Dossiers d'AMM à étudier par le Comité Technique des Spécialités Pharmaceutiques du 07/04/2021.
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 | PSORIASONE | CALCIPOTRIOL+BETAMETHASONE | 50 mcg/0.5mg/gr | Pommade dermique | B/2T/60 gr | OPALIA PHARMA | E | N | 08/03/2021 |
2 | SURANIL | HYDROCORTISONE | 10 MG | Comprimé | B/60 | ACT PHARMA | E | N | 10/03/2021 |
3 | ZELID 500 | CLARITHROMYCINE | 500 mg | Comprimé pelliculé | B/28 | SAIPH | E | N | 12/03/2021 |
4 | DUOFOR PLUS | AMLODIPINE+VALSARTAN+HYDROCHLOROTHIAZIDE | 10 mg/160mg/25mg | Comprimé pelliculé | B/30 | PHILADELPHIA PHARMA | E | N | 22/03/2021 |
5 | NAZOPRAY | FLUTICASONE | 50 µg | Solution pour pulverisation na | FL/120 Doses | BERG LIFE SCIENCES | E | N | 23/03/2021 |
6 | RIABAL | PRIFINIUM | 30 mg | Comprimé pelliculé | B/20 | IBN AL BAYTAR | I | N | 23/03/2021 |
7 | RIABAL COMPOUND | PRIFINIUM | 30 mg + 325 mg | Comprimé pelliculé | B/20 | IBN AL BAYTAR | I | N | 23/03/2021 |
8 | BICLAVOR | AMOXICILLINE+ACIDE CLAVULANIQUE | 500 mg/62.5 mg | Comprimé pelliculé | B/48 | SAIPH | E | N | 26/03/2021 |
9 | ROCOR10 | ROSUVASTATINE | 10 mg | Comprimé pelliculé | B/30 | PHARMACARE | E | N | 31/03/2021 |
10 | ROCOR20 | ROSUVASTATINE | 20 mg | Comprimé pelliculé | B/30 | PHARMACARE | E | N | 31/03/2021 |
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 | 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 | 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 | T | 17/02/2021 | |
21 | HEMLIBRA | EMICIZUMAB | 30mg/ml | SOL INJ | B/1FL/1ML | Roche Pharma (Schweiz) AG | N | 24/03/2021 | |
22 | HEMLIBRA | EMICIZUMAB | 150mg/ml | SOL INJ | B/1FL/1ML | Roche Pharma (Schweiz) AG | N | 24/03/2021 | |
23 | HEMLIBRA | EMICIZUMAB | 105 mg / 0,7ml | SOL INJ | B/1FL/3ML | Roche Pharma (Schweiz) AG | N | 24/03/2021 | |
24 | HEMLIBRA | EMICIZUMAB | 60 mg / 0,4ml | SOL INJ | B/1FL/3ML | Roche Pharma (Schweiz) AG | N | 24/03/2021 |
* 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 | IMBRUVICA | IBRUTINIB | 140 MG | GELULES | B/90 | JANSSEN-CILAG | E | V | 15/12/2020 |
2 | CUREAML | HYDROXYCARBAMIDE | 500 MG | GELULES | B/30 | HIKMA PHARMACEUTICAL JORDANI | V | V | 15/12/2020 |
3 | PROTHROMPLEX | FACTEUR IX II VII X | 600 I,U, | poudre et solvant pour préparation injectable | B/1FL+S/20ML | BAXTER AG | V | V | 15/12/2020 |
4 | PLAVIX | CLOPIDOGREL | 300 MG | COMPRIME PELLICULE | B/4 | SANOFI CLIR SNC France | E | V | 22/12/2020 |
5 | FRAXIPARINE | NADROPARINE CALCIQUE | 3800 UI | SOLUTION INJECTABLE | B/10/0,4ML SERINGUES PRE-REMPLIE | ASPEN PHARMA TRADING LIMITED | E | V | 22/12/2020 |
6 | FRAXIPARINE | NADROPARINE CALCIQUE | 2850 UI | SOLUTION INJECTABLE | B/10 /0,3ML SERINGUES PRE-REMPLIE | ASPEN PHARMA TRADING LIMITED | E | V | 22/12/2020 |
7 | OFEV | NINTEDANIB | 150 MG | CAPSULE MOLLE | B/60 | BOEHRINGER INGELHEIM INTERNATIONAL | I | V | 22/12/2020 |
8 | OFEV | NINTEDANIB | 100 MG | CAPSULE MOLLE | B/60 | BOEHRINGER INGELHEIM INTERNATIONAL | I | V | 22/12/2020 |
9 | VISANNE | DIENOGEST | 2MG | COMPRIME | B/28 | JENAPHARM GMBH& CO,KG | E | T | 22/12/2020 |
10 | SEROQUEL XL | QUETIAPINE FUMARATE | 300 MG | COMPRIME A LIBERATION PROLONG | B/60 | ASTRAZENECA UL,LTD | E | V | 29/12/2020 |
11 | SEROQUEL XL | QUETIAPINE FUMARATE | 400 MG | COMPRIME A LIBERATION PROLONG | B/60 | ASTRAZENECA UL,LTD | E | V | 29/12/2020 |
12 | SEROQUEL XL | QUETIAPINE FUMARATE | 200 MG | COMPRIME A LIBERATION PROLONG | B/60 | ASTRAZENECA UL,LTD | E | V | 29/12/2020 |
13 | SEROQUEL XL | QUETIAPINE FUMARATE | 50 MG | COMPRIME A LIBERATION PROLONG | B/60 | ASTRAZENECA UL,LTD | E | V | 29/12/2020 |
14 | KIOVIG | IMMUNOGLOBULINE HUMAINE NORMALE | 100 MG/ML | SOLUTION INJECTABLE POU PERFUSION | FL/25ML | BAXTER AG | E | V | 29/12/2020 |
15 | KIOVIG | IMMUNOGLOBULINE HUMAINE NORMALE | 100 MG/ML | SOLUTION INJECTABLE POU PERFUSION | FL/50 ML | BAXTER AG | E | V | 29/12/2020 |
16 | AKLONIL | CLONAZEPAM | 2 MG | COMPRIME SECABLE | B/40 | MEDOCHEMIE LTD | V | V | 29/12/2020 |
17 | INTRATECT | IMMUNOGLOBULINE HUMAINE POLYVALENTE | 5G/100ML | SOLUTION INJECTABLE POU PERFUSION | FL/100ML | BIOTEST PHARMA GMBH | E | V | 29/12/2020 |
18 | INTRATECT | IMMUNOGLOBULINE HUMAINE POLYVALENTE | 2,5G/50ML | SOLUTION INJECTABLE POU PERFUSION | FL/50ML | BIOTEST PHARMA GMBH | E | V | 29/12/2020 |
19 | LEVOTHYROX | LEVOTHYROXINE SODIQUE | 25 µg | COMPRIME SECABLE | B/30 | MERCK SANTE S,A,S/France | C | V | 29/12/2020 |
20 | LEVOTHYROX | LEVOTHYROXINE SODIQUE | 50 µg | COMPRIME SECABLE | B/30 | MERCK SANTE S,A,S/France | C | V | 29/12/2020 |
21 | LEVOTHYROX | LEVOTHYROXINE SODIQUE | 100 µg | COMPRIME SECABLE | B/30 | MERCK SANTE S,A,S/France | C | V | 29/12/2020 |
22 | LEVOTHYROX | LEVOTHYROXINE SODIQUE | 125 µg | COMPRIME SECABLE | B/30 | MERCK SANTE S,A,S/France | C | V | 29/12/2020 |
23 | LEVOTHYROX | LEVOTHYROXINE SODIQUE | 75 µg | COMPRIME SECABLE | B/30 | MERCK SANTE S,A,S/France | C | V | 29/12/2020 |
24 | MEGASFON | PHLOROGLUCINOL/ TRIMETHYL PHLOROGLUCINOL | 150 MG /150MG | SUPPOSITOIRE | B/08 | PHARMA 5 /MAROC | I | N | 29/12/2020 |
25 | CORYZALIA | SOLUTION BUVABLE | B/20 UNIDOSES DE 1ML | BOIRON | C | N | 11/01/2021 | ||
26 | ANGIPAX | COMPRIME ORODISPERSIBLE | B/40 | LEHNING France | N | 11/01/2021 | |||
27 | LOXEN LP | NICARDIPINE | 50 MG | GELULES | B/60 | CARDIXO- France | E | T | 11/01/2021 |
28 | ZEFFIX | LAMIVUDINE | 100 MG | COMPRIME PELLICULE | B/28 | GLAXOSMITHKLINE (IRELAND) LIMITED | T | 11/01/2021 | |
29 | VICTOZA | LIRAGLUTIDE | 6 MG/ML | SOLUTION INJECTABLE | B/2 STYLOS DE 3ML | NOVO NORDISK A/S | V | V | 12/01/2021 |
30 | RHESONATIV | ANTI-D(RH) immunoglobuline | 625 IU/ML | SOLUTION INJECTABLE | B/1 AMP/2ML | OCTAPHARMA AB | E | V | 12/01/2021 |
31 | NEXIUM | ESOMEPRAZOLE | 40 MG | COMPRIME GASTRO-RESISTANT | B/28 | ASTRAZENECA UL,LTD | E | T | 12/01/2021 |
32 | POLYGYNAX | NEOMYCINE+ NYSTATINE+ POLYMYXINE B | CAPSULE VAGINALE | B/6 | INNOTECH INTERNATIONAL | I | V | 12/01/2021 | |
33 | NIMENRIX | VACCIN MENINGOCOCCIQUE CONJUGUE DES GROUPES A,C,W135 et Y | poudre et solvant pour solution injectable | B/1FL POUDRE + seringue pré-remplie de solvant | Pfizer Europe MA EEIG Belgique | I | T | 25/01/2021 | |
34 | DIOVENOR | DIOSMINE | 600 MG | COMPRIME PELLICULE | B/30 | INNOTHERA France | C | N | 25/01/2021 |
35 | FORLAX | POLYETHYLENE GLYCOL | 4G | POUDRE POUR SOLUTION ORALE | B/20 | IPSEN CONSUMER HEALTHCARE France | C | T | 25/01/2021 |
36 | NASOALDO | MOMETASONE FUROATE MONOHYDRATE | 50 µg | suspension pour pulvérisation nasale | F/140 DOSES | ALDO UNION S,L- Espagne | N | 05/02/2021 | |
37 | FORTACIN | LIDOCAINE + PRILOCAINE | 150 mg/ML + 50mg /ml | solution cutanée | FL/ 5ML | RECORDATI - IRELAND | N | 22/02/2021 | |
38 | GENEMENT | TADALAFIL | 20 mg | comprimé | B/4 | GENEPHARM S.A | C | N | 04/03/2021 |
39 | GENEMENT | TADALAFIL | 10 mg | comprimé | B/4 | GENEPHARM S.A | C | N | 04/03/2021 |
40 | ACETETE DE TERLIPRESSINE EVER PHARMA | TERLIPRESSINE | 0.2 mg/ml | SOL INJ | B/5 | EVER Valinject GmbH | E | N | 04/03/2021 |
41 | MONCAS | MONTELUKAST | 5 MG | COMP PEL | B/28 | GENEPHARM S.A | E | N | 25/03/2021 |
42 | MONCAS | MONTELUKAST | 10 MG | COMP PEL | B/28 | GENEPHARM S.A | E | N | 25/03/2021 |
43 | MONCAS | MONTELUKAST | 4 MG | COMP PEL | B/28 | GENEPHARM S.A | E | N | 25/03/2021 |
44 | VIAGRA | SILDENAFIL | 100 MG | COMP PEL | B/4 | Upjohn EESV | C | T | 26/03/2021 |
45 | VIAGRA | SILDENAFIL | 50 MG | COMP PEL | B/4 | Upjohn EESV | C | T | 26/03/2021 |
46 | VIAGRA | SILDENAFIL | 25MG | COMP PEL | B/4 | Upjohn EESV | C | T | 26/03/2021 |