Dossiers d'AMM à étudier par le Comité Technique des Spécialités Pharmaceutiques du 16/02/2023.
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 Rapport |
1 | THERAFENIB | SORAFENIB | 200 MG | comprimé pelliculé | B/60 | THERA | V | N | 01/02/2023 |
2 | DAFLON | DIOSMINE+ HESPERIDINE | 1000 mg | Comprimé pelliculé | B/30 | TERIAK | C | N | 03/02/2023 |
3 | SACUVAL 50 | SACUBITRIL +VALSARTAN | 24,3 MG/25,7 MG | Comprimé pelliculé | B/30 | PHILADELPHIA PHARMA | E | N | 05/01/2023 |
4 | SACUVAL 100 | SACUBITRIL +VALSARTAN | 48,6MG/51,4 MG | Comprimé pelliculé | B/60 | PHILADELPHIA PHARMA | E | N | 05/01/2023 |
5 | SACUVAL 200 | SACUBITRIL +VALSARTAN | 97,2 MG/102,8 MG | Comprimé pelliculé | B/60 | PHILADELPHIA PHARMA | E | N | 05/01/2023 |
* 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 | DEBRICOL | TRIMEBUTINE | 74,4 mg | Granulés pour suspension buvable | B/16 sachets | GALPHARMA | I | N | 18/01/2023 |
2 | MUCOLYSE | ACETYLCYSTEINE | 200 mg | Poudre pour sol orale | B/18 sachets | GALPHARMA | C | N | 18/01/2023 |
3 | CALMINE | LIDOCAINE+ PRILOCAINE | 2,5%/2,5% | CREME DERMIQUE | T/30 G | GALPHARMA | E | N | 24/01/2023 |
4 | CHLORURE DE SODIUM | CHLORURE DE SODIUM | 0,1 | solution injectable | B/10/10ML | UNIMED | V | V | 31/01/2023 |
5 | CHLORURE DE SODIUM | CHLORURE DE SODIUM | 0,1 | solution injectable | B/100/10ML | UNIMED | V | V | 31/01/2023 |
6 | CLOVEN | CLOPIDOGREL | 75mg | Comprimé pelliculé | B/30 | Philadelphia Pharma | E | V | 31/01/2023 |
7 | CLOVEN | CLOPIDOGREL | 75mg | Comprimé pelliculé | B/90 | Philadelphia Pharma | E | V | 31/01/2023 |
8 | CORTIS | BECLOMETHASONE DIPROPIONATE | 100µg/dose | sol pr inhalation | FL/ 100 doses | Berg Life Sciences | E | V | 31/01/2023 |
9 | ENAPRIL | ENALAPRIL | 5 MG | Comprimé sécable | B/28 | ADWYA | E | V | 31/01/2023 |
10 | ENAPRIL | ENALAPRIL | 20 MG | Comprimé sécable | B/28 | ADWYA | E | V | 31/01/2023 |
11 | EVOCOR | BISOPROLOL | 2.5 MG | Comprimé pelliculé | B/30 | Philadelphia Pharma | E | V | 31/01/2023 |
12 | EVOCOR | BISOPROLOL | 2.5 MG | Comprimé pelliculé | B/90 | Philadelphia Pharma | E | V | 31/01/2023 |
13 | EVOCOR | BISOPROLOL | 5MG | Comprimé pelliculé | B/30 | Philadelphia Pharma | E | V | 31/01/2023 |
14 | EVOCOR | BISOPROLOL | 5 MG | Comprimé pelliculé | B/90 | Philadelphia Pharma | E | V | 31/01/2023 |
15 | EVOCOR | BISOPROLOL | 10MG | Comprimé pelliculé | B/30 | Philadelphia Pharma | E | V | 31/01/2023 |
16 | EVOCOR | BISOPROLOL | 10MG | Comprimé pelliculé | B/90 | Philadelphia Pharma | E | V | 31/01/2023 |
17 | EZEMIB | EZETIMIBE | 10mg | Comprimé | B/30 | THERA | E | V | 31/01/2023 |
18 | LIDOCA | LIDOCAINE | 10 mg/ml | solution injectable | B/10 AMP | STERIPHARM | E | T | 31/01/2023 |
19 | LIDOCA | LIDOCAINE | 20 mg/ml | solution injectable | B/10 AMP | STERIPHARM | E | T | 31/01/2023 |
20 | UNICAINE | CHLORHYDRATE DE LIDOCAINE | 0,01 | solution injectable | B/10 AMP | UNIMED | E | V | 31/01/2023 |
21 | UNICAINE | CHLORHYDRATE DE LIDOCAINE | 0,02 | solution injectable | B/10 AMP | UNIMED | E | V | 31/01/2023 |
22 | CLARIREC | CLARITHROMYCINE | 500 mg | Comprimé pelliculé | B/14 | OPALIA PHARMA | E | N | 14/02/2023 |
23 | CLAVUMOX ENFANT | AMOXICILLINE TRIHYDRATE/ ACIDE CLAVULANIQUE | 500 mg/62,5 mg | Poudre pour suspension buvable | B/24 Sachets | GALPHARMA | E | N | 14/02/2023 |
24 | FLUJECT | FLUCONAZOLE | 2 mg/ml | Solution pour perfusion | P/ 50 ml | UNIMED | E | N | 14/02/2023 |
25 | FLUJECT | FLUCONAZOLE | 2 mg/ml | Solution pour perfusion | P/ 100 ml | UNIMED | E | N | 14/02/2023 |
26 | FLUJECT | FLUCONAZOLE | 2 mg/ml | Solution pour perfusion | P/ 200 ml | UNIMED | E | N | 14/02/2023 |
27 | COLOCALM INJECT | PHLOROGLUCINOL DIHYDRATE/ TRIMETHYLPHLOROGLUCINOL | 40 mg | solution injectable | B/6 AMP | STERIPHARM | I | N | 14/02/2023 |
28 | COVISTOP | PHENIRAMINE MALEATE/ CHLORURE DE BENZALKONIUM | 270/36 µg/actuation | solution nasale | FL/15 ml | LES LABORATOIRES MEDIS | N | 14/02/2023 | |
29 | DASATINIB NEAPOLIS | DASATINIB MONOHYDRATE | 100 mg | Comprimé pelliculé | B/ 30 | NEAPOLIS PHARMA | E | N | 14/02/2023 |
30 | MIRAZINE | MIRTAZAPINE | 15 mg | Comprimé pelliculé sécable | B/ 30 | SAIPH | E | N | 14/02/2023 |
31 | MIRAZINE | MIRTAZAPINE | 30 mg | Comprimé pelliculé sécable | B/ 30 | SAIPH | E | N | 14/02/2023 |
32 | ZETOREC | EZETIMIB/ ATORVASTATINE | 10 mg/10 mg | Comprimé pelliculé | B/ 30 | OPALIA PHARMA | E | N | 14/02/2023 |
33 | CLAVUMOX | AMOXICILLINE TRIHYDRATE/ ACIDE CLAVULANIQUE | 100 mg/12,5 mg | Poudre pour suspension buvable | FL/30 ML | GALPHARMA | E | N | 15/02/2023 |
34 | CLAVUMOX | AMOXICILLINE TRIHYDRATE/ ACIDE CLAVULANIQUE | 100 mg/12,5 mg | Poudre pour suspension buvable | FL/60 ML | GALPHARMA | E | N | 15/02/2023 |
35 | CLAVUMOX | AMOXICILLINE TRIHYDRATE/ ACIDE CLAVULANIQUE | 500 mg/62,5 mg | comprimé pelliculé | B/16 | GALPHARMA | E | N | 15/02/2023 |
36 | CLAVUMOX | AMOXICILLINE TRIHYDRATE/ ACIDE CLAVULANIQUE | 500 mg/62,5 mg | comprimé pelliculé | B/24 | GALPHARMA | E | N | 15/02/2023 |
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 | HUMIRA | ADALIMUMAB | 80 mg/0.8 ml | SOL INJ | B/1 stylo pré-rempli/0.8 ml | ABBVIE DEUTSCHLAND Gmbh and Co.KG | E | N | 05/09/2022 |
2 | HUMIRA | ADALIMUMAB | 40 mg/0.4ml | SOL INJ | B/2 stylo pré-rempli/0.4 ml | ABBVIE DEUTSCHLAND Gmbh and Co.KG | E | N | 05/09/2022 |
3 | HUMIRA | ADALIMUMAB | 20 mg/0.2 ml | SOL INJ | B/1 seringue pré-rempli/0.2ml | ABBVIE DEUTSCHLAND Gmbh and Co.KG | E | N | 05/09/2022 |
4 | DUOPLAVIN | CLOPIDOGREL+ ACIDE ACETYLSALICYLIQUE | 75 mg/100 mg | Comprimé pelliculé | B/28 | SANOFI PHARMA B.M.S SNC | E | N | 02/11/2022 |
5 | ERBITUX 100 | CETUXIMAB | 5 mg/ml | SOL INJ PR PERF | B/1 Flacon/20 ml | MERCK EUROPE B.V | V | T | 09/11/2022 |
6 | ERBITUX 500 | CETUXIMAB | 5 mg/ml | SOL INJ PR PERF | B/1 Flacon/100 ml | MERCK EUROPE B.V | V | T | 09/11/2022 |
7 | DEXMEDETOMIDINE EVER PHARMA | Dexmedetomidine | 200µg/2ml (100µg/ml) | SOL INJ PR PERF | B/5FL/2ML | EVER Valinject GmbH | N | 16/11/2022 | |
8 | DEXMEDETOMIDINE EVER PHARMA | Dexmedetomidine | 400µg/4ml (100µg/ml) | SOL INJ PR PERF | B/5FL/4ML | EVER Valinject GmbH | N | 16/11/2022 | |
9 | DEXMEDETOMIDINE EVER PHARMA | Dexmedetomidine | 1000µg/10ml (100µg/ml) | SOL INJ PR PERF | B/5FL/10ML | EVER Valinject GmbH | N | 16/11/2022 | |
10 | HEBERPROT-P 75 | FACTEUR DE CROISSANCE EPIDERMIQUE RECOMBINANT | 75 mcg | PDRE PR PREP INJ | B/6 flacons | CIGB CUBA | E | N | 09/11/2022 |
11 | FIXAPROST | LATANOPROST+TIMOLOL | 50 µg/ml | COLLYRE | B/30 unidoses | THEA | E | N | 29/11/2022 |
12 | SKYRIZI | RISANKIZUMAB | 75 mg | SOL INJ | B/2 | ABBVIE DEUTSCHLAND Gmbh and Co.KG | N | 05/12/2022 | |
13 | UPTRAVI | SELEXIPAG | 200µG | COMP PEL | B/140 | Janssen-Cilag International N.V | V | N | 06/12/2022 |
14 | UPTRAVI | SELEXIPAG | 200µG | COMP PEL | B/60 | Janssen-Cilag International N.V | V | N | 06/12/2022 |
15 | UPTRAVI | SELEXIPAG | 400µG | COMP PEL | B/60 | Janssen-Cilag International N.V | V | N | 06/12/2022 |
16 | UPTRAVI | SELEXIPAG | 600µG | COMP PEL | B/60 | Janssen-Cilag International N.V | V | N | 06/12/2022 |
17 | UPTRAVI | SELEXIPAG | 800µG | COMP PEL | B/60 | Janssen-Cilag International N.V | V | N | 06/12/2022 |
18 | UPTRAVI | SELEXIPAG | 1000µG | COMP PEL | B/60 | Janssen-Cilag International N.V | V | N | 06/12/2022 |
19 | UPTRAVI | SELEXIPAG | 1200µG | COMP PEL | B/60 | Janssen-Cilag International N.V | V | N | 06/12/2022 |
20 | UPTRAVI | SELEXIPAG | 1400µG | COMP PEL | B/60 | Janssen-Cilag International N.V | V | N | 06/12/2022 |
21 | UPTRAVI | SELEXIPAG | 1600µG | COMP PEL | B/60 | Janssen-Cilag International N.V | V | N | 44901 |
22 | OPSUMIT | MACITENTAN | 10 mg | COMP PEL | B/30 | Janssen-Cilag International N.V | N | 44901 | |
23 | VICTOZA | Liraglutide | 6mg/ml | SOL INJ | B/2 | NOVO-NORDISK DANEMARK | V | 08/12/2022 | |
24 | FORXIGA | DAPAGLIFLOZINE | 5 MG | COMP PEL | B/28 | ASTRA ZENECA | E | V | 21/12/2022 |
25 | FORXIGA | DAPAGLIFLOZINE | 10 MG | COMP PEL | B/28 | ASTRA ZENECA | E | V | 21/12/2022 |
26 | XELJANZ XR | TOFACITINIB | 11 MG | COMP PEL | B/30 | Pfizer INC USA | N | 30/12/2022 | |
27 | ZYDEX HC | ACIDE FUSIDIQUE+HYDROCORTISONE | 2%-1% | CREM DERMIQUE | T/15G | BEIT JALA PALESTINE | E | N | 02/01/2023 |
28 | ZEFFIX | LAMIVUDINE | 100 MG | COMP PEL | B/28 | GSK IRELAND | E | T | 01/02/2023 |
* 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 | NEURONTIN | GABAPENTINE | 600 mg | COMP PEL SEC | B/50 | PFIZER OFG GERMANY GMBH | V | T | 21/01/2022 |
2 | POVIDEX | POVIDONE IODEE | 5% | SUP VAGINAL | B/12 | BEIT JALA Pharmaceutical Co | I | N | 21/09/2022 |
3 | LIPERCOSYL | ATORVASTATINE+PERINDOPRIL ARGININE | 40 MG/ 5MG | Gélule | B/30 | SERVIER | E | N | 21/09/2022 |
4 | LIPERCOSYL | ATORVASTATINE+PERINDOPRIL ARGININE | 20 MG/ 5MG | Gélule | B/30 | SERVIER | E | N | 21/09/2022 |
5 | LIPERCOSYL | ATORVASTATINE+PERINDOPRIL ARGININE | 10 MG/ 5MG | Gélule | B/30 | SERVIER | E | N | 21/09/2022 |
6 | LIPERCOSYL | ATORVASTATINE+PERINDOPRIL ARGININE | 40 MG/ 10MG | Gélule | B/30 | SERVIER | E | N | 21/09/2022 |
7 | LIPERCOSYL | ATORVASTATINE+PERINDOPRIL ARGININE | 20 MG/ 10MG | Gélule | B/30 | SERVIER | E | N | 21/09/2022 |
8 | LIPERCOSYL | ATORVASTATINE+PERINDOPRIL ARGININE | 10MG/10MG | ||||||
9 | VYZULTA | LATANOPTOSTENE BUNOD | 0.024% | COLLYRE | B/1FL | Baush & Lomb, Incorporated | N | 28/09/2022 | |
10 | TENORETIC | ATENOLOL+CHLORTALIDONE | 50mg/12.5mg | COMP PEL | B/30 | ATNAHS PHARMA NETHERLANDS B.V | E | T | 30/09/2022 |
11 | DEPAMIDE | VALPROMIDE | 300 MG | COMP PEL | B/30 | SANOFI AVENTIS France | V | V | CS 05/10/2022 |
12 | LUMIGAN | BIMATOPROST | 0.1 mg/ml | COLLYRE | B/1FL | ABBVIE DEUTSCHLAND Gmbh and Co.KG | E | N | 14/10/2022 |
13 | GANFORT | BIMATOPROST+TIMOLOL | 0.3MG/ML+5MG/ML | COLLYRE | B/1/3ML | ABBVIE DEUTSCHLAND Gmbh and Co.KG | E | T | 19/10/2022 |
14 | HELMINTOX | PYRANTEL | 250 mg | Cp Pell Sécable | B/3 | INNOTECH INTERNATIONAL | v | 311/10/2022 | |
15 | ISOSUPRA LIDOSE | ISOTRETINOINE | 8 MG | GELULLE | B/30 | SMB S.A | I | N | 04/11/2022 |
16 | OZURDEX | DEXAMETHASONE | 700 mcg | implant intravitréen | B/ 1 implant intravitréen | ABBVIE DEUTSCHLAND Gmbh and Co.KG | E | T | 08/11/2022 |
17 | ATOSIBAN EVER Pharma | ATOSIBAN | 37.5 mg/ 5 ml | SOL INJ PR PRF | B/1 flacon / 5ml | EVER Valinject GmbH | E | N | 16/11/2022 |
18 | ATOSIBAN EVER Pharma | ATOSIBAN | 75 mg/ 10 ml | SOL INJ PR PRF | B/1 flacon / 10ml | EVER Valinject GmbH | E | N | 16/11/2022 |
19 | ATOSIBAN EVER Pharma | ATOSIBAN | 6,75 mg/ 0,9 ml | SOL INJ PR PRF | B/1 flacon / 2 ml | EVER Valinject GmbH | E | N | 16/11/2022 |
20 | MYCOTEN VAGINAL CREAM | CLOTRIMAZOLE | 2% | CREME VAGINAL | T/20g | BEIT JALA Pharmaceutical Co | I | N | 16/11/2022 |
21 | MYCOTEN | CLOTRIMAZOLE | 500 mg | COMP VAGINAL | B/1 + Applicateur | BEIT JALA Pharmaceutical Co | E | N | 16/11/2022 |
22 | MYCOTEN | CLOTRIMAZOLE | 200 mg | COMP VAGINAL | B/3 + Applicateur | BEIT JALA Pharmaceutical Co | E | N | 16/11/2022 |
23 | PENTASA | MESALAZINE | 1 g | SUPPO | B/28 | FERRING GmbH | E | N | 28/11/2022 |
24 | LOXEN | NICARDIPINE | 20 MG | COMP SECABLE | B/30 | CARDIXO | E | T | 13/12/2022 |
25 | ALPHAGAN | TARTRATE DE BRIMONIDE | 2MG/ML | COLLYRE | FL/ML | ABBVIE BV VLOG NETHERLAND | T | 22/12/2022 | |
26 | HEALER CREME | MAFENIDE ACETATE | 8.5% | CREME DERMIQUE | T/15 gr | BEIT JALA Pharmaceutical Co | C | N | 05/01/2023 |
27 | KALINOR - retard P | CHLORURE DE POTASSIUM | 600 mg | GELULLE | B/50 | DESMA GmbH | T | 05/01/2023 | |
28 | IMBRUVICA | IBRUTINIB | 560 mg | COM PEL | B/30 | Janssen-Cilag International N.V | E | N | 05/01/2023 |
29 | IMBRUVICA | IBRUTINIB | 420 mg | COM PEL | B/30 | Janssen-Cilag International N.V | E | N | 05/01/2023 |
30 | IMBRUVICA | IBRUTINIB | 280 mg | COM PEL | B/30 | Janssen-Cilag International N.V | E | N | 05/01/2023 |
31 | IMBRUVICA | IBRUTINIB | 140 mg | COM PEL | B/30 | Janssen-Cilag International N.V | E | N | 05/01/2023 |
32 | VENCLYXTO | VENETOCLAX | 10 mg | COM PEL | B/7 | ABBVIE DEUTSCHLAND GmbH & Co,KG | V | CS 10/01/2023 | |
33 | VENCLYXTO | VENETOCLAX | 50 mg | COM PEL | B/7 | ABBVIE DEUTSCHLAND GmbH & Co,KG | V | CS 10/01/2023 | |
34 | VENCLYXTO | VENETOCLAX | 100 mg | COM PEL | B/7 | ABBVIE DEUTSCHLAND GmbH & Co,KG | V | CS 10/01/2023 | |
35 | VENCLYXTO | VENETOCLAX | 100 mg | COM PEL | B/14 | ABBVIE DEUTSCHLAND GmbH & Co,KG | V | CS 10/01/2023 | |
36 | VENCLYXTO | VENETOCLAX | 100 mg | COM PEL | B/112 | ABBVIE DEUTSCHLAND GmbH & Co,KG | V | CS 10/01/2023 | |
37 | JAKAVI | RUXOLITINIB | 15 mg | COMPRIME | B/56 | NOVARTIS PHARMA SCHWEIZ AG | E | V | CS 10/01/2023 |
38 | JAKAVI | RUXOLITINIB | 20 mg | COMPRIME | B/56 | NOVARTIS PHARMA SCHWEIZ AG | E | V | CS 10/01/2023 |
39 | JAKAVI | RUXOLITINIB | 5 mg | COMPRIME | B/56 | NOVARTIS PHARMA SCHWEIZ AG | E | V | CS 10/01/2023 |
40 | INTRATECT | IMMUNOGLOBULINE HUMAINE POLYVALENTE | 10G/200ML | SOL INJ PR PRF | FL/200 ML | BIOTEST PHARMA GMBH | E | V | CS 10/01/2023 |
41 | INTRATECT | IMMUNOGLOBULINE HUMAINE POLYVALENTE | 5G/50ML | SOL INJ PR PRF | FL/50 ML | BIOTEST PHARMA GMBH | E | V | CS 10/01/2023 |
42 | INTRATECT | 10G/10ML | SOL INJ PR PRF | FL/100 ML | BIOTEST PHARMA GMBH | E | V | CS 10/01/2023 | |
43 | SINGULAIR | MONTELUKAST | 4 MG | GRANULES | B/28 | ORGANON BV | T | 18/01/2023 | |
44 | Pemzek | Candesartan | 8 mg | comprimé | B/28 | ASTRA ZENECA SUISSE | E | T | CS 31/01/2023 |
45 | Pemzek | Candesartan | 16 mg | comprimé | B/28 | ASTRA ZENECA SUISSE | E | T | CS 31/01/2023 |
46 | Pemzek PLUS | Candesartan | 8 mg/12.5 MG | comprimé | B/28 | ASTRA ZENECA SUISSE | E | V | CS 31/01/2023 |
47 | Pemzek PLUS | Candesartan+Hydrochlorothiazide | 16 mg/12.5 MG | comprimé | B/28 | ASTRA ZENECA SUISSE | E | V | CS 31/01/2023 |
48 | Jardiance | empagliflozine | 10 mg | comprimé | B/30 | Boehringer Ingelhei Allemagne | E | V | CS 31/01/2023 |
49 | Jardiance | empagliflozine | 25 mg | comprimé | B/30 | Boehringer Ingelhei Allemagne | E | V | CS 31/01/2023 |
50 | ROPIVACAINE KABI | ROPIVACAINE | 5 mg/ml, | solution injectable en ampoule. | B/5 | FRESINUS KABI | E | V | CS 31/01/2023 |
51 | ROPIVACAINE KABI | ROPIVACAINE | 7,5 mg/ml, | solution injectable en ampoule. | B/5 | FRESINUS KABI | E | V | CS 31/01/2023 |
52 | HALAVEN | MESILATE D'ERIBULINE | 0.44 mg/ml | SOL INJ | Fl/2ml | Eisai Europe Limited | V | N | 08/02/2023 |
53 | PYLERA | BISMUTH +METRONIDAZOLE+TETRACYCLINE | 140mg/125mg/125mg | GELULLE | B/120 Gélule | Allergan Sales LLC | E | T | 08/02/2023 |
54 | ENSPRYNG | SATRALIZUMAB | 120 mg/1 ml | SERINGUE | B/1 | Roche Pharma (Schweiz) AG | N | 14/02/2023 | |
55 | RIXATHON | RITUXIMAB | 100 mg | SOL A DIL PR PRF | B/2 FL/10ml | SANDOZ GmbH | V | N | 14/02/2023 |
56 | RIXATHON | RITUXIMAB | 500 mg | SOL A DIL PR PRF | B/2 FL/50ml | SANDOZ GmbH | V | N | 14/02/2023 |