Dossiers d'AMM à étudier par le Comité Technique des Spécialités Pharmaceutiques du 25/01/2023.
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 | CLARID | CLARITHROMYCINE | 500 mg | Comprimé pelliculé | B/28 | ADWYA | E | N | 06/01/2023 |
* Audit médicaments fabriqués localement (2ème passage)
N° | Médicament | DCI | Dosage | Forme Pharmaceutique | Présentation | TITULAIRE | VEIC | Type de demande | DATE Rapport |
1 | TELMYCOR-AM | TELMISARTAN+ AMLODIPINE | 40 mg/5 mg | comprimé | B/30 | THERA | E | N | 02/12/2022 |
2 | TELMYCOR-AM | TELMISARTAN+ AMLODIPINE | 80 mg/5 mg | comprimé | B/30 | THERA | E | N | 02/12/2022 |
3 | TELMYCOR-AM | TELMISARTAN+ AMLODIPINE | 40 mg/10 mg | comprimé | B/30 | THERA | E | N | 02/12/2022 |
4 | TELMYCOR-AM | TELMISARTAN+ AMLODIPINE | 80 mg/10 mg | comprimé | B/30 | THERA | E | N | 02/12/2022 |
* 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 | BRIMOTIM | BRIMONIDINE/ TIMOLOL | 0,2%/0,5% | collyre | FL/5 ML | ADWYA | E | N | 30/12/2022 |
2 | HEPARINE MEDIS | HEPARINE SODIQUE | 25000 UI/5ML | solution injectable | B/10FL/5ML | MEDIS | E | V | 30/12/2022 |
3 | LEVET | LEVETIRACETAM | 250 MG | comprimé pelliculé | B/60 | PHILADELPHIA PHARMA | E | N | 30/12/2022 |
4 | LEVET | LEVETIRACETAM | 750 MG | comprimé pelliculé | B/60 | PHILADELPHIA PHARMA | E | N | 30/12/2022 |
5 | LORISTA | LOSARTAN | 50 MG | comprimé pelliculé | B/30 | TAHA PHARMA | E | N | 30/12/2022 |
6 | LORISTA | LOSARTAN | 50 MG | comprimé pelliculé | B/90 | TAHA PHARMA | E | N | 30/12/2022 |
7 | LORISTA | LOSARTAN | 100 MG | comprimé pelliculé | B/30 | TAHA PHARMA | E | N | 30/12/2022 |
8 | LORISTA | LOSARTAN | 100 MG | comprimé pelliculé | B/90 | TAHA PHARMA | E | N | 30/12/2022 |
9 | SUNITINIB NEAPOLIS | SUNITINIB | 12,5 MG | gélule | B/28 | NEAPOLIS PHARMA | V | N | 30/12/2022 |
10 | THERAFENIB | SORAFENIB | 200 MG | comprimé pelliculé | B/60 | THERA | V | N | 30/12/2022 |
11 | ANTIOMAL | LEVETIRACETAM | 1000 MG | comprimé pelliculé sécable | B/30 | TAHA PHARMA | E | N | 03/01/2023 |
12 | CVL PLUS | ACIDESALICYLIQUE COLLODION | 12,5 g/100g | solution externe | FL/5 ML | PHARMAGHREB | C | N | 03/01/2023 |
13 | ERLUS | DESLORATADINE | 5 MG | Comprimé pelliculé | B/30 | SAIPH | E | N | 03/01/2023 |
14 | ERLUS | DESLORATADINE | 5 MG | Comprimé pelliculé | B/15 | SAIPH | E | N | 03/01/2023 |
15 | ROCOR | ROSUVASTATINE CALCIUM | 5 MG | Comprimé pelliculé | B/30 | PHARMACARE | E | N | 03/01/2023 |
16 | COMBICOL | BRIMONIDINE/ TIMOLOL | 2 MG/ML | Solution ophtalmologique | B/30 unidoses | UNIMED | E | N | 05/01/2023 |
17 | SACUVAL 50 | SACUBITRIL +VALSARTAN | 24,3 MG/25,7 MG | Comprimé pelliculé | B/30 | PHILADELPHIA PHARMA | E | N | 05/01/2023 |
18 | SACUVAL 100 | SACUBITRIL +VALSARTAN | 48,6MG/51,4 MG | Comprimé pelliculé | B/60 | PHILADELPHIA PHARMA | E | N | 05/01/2023 |
19 | SACUVAL 200 | SACUBITRIL +VALSARTAN | 97,2 MG/102,8 MG | Comprimé pelliculé | B/60 | PHILADELPHIA PHARMA | E | N | 05/01/2023 |
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 | IMMUNOGLOBULINE HUMAINE POLYVALENTE | 10G/10ML | SOL INJ PR PRF | FL/100 ML | BIOTEST PHARMA GMBH | E | V | CS 10/01/2023 |
43 | DARZALEX | DARATUMUMAB | 20MG/ML | SOL A DIL PR PRF | B/1FL/5ML | Janssen-Cilag International N.V | V | CS 10/01/2023 | |
44 | DARZALEX | DARATUMUMAB | 40MG/ML | SOL A DIL PR PRF | B/1FL/20ML | Janssen-Cilag International N.V | V | CS 10/01/2023 | |
45 | Pemzek PLUS | Candesartan+Hydrochlorothiazide | 8 mg/12.5 MG | comprimé | B/28 | ASTRA ZENECA SUISSE | E | V | CS 31/01/2023 |
46 | Pemzek PLUS | Candesartan+Hydrochlorothiazide | 16 mg/12.5 MG | comprimé | B/28 | ASTRA ZENECA SUISSE | E | V | CS 31/01/2023 |
47 | Jardiance | empagliflozine | 10 mg | comprimé | B/30 | Boehringer Ingelhei Allemagne | E | V | CS 31/01/2023 |
48 | Jardiance | empagliflozine | 25 mg | comprimé | B/30 | Boehringer Ingelhei Allemagne | E | V | CS 31/01/2023 |
49 | ROPIVACAINE KABI | ROPIVACAINE | 5 mg/ml, | solution injectable en ampoule. | B/5 | FRESINUS KABI | E | V | CS 31/01/2023 |
50 | ROPIVACAINE KABI | ROPIVACAINE | 7,5 mg/ml, | solution injectable en ampoule. | B/5 | FRESINUS KABI | E | V | CS 31/01/2023 |