31 | PIPERACILLINE TAZOBACTAM KABI | PIPERACILLINE TAZOBACTAM | 2GR/250MG | PDRE,INJ,PERF | B/10FL | FREISINUS KABI |
* Produits à évaluer pour la première fois au Comité Technique
N° | Médicament | DCI | Dosage | Forme Pharmaceutique | Présentation | TITULAIRE |
1 | JEVTANA | CABAZITAXEL | 60MG | SOL INJ PERFUSION | B/1FL+1FL SLVT | SANOFI AVENTIS France |
2 | CAMPTO | IRINOTECAN | 20MG/ML | SOL INJ PERFUSION | B/1FL/2ML | PFIZER HOLDING |
3 | CAMPTO | IRINOTECAN | 20MG/ML | SOL INJ PERFUSION | B/1FL/5ML | PFIZER HOLDING |
4 | CAMPTO | IRINOTECAN | 20MG/ML | SOL INJ PERFUSION | B/1FL/15ML | PFIZER HOLDING |
5 | VARGATEF | NINTEDANIB | 100MG | CAPSULES MOLLES | B/120 | BOEHRINGER |
6 | SUTENT | SUNITINIB | 12,5MG | GELULES | B/28 | PZIFER LTD |
7 | SUTENT | SUNITINIB | 25MG | GELULES | B/28 | PZIFER LTD |
8 | SUTENT | SUNITINIB | 50MG | GELULES | B/28 | PZIFER LTD |
9 | DECAPEPTYL LP | TRIPTORELINE | 3MG | PDRE PREP INJ | B/1FL+SLVT | IPSEN PHRAMA |
10 | AFINITOR | EVEROLIMUS | 5MG | COMPRIME | B/30 | NOVARTIS |
11 | AFINITOR | EVEROLIMUS | 10MG | COMPRIME | B/30 | NOVARTIS |
12 | KEVESEY | LEVITIRACETAM | 5MG/ML | SOL,INJ | B/10POCHES | STRAGEN |
13 | KEVESEY | LEVITIRACETAM | 10MG/ML | SOL,INJ | B/10POCHES | STRAGEN |
14 | KEVESEY | LEVITIRACETAM | 15MG/ML | SOL,INJ | B/10POCHES | STRAGEN |
15 | MONTELUKAST MYLAN | MONTELUKAST | 5MG | COMPRIME A CROQUER | B/28 | MYLAN SAS |
16 | ATROPINE SULFATE AGUETTANT | ATROPINE SULFATE | 0,5MG | SOL INJ | B/10/5ML | AGUETTANT |
17 | ATACAND | CANDESERTAN CILEXETIL | 4MG | COMPRIME SECABLE | B/30 | ASTRA ZENECA |
18 | ATACAND | CANDESERTAN CILEXETIL | 8MG | COMPRIME SECABLE | B/30 | ASTRA ZENECA |
19 | ATACAND | CANDESERTAN CILEXETIL | 16MG | COMPRIME SECABLE | B/30 | ASTRA ZENECA |
20 | DOBUTAMINE MYLAN | DOBUTAMINE | 250MG/20ML | SOL INJ | B/10/20ML | MYLAN SAS |
21 | BRONCHODUAL | FENOTEROL+IPRATROPIUM | 50µG/20µG | SOL INHAL | FL/200DOSES | BOEHRINGER INGELHEIM |
22 | STELARA | USTEKINUMAB | 45MG/0,5ML | SOL INJ | B/1FL | JANSSEN-CILAG |
23 | STELARA | USTEKINUMAB | 45MG/0,5ML | SOL INJ | B/1 SERINGUE PRE-REMPLIE | JANSSEN-CILAG |
24 | STELARA | USTEKINUMAB | 90MG/ML | SOL INJ | B/1 SERINGUE PRE-REMPLIE | JANSSEN-CILAG |
25 | HYALOSILVER | HYALURONATE DE SODIUM | 0,002 | PDRE USAGE EXTERNE | FL/125ML | FIDIA PHARMACEUTICAL |
26 | ALDURAZYME | LARONIDASE | 100U/ML | CONCENTRE STERILE | B/1FL | GENZYME |
27 | EPIDUO | ADAPALENE+PEROXYDE DE BENZOYLE | 0,1%+2,5% | GEL | FL/30GR | GALDERMA |
28 | MEROPENEM KABI | MEROPENEME TRIHYDRATE | 1GR | SOL,INJ | B/10FL/20ML | FREISINIUS KABI |
29 | FACTANE | FACTEUR VIII | 1000UI/5ML | LYOPHILISAT SOL INJ | B/+1FL SLVT | LFB-BIOMEDICAMENT |
30 | FACTANE | FACTEUR VIII | 2000UI/10ML | LYOPHILISAT SOL INJ | B/+1FL SLVT | LFB-BIOMEDICAMENT |
31 | SINOVIAL | HYALURONATE DE SODIUM | 16MG/2ML | SOL INJ | B/3 SERINGUES | IBSA FARMACEUTICI |
32 | NEBILET | NEBIVOLOL | 5MG | COMPRIME SECABLE | B/30 | MENARINI SA |
33 | PROLUTEX | PROGESTERONE | 25MG | SOL INJ | B/7FL | IBSA SUISSE |
34 | MOONIA | DESOGESTREL | 75µG | COMPRIME | B/28 | STRAGEN UK |
35 | FLUTIFORM | FLUTICASONE+FORMOTEROL | 125µG/5µG | SUSP. INHAL | B/1FL/120DOSES | NAPP PHARMACEUTICAL |
36 | FLUTIFORM | FLUTICASONE+FORMOTEROL | 50µG/5µG | SUSP. INHAL | B/1FL/120DOSES | NAPP PHARMACEUTICAL |
37 | HUMIRA | ADALILUMAB | 40MG | SOL.INJECTABLE | B/2SERINGUES/0,4ML | ABBVIE |
38 | BIOMAG ARGUMES | PRDTS HOMEOPATHIQUES | COMPRIME CROQUER | B/90 | LEHNING | |
39 | OSCILLOCOCCINUM 200 | PRDTS HOMEOPATHIQUES | GRANULES | B/6 | BOIRON | |
40 | OSCILLOCOCCINUM 200 | PRDTS HOMEOPATHIQUES | GRANULES | B/3 | BOIRON | |
41 | MERCURE SOL COMPLEXE N°39 | PRDTS HOMEOPATHIQUES | COMPRIME SUBLINGUAL | B/60 | LEHNING | |
42 | BISEPTINE | BENZALKONIUM+CHLORH | SOLUTION EXTERNE | FL/100ML | BAYER France | |
43 | MONTELUKAST SANDOZ | MONTELUKAST | 5MG | COMPRIME A CROQUER | B/28 | SANDOZ FRANCE |
44 | MONTELUKAST SANDOZ | MONTELUKAST | 10MG | COMPRIME A CROQUER | B/28 | SANDOZ FRANCE |