Dossiers d'AMM à étudier par le Comité Technique des Spécialités Pharmaceutiques du 02/06/2021.
Pour ce comité technique, l’ordre de passage des dossiers sera comme suit .
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 | SIMULECT | BASILIXIMAB | 20 MG | Poudre pour prep injectable | B/ 1FL +S/5ML | NOVARTIS PHARMA | V | N | 15/10/2020 |
2 | TOT'HEMA | CUIVRE+ MANGANESE +FER | 0,7MG/ 1,33MG/ 50MG | SOLUTION BUVABLE | B/20 AMP/10ML | INNOTECH | E | N | 20/10/2020 |
3 | ALECENSA | ALECTINIB | 150 MG | GELULE | B/224 | ROCHE PHARMA (SCHWEIZ) LTD SUISSE | N | 23/10/2020 | |
4 | FORXIGA | DAPAGLIFLOZINE | 5 MG | COMP PEL | B/28 | ASTRA ZENECA | N | 02/11/2020 | |
5 | FORXIGA | DAPAGLIFLOZINE | 10 MG | COMP PEL | B/28 | ASTRA ZENECA | N | 02/11/2020 | |
6 | CETROTIDE | CETRORELIX | 0,25 MG | Poudre pour prep injectable | B/1 FL+SER/1ML | MERCK EUROPE BV | T | 05/11/2020 | |
7 | CYCLOGEST | PROGESTERONE | 400 MG | SUPPOSITOIRE | B/15 | L.D.Collins & Co.ltd | N | 06/11/2020 | |
8 | RILUZOLE MYLAN | RILUZOLE | 50 MG | COMP PELLICULE | B/56 | MYLAN S.A.S | N | 16/11/2020 | |
9 | PRADAXA | DABIGATRAN | 110 MG | GELULE | B/30 | BOEHRINGER INGELHEIM | V | 30/11/2020 | |
10 | PRADAXA | DABIGATRAN | 110 MG | GELULE | B/60 | BOEHRINGER INGELHEIM | V | 30/11/2020 | |
11 | PRADAXA | DABIGATRAN | 150 MG | GELULE | B/60 | BOEHRINGER INGELHEIM | N | 30/11/2020 | |
12 | JANUVIA | SITAGLIPTINE | 100 MG | COMPRIME PELLICULE | B/28 | MERCK SHARP & DOHME BV | E | T | 11/12/2020 |
13 | DIATER POLYMERIZED | EXTRAITS ALLERGENIQUES | SOLUTION INJECTABLE | B/1FL/3ML | M,A,B PHARMA | E | N | 14/12/2020 | |
14 | DIATER POLYMERIZED | EXTRAITS ALLERGENIQUES | SOLUTION INJECTABLE | B/3FL/3ML | M,A,B PHARMA | E | N | 14/12/2020 | |
15 | LEUZAN | TENOFOVIR DISOPROXIL FUMARATE | 300 MG | COMPRIME PELLICULE | B/30 | RICHMOND ARGENTINE | E | N | 26/01/2021 |
16 | COLLYRE BLEU LAITER | METHYLTHIONINIUM + NAPHAZOLINE NITRATE | 0,02 G/0,05G | COLLYRE | F/10ML | NEITUM France | I | N | 27/01/2021 |
17 | GRANOCYTE | LENOGRASTIM | 34 MILLIONS UI/ML | Poudre pour prep injectable | B/5 FL +S/1ML | SANOFI AB | V | N | 29/01/2021 |
18 | XERACTAN | ISOTRETINOINE | 10 MG | CAPSULE MOLLE | B/30 | JAZEERA PHARMACEUTICAL INDUSTRIES | I | N | 08/02/2021 |
19 | XERACTAN | ISOTRETINOINE | 20 MG | CAPSULE MOLLE | B/30 | JAZEERA PHARMACEUTICAL INDUSTRIES | I | N | 08/02/2021 |
20 | JANUMET | SITAGLIPTINE + METFORMINE | 50 mg/1000 mg | comprimé | B/56 | MERCK SHARP & DOHME BV | E | T | 17/02/2021 |
21 | FOSAVANCE | ALENDRONATE+COLECALCIFEROL | 70 mg/5000 UI Cp | Comprimé | B/4 | MERCK SHARP & DOHME BV | E | T | 17/02/2021 |
22 | HEMLIBRA | EMICIZUMAB | 30mg/ml | SOL INJ | B/1FL/1ML | Roche Pharma (Schweiz) AG | V | N | 24/03/2021 |
23 | HEMLIBRA | EMICIZUMAB | 150mg/ml | SOL INJ | B/1FL/1ML | Roche Pharma (Schweiz) AG | V | N | 24/03/2021 |
24 | HEMLIBRA | EMICIZUMAB | 105 mg / 0,7ml | SOL INJ | B/1FL/3ML | Roche Pharma (Schweiz) AG | V | N | 24/03/2021 |
25 | HEMLIBRA | EMICIZUMAB | 60 mg / 0,4ml | SOL INJ | B/1FL/3ML | Roche Pharma (Schweiz) AG | V | N | 24/03/2021 |
26 | OXYCONTIN | OXYCODONE | 10mg | CP à liberation prolongée | B/20 | PURDUE PHARMA | V | E | 27/04/2021 |
27 | OXYCONTIN | OXYCODONE | 15mg | CP à liberation prolongée | B/20 | PURDUE PHARMA | V | E | 27/04/2021 |
28 | OXYCONTIN | OXYCODONE | 20mg | CP à liberation prolongée | B/20 | PURDUE PHARMA | V | E | 27/04/2021 |
29 | OXYCONTIN | OXYCODONE | 30mg | CP à liberation prolongée | B/20 | PURDUE PHARMA | V | E | 27/04/2021 |
30 | OXYCONTIN | OXYCODONE | 40mg | CP à liberation prolongée | B/20 | PURDUE PHARMA | V | E | 27/04/2021 |
31 | TECENTRIQ | ATEZOLIZUMAB | 1200 mg | SOL INJ P PERFUSION | B/1FL/20 ml | ROCHE SUISSE | V | N | 05/05/2021 |
32 | VOTRIENT | PAZOPANIB | 200 MG | COMP | B/30 | NOVARTIS PHARMA | V | N | 17/05/2021 |
33 | VOTRIENT | PAZOPANIB | 400 MG | COMP | B/30 | NOVARTIS PHARMA | V | N | 17/05/2021 |
* 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 | INTRATECT | IMMUNOGLOBULINE HUMAINE POLYVALENTE | 5G/100ML | SOLUTION INJECTABLE POU PERFUSION | FL/100ML | BIOTEST PHARMA GMBH | E | V | 29/12/2020 |
2 | INTRATECT | IMMUNOGLOBULINE HUMAINE POLYVALENTE | 2,5G/50ML | SOLUTION INJECTABLE POU PERFUSION | FL/50ML | BIOTEST PHARMA GMBH | E | V | 29/12/2020 |
3 | LOXEN LP | NICARDIPINE | 50 MG | GELULES | B/60 | CARDIXO- France | E | T | 11/01/2021 |
4 | ZEFFIX | LAMIVUDINE | 100 MG | COMPRIME PELLICULE | B/28 | GLAXOSMITHKLINE (IRELAND) LIMITED | T | 11/01/2021 | |
5 | VICTOZA | LIRAGLUTIDE | 6 MG/ML | SOLUTION INJECTABLE | B/2 STYLOS DE 3ML | NOVO NORDISK A/S | V | V | 12/01/2021 |
6 | RHESONATIV | ANTI-D(RH) immunoglobuline | 625 IU/ML | SOLUTION INJECTABLE | B/1 AMP/2ML | OCTAPHARMA AB | E | V | 12/01/2021 |
7 | NEXIUM | ESOMEPRAZOLE | 40 MG | COMPRIME GASTRO-RESISTANT | B/28 | ASTRAZENECA UL,LTD | E | T | 12/01/2021 |
8 | POLYGYNAX | NEOMYCINE+ NYSTATINE+ POLYMYXINE B | CAPSULE VAGINALE | B/6 | INNOTECH INTERNATIONAL | I | V | 12/01/2021 | |
9 | DIOVENOR | DIOSMINE | 600 MG | COMPRIME PELLICULE | B/30 | INNOTHERA France | C | N | 25/01/2021 |
10 | FORLAX | POLYETHYLENE GLYCOL | 4G | POUDRE POUR SOLUTION ORALE | B/20 | IPSEN CONSUMER HEALTHCARE France | C | T | 25/01/2021 |
11 | NASOALDO | MOMETASONE FUROATE MONOHYDRATE | 50 µg | suspension pour pulvérisation nasale | F/140 DOSES | ALDO UNION S,L- Espagne | N | 05/02/2021 | |
12 | FORTACIN | LIDOCAINE + PRILOCAINE | 150 mg/ML + 50mg /ml | solution cutanée | FL/ 5ML | RECORDATI - IRELAND | N | 22/02/2021 | |
13 | GENEMENT | TADALAFIL | 20 mg | comprimé | B/4 | GENEPHARM S.A | C | N | 04/03/2021 |
14 | GENEMENT | TADALAFIL | 10 mg | comprimé | B/4 | GENEPHARM S.A | C | N | 04/03/2021 |
15 | ACETETE DE TERLIPRESSINE EVER PHARMA | TERLIPRESSINE | 0.2 mg/ml | SOL INJ | B/5 | EVER Valinject GmbH | E | N | 04/03/2021 |
16 | MONCAS | MONTELUKAST | 5 MG | COMP PEL | B/28 | GENEPHARM S.A | E | N | 25/03/2021 |
17 | MONCAS | MONTELUKAST | 10 MG | COMP PEL | B/28 | GENEPHARM S.A | E | N | 25/03/2021 |
18 | MONCAS | MONTELUKAST | 4 MG | COMP PEL | B/28 | GENEPHARM S.A | E | N | 25/03/2021 |
19 | VIAGRA | SILDENAFIL | 100 MG | COMP PEL | B/4 | Upjohn EESV | C | T | 26/03/2021 |
20 | VIAGRA | SILDENAFIL | 25MG | COMP PEL | B/4 | Upjohn EESV | C | T | 26/03/2021 |
21 | VIAGRA | SILDENAFIL | 50 MG | COMP PEL | B/4 | Upjohn EESV | C | T | 26/03/2021 |
22 | LYRICA | PREGABALINE | 75 mg | GELULES | B/56 | Upjohn EESV | V | T | 29/03/2021 |
23 | LYRICA | PREGABALINE | 75 mg | GELULES | B/14 | Upjohn EESV | V | T | 29/03/2021 |
24 | LYRICA | PREGABALINE | 150mg | GELULES | B/56 | Upjohn EESV | V | T | 29/03/2021 |
25 | SUFENTA | SUFENTANIL | 250 µg/5ml | SOL INJ | B/10/5 ml | Piramal Critical Care B.V. | V | T | 31/03/2021 |
26 | EXTEMENT | SILDENAFIL | 25 MG | COMP | B/4 | GENEPHARM S.A | C | N | 01/04/2021 |
27 | EXTEMENT | SILDENAFIL | 100 MG | COMP | B/4 | GENEPHARM S.A | C | N | 01/04/2021 |
28 | EXTEMENT | SILDENAFIL | 50 MG | COMP | B/4 | GENEPHARM S.A | C | N | 01/04/2021 |
29 | XALKORI | CRIZOTINIB | 250 MG | GELULES | FL/60 | PF PRISM C.V | V | V | 01/04/2021 |
30 | XALKORI | CRIZOTINIB | 200 MG | GELULES | FL/60 | PF PRISM C.V | V | V | 01/04/2021 |
31 | KISQALI | RIBOCICLIB SUCCINATE | 200 MG | COMP PEL | B/63 | NOVARTIS PHARMA SCHWEIZ AG | V | V | 01/04/2021 |
32 | IBRANCE | PALBOCICLIB | 125 MG | GELULES | FL/21 | PFIZER INC USA | E | V | 01/04/2021 |
33 | IBRANCE | PALBOCICLIB | 100 MG | GELULES | FL/21 | PFIZER INC USA | E | V | 01/04/2021 |
34 | IBRANCE | PALBOCICLIB | 75 MG | GELULES | FL/21 | PFIZER INC USA | E | V | 01/04/2021 |
35 | FASLODEX | FULVESTANT | 250 mg | SOL INJ | B/2/5ML | ASTRAZENECA UL,LTD | V | V | 01/04/2021 |
36 | ECALTA | ANIDULAFUNGINE | 100 MG | POUDRE POUR PREPARATION INJECTABLE | B/1 FL | PFIZER | T | 14/04/2021 | |
37 | XANAX | ALPRAZOLAM | 0,75 | Gouttes buv | B/1FL/20ml | Upjohn SRL | I | T | |
38 | RAPIFEN | ALFENTANIL | 1 mg (0.5mg/ml) | SOL INJ | B/5/2 ML | Piramal Critical Care B.V. | V | T | 21/04/2021 |
39 | TREMFYA | GUSELKUMAB | 100mg | SOL INJ | B/1SERINGUE | Janssen-Cilag International N.V | N | 27/04/2021 | |
40 | HUMIRA | ADALIMUMAB | 80 mg | SOL INJ | B/1 stylo pré-rempli/0.8 ml | ABBVIE DEUTSCHLAND Gmbh and Co.KG | E | N | 27/04/2021 |
41 | HUMIRA | ADALIMUMAB | 40 mg | SOL INJ | B/2stylo pré-rempli/0.4 ml | ABBVIE DEUTSCHLAND Gmbh and Co.KG | E | N | 27/04/2021 |
42 | HUMIRA | ADALIMUMAB | 20 mg | SOL INJ | B/2SERINGUE/0,2ML | ABBVIE DEUTSCHLAND Gmbh and Co.KG | E | N | 27/04/2021 |
43 | PANTONIX | PANTOPRAZOLE | 40 MG | PDRE PR PREP INJ | B/1FL | JULPHAR | E | N | 17/05/2021 |
44 | CEFODOX | CEFPODOXIME PROXETIL | 100 MG | COMP PEL | B/10 | PHARMA INTERNATIONAL COMPANY | E | V | 19/05/2021 |
45 | CEFODOX | CEFPODOXIME PROXETIL | 200 MG | COMP PEL | B/10 | PHARMA INTERNATIONAL COMPANY | E | V | 19/05/2021 |
46 | ABEVMY | BEVACIZUMAB | 400 mg(25mg/ml) | SOL PR PERFUSION | B/1FL/16ml | MYLAN PHARMACEUTICALS PRIVATE LIMITED | V | N | 21/05/2021 |
47 | ABEVMY | BEVACIZUMAB | 100 mg(25mg/ml) | SOL PR PERFUSION | B/1FL/16ml | MYLAN PHARMACEUTICALS PRIVATE LIMITED | V | N | 21/05/2021 |
48 | PEMZEK PLUS | CANDESARTAN+HYDROCHLOROTHIAZIDE | 8/12,5 MG | COMP PEL | B/28 | ASTRAZENECA SUISSE | E | T | 21/05/2021 |
49 | PEMZEK PLUS | CANDESARTAN+HYDROCHLOROTHIAZIDE | 16/12,5 MG | COMP PEL | B/28 | ASTRAZENECA SUISSE | E | T | 21/05/2021 |
Spécialités Pharmaceutiques fabriquées localement : (Arrêté le le 28/05/2021)
* Produits déjà évalués lors des derniers Comités Techniques
N° | Médicament | DCI | Dosage | Forme Pharmaceutique | Présentation | TITULAIRE | VEIC | Type de demande | DATE Rapport |
1 | CYSTODOSE | FOSFOMYCINE | 3g | granulés pour solution buvable | B/1 sachet | SAIPH | E | N | 05/05/2021 |
2 | LASICARE | FUROSEMIDE | 500 mg | comprimé sécable | B/50 | PHARMACARE | E | N | 05/05/2021 |
3 | NEABETOL | RIBAVIRINE | 40 mg/ml | solution buvable | B/ 1 Flacon | NEAPOLIS PHARMA | E | N | 17/05/2021 |
4 | RISDONE | RISPERIDONE | 1 mg | comprimé | B/20 | PHARMACARE | E | N | 19/05/2021 |
5 | RISDONE | RISPERIDONE | 2 mg | comprimé | B/20 | PHARMACARE | E | N | 19/05/2021 |
6 | RISDONE | RISPERIDONE | 3 mg | comprimé | B/20 | PHARMACARE | E | N | 19/05/2021 |
7 | RISDONE | RISPERIDONE | 4 mg | comprimé | B/20 | PHARMACARE | E | N | 19/05/2021 |
8 | TENSIOVALS DUO | AMLODIPINE+ VALSARTAN | 10 mg/160 mg | comprimé pelliculé | B/30 | TAHA PHARMA | E | V | 25/05/2021 |
9 | TENSIOVALS DUO | AMLODIPINE+ VALSARTAN | 5 mg/160 mg | comprimé pelliculé | B/30 | TAHA PHARMA | E | V | 25/05/2021 |
10 | TENSIOVALS DUO | AMLODIPINE+ VALSARTAN | 5 mg/80 mg | comprimé pelliculé | B/30 | TAHA PHARMA | E | V | 25/05/2021 |
11 | SIPRODIS | CIPROFLOXACINE | 500 mg | comprimé pelliculé sécable | B/14 | GALPHARMA | E | N | 26/05/2021 |
12 | SIPRODIS | CIPROFLOXACINE | 750 mg | comprimé pelliculé sécable | B/14 | GALPHARMA | E | N | 26/05/2021 |
* 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 | GABAMIM | PREGABALINE | 150 mg | gélule | B/60 | GALPHARMA | V | N | 26/04/2021 |
2 | LAPTOR | ATORVASTATINE | 80 mg | comprimé pelliculé sécable | B/90 | TAHA PHARMA | E | N | 26/04/2021 |
3 | RISPER ORO | RISPERIDONE | 2 mg | comprimé orodispersible | B/60 | ADVANS PHARMA | E | N | 26/04/2021 |
4 | ACNODERM | ADAPALENE | 0,10% | GEL | T/ 30 gr | SIMED | I | N | 05/05/2021 |
5 | RGEO | ESOMEPRAZOLE | 40 mg | gélule gastrorésistantes | B/14 | SAIPH | E | N | 17/05/2021 |
6 | RGEO | ESOMEPRAZOLE | 40 mg | gélule gastrorésistantes | B/28 | SAIPH | E | N | 17/05/2021 |
7 | ARTICAINE MEDIS ADRENALINEE | ARTICAINE+ ADRENALINE | 1 / 100 000 | Solution injectable | B/ 25 carpules/1,8 ml | LABORATOIRES MEDIS | E | N | 18/05/2021 |
8 | RHINATHIOL | CARBOCISTEINE | 5% | sirop | FL/300ML | WINTHROP PHARMA TUNISIE | C | T | 18/05/2021 |
9 | CIAPLUS | TADALAFIL | 5 mg | comprimé pelliculé | B/30 | ADWYA | C | N | 19/05/2021 |
10 | ROSUVANS | ROSUVASTATINE CALCIUM | 5 mg | comprimé pelliculé | B/30 | ADVANS PHARMA | E | N | 19/05/2021 |
11 | ROSUVANS | ROSUVASTATINE CALCIUM | 10 mg | comprimé pelliculé | B/30 | ADVANS PHARMA | E | N | 19/05/2021 |
12 | ROSUVANS | ROSUVASTATINE CALCIUM | 20 mg | comprimé pelliculé | B/30 | ADVANS PHARMA | E | N | 19/05/2021 |
13 | RHINATHIOL | CARBOCISTEINE | 2% | sirop | FL/125ML | WINTHROP PHARMA TUNISIE | C | T | 21/05/2021 |
14 | ABIRATERONE ACETATE NEAPOLIS | ABIRATERONE | 250 mg | comprimé pelliculé | B/120 | NEAPOLIS PHARMA | V | N | 21/05/2021 |
15 | ASMATHYL | MONTELUKAST | 10 mg | comprimé à croquer | B/30 | GALPHARMA | E | N | 21/05/2021 |
16 | LIDOCA PLUS | LIDOCAINE+PRILOCAINE | 5% | crème dermique | T/5 GR | SIMED | E | N | 25/05/2021 |
17 | LIOREFEN | BACLOFENE | 10 mg | Comprimé sécable | B/100 | PHARMACARE | I | N | 28/05/2021 |
18 | SPIRAMIZOLE | METRONIDAZOLE+SPIRAMYCINE | 1.5 MUI/250 MG | Comprimé pelliculé | B/10 | GALPHARMA | E | N | 28/05/2021 |
19 | TEMO | TÉMOZOLOMIDE | 5 mg | Gélule | B/5 | LINO PHARMA | E | N | 28/05/2021 |
20 | TEMO | TÉMOZOLOMIDE | 20 mg | Gélule | B/5 | LINO PHARMA | E | N | 28/05/2021 |
21 | TEMO | TÉMOZOLOMIDE | 250 mg | Gélule | B/5 | LINO PHARMA | E | N | 28/05/2021 |
22 | TEMO | TÉMOZOLOMIDE | 100 MG | Gélule | B/5 | LINO PHARMA | E | N | 28/05/2021 |