Dossiers d'AMM à étudier par le Comité Technique des Spécialités Pharmaceutiques du 23/02/2024.
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 du courrier |
| 1 | TEMOZOLOMIDE NEAPOLIS | TÉMOZOLOMIDE | 100 mg | Poudre pour solution pour perf | B/1FL | NEAPOLIS PHARMA | E | N | CS 29/01/2024 |
| 2 | APRIVA | APREMILAST | 10mg/20mg/30mg | Comprimé pelliculé | B/28 (4/10 mg+4/20 mg+20/30 mg | IBN AL BAYTAR | I | N | CS 31/01/2024 |
| 3 | APRIVA | APREMILAST | 30 mg | Comprimé pelliculé | B/60 | IBN AL BAYTAR | I | N | CS 31/01/2024 |
| 4 | DACTULAC | LACTULOSE | 66.5% | SOLUTION BUVABLE | FL/200ML | PHARMAGHREB | C | N | 15/02/2024 |
* 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 | KARDEGIC | ACETYLSALICYLATE DE LYSINE | 160 mg | Poudre pour solution orale | B/30 sachets | SANOFI AVENTIS PHARMA TUNISIE | E | N | 23/01/2024 |
| 2 | PIRADIUM | DOMPERIDONE | 10 mg | Comprimé pelliculé | B/20 | TAHA PHARMA | I | N | 02/02/2024 |
| 3 | INOVIA 10 | DAPAGLIFLOZINE PROPRANEDIOL | 10 mg | Comprimé pelliculé | B/90 | PHILADELPHIA PHARMA | E | N | 15/02/2024 |
| 4 | INOVIA 5 | DAPAGLIFLOZINE PROPRANEDIOL | 5 mg | Comprimé pelliculé | B/90 | PHILADELPHIA PHARMA | E | N | 15/02/2024 |
| 5 | FUNGALYSE | CASPOFUNGINE | 70 mg | Pdre p.prep.injectable | B/1 flacon | LES LABORATOIRES MEDIS | E | N | 16/02/2024 |
| 6 | FUNGALYSE | CASPOFUNGINE | 50 mg | Pdre p.prep.injectable | B/1 flacon | LES LABORATOIRES MEDIS | E | N | 16/02/2024 |
| 7 | CLADRIBINE NEAPOLIS | CLADRIBINE | 1 mg/ml | Solution injectable pour perfu | B/ 1FL/10ML | NEAPOLIS PHARMA | E | N | 16/02/2024 |
| 8 | ULTRASCAN | IOPROMIDE | 370mg d'iode/ml | Solution injectable | B/1FL/50 ML | LES LABORATOIRES MEDIS | E | N | 16/02/2024 |
| 9 | ULTRASCAN | IOPROMIDE | 370mg d'iode/ml | Solution injectable | B/1FL/100 ML | LES LABORATOIRES MEDIS | E | N | 16/02/2024 |
| 10 | ULTRASCAN | IOPROMIDE | 300mg d'iode/ml | Solution injectable | FL/100 ML | LES LABORATOIRES MEDIS | E | N | 16/02/2024 |
| 11 | ULTRASCAN | IOPROMIDE | 300 mg/ml | Solution injectable | FL/50 ML | LES LABORATOIRES MEDIS | E | N | 16/02/2024 |
| 12 | NIDAZOL | METRONIDAZOLE | 250 mg | Comprimé pelliculé | B/20 | PHARMACARE | E | N | 16/02/2024 |
| 13 | FERVEX ADULTES FRAMBOISE | PARACETAMOL+ PHENIRAMINE+ VITAMINE C | 500 mg/200mg/25mg | Granulés pour suspension buvab | B/8 SACHETS | IPS (Industrie Pharmaceutique | C | N | 16/02/2024 |
| 14 | THIOZYL | THIOCOLCHICOSIDE | 4 mg/2 ml | Solution injectable | B/6 /2 ml | DORCAS | I | N | 16/02/2024 |
| 15 | ROSUVASCOR | ROSUVASTATINE | 10 mg | Comprimé pelliculé | B/30 | ADWYA | E | V | 16/02/2024 |
| 16 | ROSUVASCOR | ROSUVASTATINE | 20 mg | Comprimé pelliculé | B/30 | ADWYA | E | V | 16/02/2024 |
| 17 | ROSUVASCOR | ROSUVASTATINE | 5mg | Comprimé pelliculé | B/30 | ADWYA | E | V | 16/02/2024 |
| 18 | ROSUVASCOR | ROSUVASTATINE | 20 mg | Comprimé pelliculé | B/90 | ADWYA | E | V | 16/02/2024 |
| 19 | ROSUVASCOR | ROSUVASTATINE | 10 mg | Comprimé pelliculé | B/90 | ADWYA | E | V | 16/02/2024 |
| 20 | ROSUVASCOR | ROSUVASTATINE | 5mg | Comprimé pelliculé | B/90 | ADWYA | E | V | 16/02/2024 |
| 21 | FERVEX FERVEX ENFANT SANS SUCRE | PARACETAMOL+ PHENIRAMINE+ VITAMINE C | Granulés pour suspension buvab | B/8 SACHETS | IPS (Industrie Pharmaceutique | C | N | 16/02/2024 | |
| 22 | IVEX SANS SUCRE | EXTRAIT SEC DE FEUILLE DE LIERRE | 7 mg/ml | Sirop | FL/200 ml | SIMED | C | V | 21/02/2024 |
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 | NASONEX | MOMETASONE | 50 MCG/DOSE | Susp NASAL | FL/140 DOSES | ORGANON TECHNIKA FRANCE | E | T | 01/04/2024 |
| 2 | KESIMPTA | OFATUMUMAB | 20 mg/0.4ml | SOL INJ | B/1STYLO | NOVARTIS PHARMA SCHWEIZ AG | N | 17/01/2024 | |
| 3 | ATOSIBAN EVER Pharma | ATOSIBAN | 37.5 mg/ 5 ml | SOL INJ PR PRF | B/1 flacon / 5ml | EVER Valinject GmbH | E | N | 02/06/2024 |
| 4 | ATOSIBAN EVER Pharma | ATOSIBAN | 75 mg/ 10 ml | SOL INJ PR PRF | B/1 flacon / 10ml | EVER Valinject GmbH | E | N | 02/06/2024 |
| 5 | ATOSIBAN EVER Pharma | ATOSIBAN | 6,75 mg/ 0,9 ml | SOL INJ PR PRF | B/1 flacon / 2 ml | EVER Valinject GmbH | E | N | 02/06/2024 |
| 6 | ENSPRYNG | SATRALIZUMAB | 120 mg/1 ml | SOL INJ | B/1 seringue | Roche Pharma (Schweiz) AG | N | 02/07/2024 | |
| 7 | ERIVEDGE | VISMODEGIB | 150 mg | GEL | B/28 | Roche Pharma (Schweiz) AG | N | 02/07/2024 | |
| 8 | CRESEMBA | ISAVUCONAZOLE | 100 MG | GEL | B/14 | HIKMA Pharmaceuticals | N | 19/02/2024 |
* 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 | ZINNAT | CEFUROXIME | 500 mg | Cp Pell | B/10 | SANDOZ PHARMACEUTICALS DD SLOVENIE | |||
| 2 | OLMESATAN MEDOXOMIL & AMLODIPINE /GENEPHARM | AMLODIPINE+OLMESARTAN MEDOXOMIL | 40 mg/5mg | COMP PEL | B/30 | GENEPHARM S.A | E | N | 12/12/2023 |
| 3 | OLMESATAN MEDOXOMIL & AMLODIPINE /GENEPHARM | AMLODIPINE+ OLMESARTAN MEDOXOMIL | 20 mg/5mg | COMP PEL | B/30 | GENEPHARM S.A | E | N | 12/12/2023 |
| 4 | OLMESATAN MEDOXOMIL & AMLODIPINE /GENEPHARM | AMLODIPINE+ OLMESARTAN MEDOXOMIL | 40 mg/10mg | COMP PEL | B/30 | GENEPHARM S.A | E | N | 12/12/2023 |
| 5 | CARDENSIEL | BISOPROLOL | 1.25 mg | COMP PEL | B/30 | Merck Santé s.a.s | E | N | 12/12/2023 |
| 6 | DIBASE | CHOLÉCALCIFÉROL | 50 000 UI /2.5ML | SOL BUV | B/ 1FL | ABIOGEN PHARMA S.p.A | E | N | 13/12/2023 |
| 7 | DIBASE | CHOLÉCALCIFÉROL | 100 000 UI /ML | SOL INJ | B/6 ampoules de 1ml | ABIOGEN PHARMA S.p.A | E | N | 13/12/2023 |
| 8 | DIBASE | CHOLÉCALCIFÉROL | 25 000 UI /2.5ML | SOL BUV | B/ 1FL monodose de 2.5 ml | ABIOGEN PHARMA S.p.A | E | N | 13/12/2023 |
| 9 | DIVINUSMET XR | DAPAGLIFLOZINE PROPANEDIOL / METFORMINE CHLORHYDRATE | 10 mg/1000 mg | COMP PEL | B/30 | HIKMA Pharmaceuticals | N | 13/12/2023 | |
| 10 | DIVINUSMET XR | DAPAGLIFLOZINE PROPANEDIOL / METFORMINE CHLORHYDRATE | 5 mg/1000 mg | COMP PEL | B/60 | HIKMA Pharmaceuticals | N | 13/12/2023 | |
| 11 | TOUJEO SOLOSTAR | INSULINE GLARGINE | 300 UI/ML | SOL INJ | B/3 STYLOS | SANOFI AVENTIS DEUTSCHLAND GmbH | V | V | CS 13/12/2023 |
| 12 | JANUMET | SITAGLIPTINE+METFORMINE | 50 mg/850mg | COMP PEL | B/56 | MERCK SHARP & DOHME BV | E | T | 13/12/2023 |
| 13 | SULIQUA | INSULINE GLARGINE + LIXISENATIDE | 100 Unités/ml + 50 µg/ml | SOL INJ | B/3 Stylos | SANOFI-AVENTIS FRANCE | V | N | 13/12/2023 |
| 14 | SULIQUA | INSULINE GLARGINE + LIXISENATIDE | 100 Unités /ml + 33 µg/ml | SOL INJ | B/3 Stylos | SANOFI-AVENTIS FRANCE | V | N | 13/12/2023 |
| 15 | BAXDELA | DELAFLOXACINE MEGLUMINE | 450 mg | COMP | B/20 | HIKMA Pharmaceuticals | N | CS 14/12/2023 | |
| 16 | BAXDELA | DELAFLOXACINE MEGLUMINE | 300 mg | PDRE PR PREP INJ | B/10FL/20ML | HIKMA Pharmaceuticals | N | CS 14/12/2023 | |
| 17 | MONURIL ADULTE | FOSFOMYCINE | 3 G | GRANULE PR SUSP BUV | B/1SACHET | ZAMBON FRANCE | E | V | CS 14/12/2023 |
| 18 | HEXAXIM | VACCIN D+T+C+P+HB+HIB | SUSP INJ | B/1 SER | SANOFI PASTEUR SA | E | V | CS 11/01/2024 | |
| 19 | CURACNE | ISOTRETINOINE | 40 MG | CAPSULE MOLLE | B/30 | PIERRE FABRE MEDICAMENT . | I | T | 24/01/2024 |
| 21 | TRANXENE | 10 MG | GELULE | B/30 | NEURAXPHARM FRANCE | I | T | 29/01/2024 | |
| 22 | AVASTIN | BEVACIZUMAB | 100 MG | SOL INJ PR PF | B/1FL | ROCHE PHARMA AG | E | V | CS 29/01/2024 |
| 23 | AVASTIN | BEVACIZUMAB | 400 MG | SOL INJ PR PF | B/1FL | ROCHE PHARMA AG | E | V | CS 29/01/2024 |
| 24 | CASODEX | BICALUTAMIDE | 50 MG | COMP ENROBE | B/30 | JUVISE PHARMACEUTICALS | V | T | CS 29/01/2024 |
| 25 | EMEND | APREPITANT | 80mg/125mg | GELULE | B/3 | MERCK SHARP & DOHME BV | C | T | CS 29/01/2024 |
| 26 | ZAVICEFTA | CEFTOZIDIME+ AVIBACTAM | 2G/0,5G | PDRE PR SOL PERF | B/10F | PFIZER IRELAND PHARMA | V | CS 30/01/2024 | |
| 27 | ZERBAXA | CEFTOLOZZANE+ TAZOBACTAM | 1G/0,5G | PDRE PR SOL PERF | B/10F | MERCK SHARP & DOHME UK | E | V | CS 30/01/2024 |
| 28 | BOOSTERIX | VACCIN DIPHTERQUE TETANIQUE COQUELUCHRUX | SUSP INJ | B/1seringues préremplies | GLAXOSMITHKLINE BIOLOGICALS BELGIUM | E | V | CS 30/01/2024 | |
| 29 | INFANRIX HEXA | VACCIN D+T+C+P+HB+HIB | SUSP INJ | B/1FL | GLAXOSMITHKLINE BIOLOGICALS BELGIUM | E | V | CS 30/01/2024 | |
| 30 | RINVOQ | UPADACITINIB | 15 MG | COMP LP | B/28 | ABBVIE DEUTSCHLAND Gmbh and Co.KG | N | CS 31/01/2024 | |
| 31 | XELJANZ XR | TOFACITINIB | 11 mg | COMP LP | B/30 | Pfizer Inc USA | E | N | CS 31/01/2024 |
| 32 | XELJANZ | TOFACITINIB | 5 mg | COMP LP | B/60 | PF PRISM/PFIZER NETHERLANDS | E | V | CS 31/01/2024 |
| 33 | SKYRIZI | RISANKIZUMAB | 150 mg | SOL INJ | B/1 seringue pré-remplie | ABBVIE DEUTSCHLAND Gmbh and Co.KG | E | N | CS 31/01/2024 |
| 34 | SKYRIZI | RISANKIZUMAB | 150 mg | SOL INJ | B/1 stylo pré-rempli | ABBVIE DEUTSCHLAND Gmbh and Co.KG | E | N | CS 31/01/2024 |
| 35 | TREMFYA | GUSELKUMAB | 100mg | SOL INJ | B/1 seringue pré-remplie | Janssen-Cilag International N.V | E | N | 31/01/2024 |
| 36 | TREMFYA | GUSELKUMAB | 100mg | SOL INJ | B/1 stylo pré-rempli | Janssen-Cilag International N.V | E | N | 31/01/2024 |
| 37 | Immunoglubuline humaine à injection intraveineuse (pH4) | IMMUNOGLOBULINE HUMAINE NORMALE | 5g (5%,100 ml) | SOL INJ PR PF | B/1AMP /100 ml | Sichuan Yuanda Shuyang Pharmaceutical Co.,Ltd | N | CS 07/02/2024 | |
| 38 | Immunoglubuline humaine à injection intraveineuse (pH4) | IMMUNOGLOBULINE HUMAINE NORMALE | 2.5 g (5%,50 ml) | SOL INJ PR PF | B/1AMP /50ML | Sichuan Yuanda Shuyang Pharmaceutical Co.,Ltd | N | CS 07/02/2024 | |
| 39 | IG VENA | IMMUNOGLOBULINE HUMAINE POLYVALENTE | 5G/100ML | SOL INJ PR PF | FL/100ML | KEDRION S.P.A | V | V | CS 07/02/2024 |
| 40 | IG VENA | IMMUNOGLOBULINE HUMAINE POLYVALENTE | 2,5G/50ML | SOL INJ PR PF | FL/50ML | KEDRION S.P.A | V | V | CS 07/02/2024 |
| 39 | PRIVIGEN | IMMUNOGLOBULINE HUMAINE POLYVALENTE | 10%(2,5g) | SOL INJ PR PF | FL/25ML | CSL BEHRING AG | I | V | CS 07/02/2024 |
| 40 | PRIVIGEN | IMMUNOGLOBULINE HUMAINE POLYVALENTE | 10% (10 g) | SOL INJ PR PF | FL/100ML | CSL BEHRING AG | I | V | CS 07/02/2024 |
| 41 | PRIVIGEN | IMMUNOGLOBULINE HUMAINE POLYVALENTE | 10% (5g) | SOL INJ PR PF | FL/100ML | CSL BEHRING AG | I | V | CS 07/02/2024 |
| 42 | HAEMOCOMPLETTAN P | FIBRINOGENE | 1 G | PDRE PR SUSP INJ | B/01FL | CSL BEHRING GMBH | V | V | CS 07/02/2024 |
| 43 | DARZALEX | daratumumab | 400mg/20 ML | SOL INJ | B/1FL/20ML | Janssen-Cilag International N.V | V | CS 07/02/2024 | |
| 43 | DARZALEX | daratumumab | 400mg/20 ML | SOL INJ | B/1FL/5ML | Janssen-Cilag International N.V | V | CS 07/02/2024 | |
| 44 | DARZALEX | daratumumab | 1800 mg | SOL INJ | B/1FL/5ML | Janssen-Cilag International N.V | N | CS 07/02/2024 | |
| 45 | BRUKINSA | ZANUBRUTINIB | 80 mg | GELULE | FL/120 | BeiGene USA,Inc | N | CS 07/02/2024 | |
| 46 | PHENYLEPHRINE | PHENYLEPHRINE | 50 microgrammes/ml | SOL INJ | B/10 | LABORATOIRE AGUETTANT | N | 16/02/2024 | |
| 47 | VIACORIND | PERINDOPRIL ARGININE+ INDAPAMIDE+ AMLODIPINE | 7 mg/2.5mg/5 mg | COMP | B/30 | SERVIER | E | N | 16/02/2024 |
| 48 | POLIVY | POLATUZUMAB VEDOTINE | 140 mg | SOL PR PF | FL/20 ml | HOFFMAN-LA-ROCHE INC. | V | N | 21/02/2024 |
| 49 | EPITAM | LEVETIRACETAM | 500 mg | SOL INJ PR PF | B/1 FL/5ML | HIKMA Pharmaceuticals | E | N | 21/02/2024 |
