Dossiers d'AMM à étudier par le Comité Technique des Spécialités Pharmaceutiques du 10/11/2021.
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 Rapport |
| 1 | PENTOP | PANTOPRAZOLE | 40 mg | Gélule gastrorésistante | B/8 | PHARMACARE | E | N | 11/10/2021 |
| 2 | PENTOP | PANTOPRAZOLE | 20 mg | Gélule gastrorésistante | B/8 | PHARMACARE | E | N | 11/10/2021 |
| 3 | VANCO 1G | VANCOMYCINE | 1 g | Pdre p.prep.injectable | B/1 FLACON | LES LABORATOIRES MEDIS | E | N | 20/10/2021 |
| 4 | DICLOFEN GEL | DICLOFENAC | 1% | Gel dermique | T/50 g | DAR-ESSAYDALI. | C | N | 02/11/2021 |
| 5 | VEZIA | DIENOGEST | 2mg | Comprimé | BT/28 | LINO PHARMA | E | N | 02/11/2021 |
| 6 | VEZIA | DIENOGEST | 2 mg | Comprimé | B/84 | LINO PHARMA | E | N | 02/11/2021 |
| 7 | THERADIAM | GLICLAZIDE | 60 mg | Comprimé à libération modifiée | B/60 | THERA | E | N | 04/11/2021 |
| 8 | THERADIAM | GLICLAZIDE | 60 mg | Comprimé à libération modifiée | B/30 | THERA | E | N | 04/11/2021 |
| 9 | ROVASTINE | ROSUVASTATINE | 10 mg | Comprimé pelliculé | B/30 | GALPHARMA | E | N | 04/11/2021 |
| 10 | ROVASTINE | ROSUVASTATINE | 5 mg | Comprimé pelliculé | B/30 | GALPHARMA | E | N | 04/11/2021 |
| 11 | ROVASTINE | ROSUVASTATINE | 20 mg | Comprimé pelliculé | B/30 | GALPHARMA | E | N | 04/11/2021 |
| 12 | TRICIDINE PLUS | ACIDE FUSIDIQUE+BETAMETHASONE | 2% / 0.1% | CREME DERMIQUE | TUBE/15 g | WEST PHARMA | E | V | 05/11/2021 |
| 13 | CIPROMAX 750 | CIPROFLOXACINE | 750 mg | Comprimé pelliculé sécable | B/14 | PHARMACARE | E | N | 05/11/2021 |
| 14 | CIPROMAX 500 | CIPROFLOXACINE | 500 mg | Comprimé pelliculé sécable | B/14 | PHARMACARE | E | N | 05/11/2021 |
| 15 | PSORIS | CLOBETASOL | 500 µg/gr | Shampooing | B/1Fl/125ML | SIMED | E | N | 05/11/2021 |
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 | PRILIGY | DAPOXETINE | 30 mg | COMP PL | B/3 | MENARINI Ind.Farmaceutiche Riunite SRL | V | N | 25/05/2021 |
| 2 | PRILIGY | DAPOXETINE | 60 mg | COMP PL | B/3 | MENARINI Ind.Farmaceutiche Riunite SRL | V | N | 25/05/2021 |
| 3 | RANEXA | RANOLAZINE | 750 mg | COMP LP | B/60 | Menarini International Operation Luxembourg S.A | E | N | 01/06/2021 |
| 4 | RANEXA | RANOLAZINE | 500 mg | COMP LP | B/60 | Menarini International Operation Luxembourg S.A | E | N | 01/06/2021 |
| 5 | SUXAMETHONIUM CHLORID VUAB | SUXAMETHONIUM | 100 mg | PDRE PR SUSP INJ | B/1FL | VUAB PHARMA AS | V | N | 02/06/2021 |
| 6 | LUCENTIS | RANIBIZUMAB | 10MG/ML | SOL INJ | B/1FL | NOVARTIS PHARMA | E | V | 02/06/2021 |
| 7 | ARCHIFAR | MEROPENEME | 1 GR | PDRE PR SOL INJ | B/1FL | MEDOCHEMIE CHYPRE | N | E | 15/06/2021 |
| 8 | ARCHIFAR | MEROPENEME | 0,5 GR | PDRE PR SOL INJ | B/1FL | MEDOCHEMIE CHYPRE | N | E | 15/06/2021 |
| 9 | LEUPRO-SANDOZ DÉPOT 1 MOIS | LEUPRORELINE | 3.6 mg | SERINGUE PRE REML | B/1 | Sandoz Pharma GmbH Allemagne | N | V | 22/06/2021 |
| 10 | LEUPRO-SANDOZ DÉPOT 3 MOIS | LEUPRORELINE | 5 mg | SERINGUE PRE REML | B/1 | Sandoz Pharma GmbH Allemagne | N | V | 22/06/2021 |
| 11 | TARGINACT | OXYCODONE+NALOXONE | 40mg/20mg | COMP LP | B/56 | Napp Pharmaceuticals Limited | V | N | 13/07/2021 |
| 12 | TARGINACT | OXYCODONE+NALOXONE | 10mg/5mg | COMP LP | B/56 | Napp Pharmaceuticals Limited | V | N | 13/07/2021 |
| 13 | TARGINACT | OXYCODONE+NALOXONE | 20mg/10mg | COMP LP | B/56 | Napp Pharmaceuticals Limited | V | N | 13/07/2021 |
| 14 | BRINTELLIX | VORTIOXETINE | 10 mg | COMP PEL | B/28 | H.LUNDBECK A/S | E | N | 30/07/2021 |
| 15 | TARKA FORTE | VERAPAMIL+ TRANDOLAPRIL | 240 MG/4MG | COMPRIME PELLICULE | B/28 | ABBOT-TURQUIE | E | N | 05/08/2021 |
| 16 | TARKA | VERAPAMIL+ TRANDOLAPRIL | 180 MG/2MG | COMPRIME PELLICULE | B/28 | ABBOT-TURQUIE | E | N | 05/08/2021 |
| 17 | RILUZOLE MYLAN 50 | RILUZOLE | 50 mg | COMP PEL | B/56 | MYLAN S.A.S | E | N | 18/08/2021 |
| 18 | CLARISCAN | MEGLUMINE GODATERATE | 0.5mmol/ml | SOL INJ | B/10FL/15 ML | GE HEALTHCARE AS NORVEGE | E | N | 18/08/2021 |
| 19 | CLARISCAN | MEGLUMINE GODATERATE | 0.5mmol/ml | SOL INJ | B/10FL/10 ML | GE HEALTHCARE AS NORVEGE | E | N | 18/08/2021 |
| 20 | CLARISCAN | MEGLUMINE GODATERATE | 0.5mmol/ml | SOL INJ | B/10FL/20 ML | GE HEALTHCARE AS NORVEGE | E | N | 18/08/2021 |
| 21 | ZAVICEFTA | CEFTAZIDIME+AVIBACTAM | 2g/0.5g | PDRE PR PREP INJ | B/10FL | PFIZER Ireland Pharmaceuticals | N | 02/09/2021 | |
| 22 | CORYZALIA | ALLIUM CEPA+BELLADONA... | SOL BUV | B/20 unidoses/1ml | BOIRON | C | N | 08/09/2021 | |
| 23 | GRANOCYTE | LENOGRASTIM | 34 MIL UI/ML | PDRE PR PREP INJ | B/5FL | SANOFI AB | V | N | 15/09/2021 |
| 24 | SIMULECT | BASILIXIMAB | 20 mg | PDRE PR PREP INJ | B/1FL | NOVARTIS PHARMA SCHWEIZ AG | V | N | 23/09/2021 |
| 25 | CETROTIDE | CETRORELIX | 0.25 MG | PDRE PR PREP INJ | B/1FL | MERCK EUROPE B.V | E | N | 23/09/2021 |
| 26 | DROPERIDOL AGUETTANT | DROPERIDOL | 1.25 mg/ml | SOL INJ | B/10AMP | AGUETTANT | E | N | 04/10/2021 |
| 27 | COLLYRE BLEU LAITIER FL/10 ML | METHYLTHIONIUM+NAPHAZOLINE | 0.020 g/0.050 g | COLLYRE | FL/10 ML | NEITUM | E | N/T | 08/10/2021 |
| 28 | MERIONAL HG | GONADOTROPHINE MENOPAUSIQUE HUMAINE | 150 UI/ML | PDRE PR PREP INJ | B/1FL | IBSA Institut Biochimique SA | E | N | 29/10/2021 |
| 29 | MERIONAL HG | GONADOTROPHINE MENOPAUSIQUE HUMAINE | 75UI/ML | PDRE PR PREP INJ | B/1FL | IBSA Institut Biochimique SA | E | N | 29/10/2021 |
* 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 | ENTEROGERMINA | SPORE DE BACILLUSCLAUSII | 4 Milliards | Susp buvable | B/10 FL | SANOFI AVENTIS | C | N/R | 12/07/2021 |
| 2 | PENTASA | MESALAZINE | 4 g | GRANULES LP | B/50 sachets | FERRING GmbH | V | N | RE 20/08/2021 |
| 3 | CADUET | AMLODIPINE+ATORVASTATINE | 10 mg/10 mg | COMP PEL | B/30 | PFIZER PFE FRANCE | E | T | 07/09/2021 |
| 4 | CADUET | AMLODIPINE+ATORVASTATINE | 5 mg/10 mg | COMP PEL | B/30 | PFIZER PFE FRANCE | E | T | 07/09/2021 |
| 5 | TAHOR | ATORVASTATINE | 80 mg | COMP PEL | B/28 | E | T | 13/09/2021 | |
| 6 | ICAZ LP | ISRADIPINE | 2.5 mg | GELULES LP | B/30 | Laboratorio Farmaceutico SIT S.r.l. | E | T | 16/09/2021 |
| 7 | EFEXOR.XL | VENLAFAXINE | 150 mg | GELULES LP | B/28 | Upjohn UK Limited | E | T | 28/09/2021 |
| 8 | CARDULAR PP URO | DOXAZOSINE | 4 mg | COMP LP | B/30 | PFIZER OFG GERMANY GmbH | I | T | 28/09/2021 |
| 9 | STALORAL | ALLERGENES | 300 IR/ml | Goutttes buvables | C/3FL/10ML | STALLERGENES S.A | E | N | 05/10/2021 |
| 10 | XANAX RETARD 0,5 | ALPRAZOLAM | 0,5 MG | COMP LP | B/30 | UPJOHN SRL | T | 29/10/2021 | |
| 11 | XANAX RETARD 1 | ALPRAZOLAM | 1 MG | COMP LP | B/30 | UPJOHN SRL | T | 29/10/2021 | |
| 12 | ELOCTA | EFMOROCTOCOG ALFA | 1500UI | PDRE PR SOL INJ | B/1FL | Swedish Orphan Biovitrum International AB(SOBI) | V | N | 03/11/2021 |
| 13 | ELOCTA | EFMOROCTOCOG ALFA | 2000UI | PDRE PR SOL INJ | B/1FL | Swedish Orphan Biovitrum International AB(SOBI) | V | N | 03/11/2021 |
| 14 | ELOCTA | EFMOROCTOCOG ALFA | 3000UI | PDRE PR SOL INJ | B/1FL | Swedish Orphan Biovitrum International AB(SOBI) | V | N | 03/11/2021 |
| 15 | ELOCTA | EFMOROCTOCOG ALFA | 250UI | PDRE PR SOL INJ | B/1FL | Swedish Orphan Biovitrum International AB(SOBI) | V | N | 03/11/2021 |
