Dossiers d'AMM à étudier par le Comité Technique des Spécialités Pharmaceutiques du 19/04/2024.
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 du courrier |
| 1 | BECAVIR | Entecavir | 1 mg | Comprimé pelliculé | F30 | SIPHAT | E | V | CS 25/03/2024 |
| 2 | ENEBRA | ENTECAVIR | 1 mg | Comprimé pelliculé | FL/30 | TAHA PHARMA | E | V | CS 25/03/2024 |
| 3 | ENEBRA | ENTECAVIR | 0.5 mg | Comprimé pelliculé | FL/30 | TAHA PHARMA | E | V | CS 25/03/2024 |
| 4 | ENTAVIR | ENTECAVIR | 0.5 mg | Comprimé pelliculé | B/30 | SAIPH | E | V | CS 25/03/2024 |
| 5 | ENTAVIR | ENTECAVIR | 1 mg | Comprimé pelliculé | B/30 | SAIPH | E | V | CS 25/03/2024 |
| 6 | PRIMPERAN | METOCLOPRAMIDE | 0.1% | Solution buvable | FL/200 ML | SIPHAT | E | V | CS 25/03/2024 |
| 7 | SULFAGUANIDINE | SULFAGUANIDINE | 500 MG | Comprimé | B/20 | SIPHAT | E | V | CS 25/03/2024 |
| 8 | SULFAGUANIDINE | SULFAGUANIDINE | 500 MG | Comprimé | B/500 | SIPHAT | E | V | CS 25/03/2024 |
| 9 | TRIPYLORI | BISMUTH +METRONIDAZOLE+TETRACYCLINE | 125mg/125mg/140mg | Gélule | B/1fl/120 | SAIPH | E | V | CS 25/03/2024 |
| 10 | CARDOSYL | PERINDOPRIL | 5 mg | COMPRIMÉ PELLICULÉ | Flacon/30 | ADWYA | E | N | 29/03/2024 |
| 11 | CARDOSYL | PERINDOPRIL | 10 mg | COMPRIMÉ PELLICULÉ | Flacon/30 | ADWYA | E | N | 29/03/2024 |
| 12 | NEOFEN | IBUPROFEN | 100 mg/5 ml | SUSPENSION BUVABLE | FL/125 ml | SAIPH | E | N | 29/03/2024 |
| 13 | BACTRIM NOURRISSONS ET ENFANT | COTRIMOXAZOLE | 200 MG/40MG | SUSP BUV | FL/100 ML | TERIAK | E | V | CS 15/04/2024 |
| 14 | BACTRIM FORTE | COTRIMOXAZOLE | 800MG/160MG | COMP | B/10 | TERIAK | E | V | CS 15/04/2024 |
| 15 | BACTRIM | COTRIMOXAZOLE | 400MG/80 MG | COMP | B/20 | TERIAK | E | V | CS 15/04/2024 |
| 16 | OFLOJECT | OFLOXACINE | 200MG/40ML | SOL INJ PR PF | B/10POCHE | UNIMED | E | V | CS 15/04/2024 |
| 17 | OFLOJECT | OFLOXACINE | 200MG/40ML | SOL INJ PR PF | B/1F/40ML | UNIMED | E | V | CS 15/04/2024 |
| 18 | OFLOJECT | OFLOXACINE | 200MG/40ML | SOL INJ PR PF | B/10POCHES | UNIMED | E | V | CS 15/04/2024 |
| 19 | CIPROSAIPH | CIPROFLOXACINE | 500 MG | COMP PEL SEC | B/14 | SAIPH | E | V | CS 15/04/2024 |
| 20 | SIFLOXS | COPROFLOXACINE | 750 MG | CP PEL SEC | B/28 | TERIAK | E | V | CS 15/04/2024 |
| 21 | SIFLOXS | COPROFLOXACINE | 750 MG | CP PEL SEC | B/14 | TERIAK | E | V | CS 15/04/2024 |
| 22 | SIFLOXS | COPROFLOXACINE | 500 MG | CP PEL SEC | B/14 | TERIAK | E | V | CS 15/04/2024 |
| 23 | SIFLOXS | COPROFLOXACINE | 500 MG | CP PEL SEC | B/28 | TERIAK | E | V | CS 15/04/2024 |
| 24 | CIFLOXET | CIPROFLOXACINE | 200 MG | SOL INJ | FL/100 ML | DORCAS | E | V | CS 15/04/2024 |
| 25 | CIFLOXET | CIPROFLOXACINE | 200 MG | SOL INJ | FL/6FL/100ML | DORCAS | E | V | CS 15/04/2024 |
| 26 | CIPROJECT | CIPROFLOXACINE | 200MG/100ML | SOL INJ PR PF | POCHE MULTICOUCHE | UNIMED | E | V | CS 15/04/2024 |
| 27 | CIPROJECT | CIPROFLOXACINE | 200MG/100ML | SOL INJ PR PF | POCHE /100L | UNIMED | E | V | CS 15/04/2024 |
| 28 | CIPROJECT | CIPROFLOXACINE | 400MG/200ML | SOL INJ PR PF | POCHE /200L | UNIMED | E | V | CS 15/04/2024 |
| 29 | ADYFLU | OSELTAMIVIR | 75 mg | Gélule | B/10 | ADWYA | E | V | CS 15/04/2025 |
| 30 | ABIRATERONE ACETATE NEAPOLIS | abiraterone | 250 mg | comprimé | B/120 | NEAPOLIS | E | V | CS 17/04/2024 |
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 | OGIVRI | TRANSTUZUMAB | 150 MG | PPINJ | B/1FL | Biosimilar Collaborations Ireland Limited ("BCIl") | V | N | 26/02/2024 |
| 2 | OGIVRI | TRANSTUZUMAB | 150 MG | PPINJ | B/1FL | Biosimilar Collaborations Ireland Limited ("BCIl") | V | N | 26/02/2024 |
| 3 | ENSPRYNG | SATRALIZUMAB | 120 mg/1 ml | SOL INJ | B/1 | Roche Pharma (Schweiz) AG | N | 19/03/2024 | |
| 4 | DICYNONE | ETAMSYLATE | 250 MG/2ML | SOL INJ | B/6/2ML | OM PHARMA SA | C | N | 29/03/2024 |
| 5 | DICYNONE | ETAMSYLATE | 500 MG | COMP | B/20 | OM PHARMA SA | C | N | 29/03/2024 |
* Produits à évaluer pour la première fois au Comité Technique
| Médicament | DCI | Dosage | Forme Pharmaceutique | Présentation | TITULAIRE | VEIC | Type de la demande | DATE RE | |
| 1 | DARZALEX | daratumumab | 400mg/20 ML | SOL INJ | B/1FL/20ML | Janssen-Cilag International N.V | E | V | CS 07/02/2024 |
| 2 | DARZALEX | daratumumab | 400mg/20 ML | SOL INJ | B/1FL/5ML | Janssen-Cilag International N.V | E | V | CS 07/02/2024 |
| 3 | DARZALEX | daratumumab | 1800 mg | SOL INJ | B/1FL/5ML | Janssen-Cilag International N.V | E | N | CS 07/02/2024 |
| 4 | BRUKINSA | ZANUBRUTINIB | 80 mg | GELULE | FL/120 | BeiGene USA,Inc | N | CS 07/02/2024 | |
| 5 | CURACNE | ISOTRETINOINE | 20 MG | CAPSULE MOLLE | B/30 | PIERRE FABRE MEDICAMENT | I | T | 16/02/2024 |
| 6 | CURACNE | ISOTRETINOINE | 5 MG | CAPSULE MOLLE | B/30 | PIERRE FABRE MEDICAMENT | I | T | 16/02/2024 |
| 7 | PHENYLEPHRINE | PHENYLEPHRINE | 50 microgrammes/ml | SOL INJ | B/10 | LABORATOIRE AGUETTANT | N | 16/02/2024 | |
| 8 | VIACORIND | PERINDOPRIL ARGININE+ INDAPAMIDE+ AMLODIPINE | 7 mg/2.5mg/5 mg | COMP | B/30 | SERVIER | E | N | 16/02/2024 |
| 9 | POLIVY | POLATUZUMAB VEDOTINE | 140 mg | SOL PR PF | FL/20 ml | HOFFMAN-LA-ROCHE INC. | V | N | 21/02/2024 |
| 10 | EPITAM | LEVETIRACETAM | 500 mg | SOL INJ PR PF | B/1 FL/5ML | HIKMA Pharmaceuticals | E | N | 21/02/2024 |
| 11 | NOZINAN | LEVOMEPROMAZINE | 4% | SOL BUV | FL/30ML | NEURAXPHARM FRANCE | T | 27/02/2024 | |
| 12 | SURMONTIL | TRIMIPRAMINE | 4% | SOL BUV | FL/30ML | NEURAXPHARM FRANCE | T | 27/02/2024 | |
| 13 | VIPIDIA | ALOGLIPTINE | 12,5 mg | COMP PEL | B/28 | THE ARAB PHARMACEUTICAL MANUFACTURING PSC | E | N | 28/02/2024 |
| 14 | VIPIDIA | ALOGLIPTINE | 25 mg | COMP PEL | B/28 | THE ARAB PHARMACEUTICAL MANUFACTURING PSC | E | N | 28/02/2024 |
| 15 | NOVOSEVEN | Facteur VII A | 1 MG | PDRE PR PREP INJ | B/1FL | NOVO NORDISK A/S BAGSFAERD | V | V | CS 29/02/2024 |
| 16 | NOVOSEVEN | Facteur VII A | 2 MG | PDRE PR PREP INJ | B/1FL | NOVO NORDISK A/S BAGSFAERD | V | V | CS 29/02/2024 |
| 17 | NOVOSEVEN | Facteur VII A | 5 MG | PDRE PR PREP INJ | B/1FL | NOVO NORDISK A/S BAGSFAERD | V | V | CS 29/02/2024 |
| 18 | TAMIFEN | TAMOXIFENE | 10 MG | COMP SECABLE | B/30 | MEDOCHEMIE LTD | V | V | CS 29/02/2024 |
| 19 | RHOPHYLAC | IMMUNOGLOBULINE HUMAINE ANTI D | 300µg/2ml | Sol inj | B/1 | CSL BEHRING AG | V | V | CS 29/02/2024 |
| 20 | PHARMATEX | CHLORURE DE BENZALKONIUM | 18,9 MG | CAPSULE MOLLE VAGI | B/6 | INNOTECH INTERATIONAL | I | V | CS 29/02/2024 |
| 21 | PHARMATEX | CHLORURE DE BENZALKONIUM | 18,9 MG | CAPSULE MOLLE VAGI | B/20 | INNOTECH INTERATIONAL | I | V | CS 29/02/2024 |
| 22 | BLISSEL | ESTRIOL | 50 µg/g | GEL VAGINAL | T/20G | ITALFARMACO ESPAGNE | I | V | CS 29/02/2024 |
| 23 | SLINDA | DROSPIRENONE | 4 mg | COMP PEL | B/ 24+4 | EXELTIS HEALTHCARE,S.L | E | N | CS 29/02/2024 |
| 24 | AVONEX | INTERFERON BETA-1A | 30 µg/0.5 ml | SOL NJ | B/4 stylos pré-remplis | BIOGEN NETHERLANDS B.V. | E | T | 29/02/2024 |
| 25 | NEULEPTIL | PROPERICIAZINE | 4% | GTTES BUV | FL/30 ML | NEURAXPHARM FRANCE | E | N | 03/05/2024 |
| 26 | IMUREK | AZATHIOPRINE | 50 MG | COMP PEL | B/100 | ASPEN PHARMA TRADING LIMITED | V | V | CS 08/03/2024 |
| 27 | VOLTARENE RETARD | DICLOFENAC | 75 mg | COMP PEL | B/20 | NOVARTIS PHARMA SCHWEIZ AG | E | N | CS 08/03/2024 |
| 28 | PLAQUENIL | HYDROXYCHLOROQUINE | 200 MG | COMP PEL | B/30 | SANOFI AVENTIS FRANCE | E | V | CS 08/03/2024 |
| 29 | DROSBELA DIARIO | DROSPIRENONE+ETHINYLESTRADIOL | 3 mg/0.03 mg | COMP PEL | B/21+7 | EXELTIS HEALTHCARE,S.L | N | 14/03/2024 | |
| 30 | TIORFAN NOURRISSONS ET ENFANTS | RACECADOTRIL | 4 mg/ml | Suspension buvable | FL/50ml | BIOPROJET PHARMA | I | N | CS 25/03/2024 |
| 31 | TIORFAN NOURRISSONS ET ENFANTS | RACECADOTRIL | 4 mg/ml | Suspension buvable | FL/180ml | BIOPROJET PHARMA | I | N | CS 25/03/2024 |
| 32 | STELARA | USTEKINUMAB | 90mg/ml | Solution injectable | B/1Seringue pré-remplie/1ml | Janssen-Cilag International N. | E | V | CS 25/03/2024 |
| 33 | STELARA | USTEKINUMAB | 130mg/26ml | Solution injectable pour perfu | B/1FL/30ML | Janssen-Cilag International N. | E | V | CS 25/03/2024 |
| 34 | STELARA | USTEKINUMAB | 45 mg/0.5ml | Solution injectable | B/1seringue pré-remplie/0.5ml | Janssen-Cilag International N. | E | V | CS 25/03/2024 |
| 35 | Humira | 40 mg | Seringue pré-remplie | seri préremplie/0.4 ml | ADALIMUMAB | Abbvie | E | V | CS 25/03/2024 |
| 36 | ZOLENAT | ACIDE ZOLEDRONIQUE | 4mg/5ML | Sol Concentrée pour Perfusion | B/1FL | GENSENTA ILAC SANAYI-TURQUIE | V | N | 29/03/2024 |
| 37 | UNIMAZOLE | THIAMIZOLE | 10 MG | Cp Pell | B/60 | UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A | N | 29/03/2024 | |
| 38 | UNIMAZOLE | THIAMIZOLE | 5 MG | Cp Pell | B/60 | UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A | N | 29/03/2024 | |
| 39 | TIGECID | TIGECYCLINE | 50 MG | PPINJ | B/10FL | Centurion laç Sanayi ve ticaret A.S. | N | 29/03/2024 | |
| 40 | TALZENNA | talazoparib | 0,25 mg | gelule | FL/30 | PFIZER Europe MA EEIG | E | N | CS 17/04/2024 |
| 41 | TALZENNA | talazoparib | 1 mg | gelule | FL/30 | PFIZER Europe MA EEIG | N | CS 17/04/2024 | |
| 42 | HALAVEN | mesilate d'eribuline | 0.44 mg/ml | Solution injectable | Fl/2ml | Eisai Europe Limited | N | CS 17/04/2024 | |
| 43 | LYNPARZA | olaparib | 100 mg | comprimé pelliculé | B/56 | AstraZeneca AB SUEDE | N | CS 17/04/2024 | |
| 44 | LYNPARZA | olaparib | 150 mg | comprimé pelliculé | B/56 | AstraZeneca AB SUEDE | N | CS 17/04/2024 | |
| 45 | LONSURF | tipiracil/ trifluridine | 20mg/8.19mg | comprimé pelliculé | B/20 | SERVIER | N | CS 17/04/2024 | |
| 46 | LONSURF | tipiracil/ trifluridine | 15mg/6.14mg | comprimé pelliculé | B/20 | SERVIER | N | CS 17/04/2024 | |
| 47 | TAGRISSO | osimertinib | 40 MG | comprimé pelliculé | B/30 | ASTRA ZENECA AB UK | N | CS 17/04/2024 | |
| 48 | TAGRISSO | osimertinib | 80 MG | comprimé pelliculé | B/30 | ASTRA ZENECA AB UK | N | CS 17/04/2024 | |
| 49 | NERLYNX | NERATINIB | 40mg | comprimé pelliculé | B/180 | PIERRE FABRE | N | CS 17/04/2024 |
