Dossiers d'AMM à étudier par le Comité Technique des Spécialités Pharmaceutiques du 29/07/2020.
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 | HYPOTEN 50 | ATENOLOL | 50 mg | Comprimé pelliculé sécable | B/100 | IBN AL BAYTAR | E | N | - - |
2 | CAPRIL | CAPTOPRIL | 50 mg | Comprimé sécable | B/150 | IBN AL BAYTAR | E | N | - - |
3 | LOWRADIP | LERCANIDIPINE | 10 mg | Comprimé pelliculé sécable | B/30 | SAIPH | E | N | 02/07/2020 |
4 | LOWRADIP | LERCANIDIPINE | 20 mg | Comprimé pelliculé sécable | B/30 | SAIPH | E | N | 02/07/2020 |
5 | ORTOTON | METHOCARBAMOL | 750 mg | Comprimé pelliculé | B/20 | OPALIA PHARMA | N | 02/07/2020 | |
6 | ORTOTON | METHOCARBAMOL | 750 mg | Comprimé pelliculé | B/50 | OPALIA PHARMA | N | 02/07/2020 | |
7 | GALVINE | VILDAGLIPTINE | 50 mg | Comprimé | B/30 | SAIPH | E | N | 02/07/2020 |
8 | XYTEC | LEVOCETIRIZINE | 5 mg | Comprimé pelliculé | B/7 | SIMED | E | N | 02/07/2020 |
9 | XYTEC | LEVOCETIRIZINE | 5 mg | Comprimé pelliculé | B/14 | SIMED | E | N | 02/07/2020 |
10 | XYTEC | LEVOCETIRIZINE | 5 mg | Comprimé pelliculé | B/28 | SIMED | E | N | 02/07/2020 |
11 | TRIMAX UNO | AZITHROMYCINE | 500 mg | Comprimé pelliculé sécable | B/2 | TAHA PHAMA | E | N | 01/07/2020 |
12 | ACTICIL | AMBROXOL | 0.6% | Solution buvable | FL/150 ml | GALPHARMA | I | N | 08/07/2020 |
13 | B12 INJECT | VITAMINE B12 | 1000 µg /ML | Solution injectable | B/4 Ampoules de 1 ML | STERIPHARM | E | N | 19/06/2020 |
14 | B12 INJECT | VITAMINE B12 | 1000 µg /ML | Solution injectable | B/50 Ampoules de 1 ML | STERIPHARM | E | N | 19/06/2020 |
15 | ROZUVIE 10 | ROSUVASTATINE | 10 mg | Comprimé pelliculé | B/90 | SAIPH | E | N | - - |
16 | ROZUVIE 20 | ROSUVASTATINE | 20 mg | Comprimé pelliculé | B/90 | SAIPH | E | N | - - |
17 | IMATINIB NEAPOLIS | IMATINIB | 100 mg | Comprimé pelliculé | B/30 | NEAPOLIS PHARMA | V | N | 20/07/2020 |
18 | IMATINIB NEAPOLIS | IMATINIB | 100 mg | Comprimé pelliculé | B/30 | NEAPOLIS PHARMA | V | N | 20/07/2020 |
19 | IMATINIB NEAPOLIS | IMATINIB | 400 mg | Comprimé pelliculé | B/30 | NEAPOLIS PHARMA | V | N | 20/07/2020 |
20 | LOXEN LP | NICARDIPINE | 50 mg | Gélule à libération prolongé | B/60 | TERIAK | E | N | 20/07/2020 |
21 | NEBICOR | NEBIVOLOL | 5 mg | Comprimé sécable | B/30 | ADVANS PHARMA | E | N | 20/07/2020 |
22 | NEMACEST | Albendazole | 4% | suspension buvable | Fl/10 ml | GALPHARMA | E | N | 21/07/2020 |
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 | BUTRANS | BUPRENORPHINE | 5ug/h | Dispositif transdermique | B/4 Patchs | Napp Pharmaceuticals Limited | V | N | 07/04/2020 |
2 | BUTRANS | BUPRENORPHINE | 10ug/h | Dispositif transdermique | B/4 Patchs | Napp Pharmaceuticals Limited | V | N | 07/04/2020 |
3 | BUTRANS | BUPRENORPHINE | 20ug/h | Dispositif transdermique | B/4 Patchs | Napp Pharmaceuticals Limited | V | N | 07/04/2020 |
4 | OXYNORM | OXYCODONE | 10mg/ml | SOL INJ | B/5/1ml | Napp Pharmaceuticals Limited | V | N | 07/04/2020 |
5 | OXYNORM | OXYCODONE | 20mg/ml | SOL INJ | B/5/2ml | Napp Pharmaceuticals Limited | V | N | 07/04/2020 |
6 | OXYCONTIN | OXYCODONE | 10mg | CP à liberation prolongée | B/20 | PURDUE PHARMA | E | N | 07/04/2020 |
7 | OXYCONTIN | OXYCODONE | 15mg | CP à liberation prolongée | B/20 | PURDUE PHARMA | E | N | 07/04/2020 |
8 | OXYCONTIN | OXYCODONE | 20mg | CP à liberation prolongée | B/20 | PURDUE PHARMA | E | N | 07/04/2020 |
9 | OXYCONTIN | OXYCODONE | 30mg | CP à liberation prolongée | B/20 | PURDUE PHARMA | E | N | 07/04/2020 |
10 | OXYCONTIN | OXYCODONE | 40mg | CP à liberation prolongée | B/20 | PURDUE PHARMA | E | N | 07/04/2020 |
11 | RAPAMUNE | SIROLIMUS | 1mg | cp enrobé | B/30 | PFIZER Europe MA EEIG | E | N | 13/04/2020 |
12 | CANCIDAS | CASPOFUNGINE | 50mg | Poudre pour prep injectable | B/1 | MSD | E | N | 17/04/2020 |
13 | CANCIDAS | CASPOFUNGINE | 70mg | Poudre pour prep injectable | B/1 | MSD | E | N | 17/04/2020 |
14 | ZYTIGA | ABIRATERONE | 250 mg | CP PEL | B/120 | Janssen-Cilag International N.V | V | V | 12/05/2020 |
15 | HERCEPTIN SOUS-CUTANE | TRASTUZUMAB | 600mg | SOL INJ | FL/5ml | ROCHE PHARMA (SCHWEIZ) LTD SUISSE | V | N | 19/05/2020 |
16 | ACIDE ZOLEDRONIQUE MYLAN | ACIDE ZOLÉDRONIQUE | 4 MG/5 ML | SOL INJ | B/ 1FL/ 5ml | MYLAN S.A.S | E | N | 22/05/2020 |
17 | ZELBORAF | VEMURAFENIB | 240 mg | CP PEL | B/56 | ROCHE PHARMA (SCHWEIZ) LTD SUISSE | V | N | 28/05/2020 |
18 | FASLODEX | FLUVESTRANT | 250 mg | SOL INJ | B/2/5ML | ASTRA ZENECA | V | V | 02/06/2020 |
19 | TOUJEO | INSULINE GLARGINE | 300unités/ml | SOL INJ | B/3 Stylos | SANOFI-AVENTIS Deutschland GmbH | V | N | 02/06/2020 |
20 | CYCLOGEST | PROGESTERONE | 200 MG | OVULE | B/15 | L.D.Collins & Co.ltd | E | N | 05/06/2020 |
21 | SUXAMETHONIUM CHLORID VUAB | SUXAMETHONIUM | 100 mg | PDRE PR SUS INJ | B/1FL | VUAB PHARMA AS | V | N | 26/06/2020 |
22 | AERIUS | DESLORATADINE | 0.5 mg/ml | SOL BUV | FL/150 ml | MERCK SHARP & DOHME BV | E | N | 25/06/2020 |
23 | CLARISCAN | MEGLUMINE GODATERATE | 0.5mmol/ml | SOL INJ | B/10FL/10 ML | GE HEALTHCARE AS NORVEGE | E | N | 30/06/2020 |
24 | CLARISCAN | MEGLUMINE GODATERATE | 0.5mmol/ml | SOL INJ | B/10FL/15 ML | GE HEALTHCARE AS NORVEGE | E | N | 30/06/2020 |
25 | CLARISCAN | MEGLUMINE GODATERATE | 0.5mmol/ml | SOL INJ | B/10FL/20ML | GE HEALTHCARE AS NORVEGE | E | N | 30/06/2020 |
26 | DARZALEX | DARATUMUMAB | 20mg/ml | SOL INJ | B/1FL/20ML | Janssen-Cilag International N.V | N | 02/07/2020 | |
27 | DARZALEX | DARATUMUMAB | 20mg/ml | SOL INJ | B/1FL/5ML | Janssen-Cilag International N.V | N | 02/07/2020 | |
28 | PURINETHOL | MERCAPTOPURINE | 50 MG | CP SEC | FL/25 | ASPEN PHARMA | V | V |
* 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 | CYCLOGEST | PROGESTERONE | 400 mg | OVULE | B/15 | L.D.Collins & Co.ltd | E | N | TRANSFERT 22/07/2019 |
2 | SUXAMETHONIUM-LABESFAL | SUXAMETHONIUM | 100 MG/2ML | SOL INJ | B/100/2ML | LABESFAL | V | V | CS 06/01/2020 |
3 | DESLORATADINE GENEPHARM | DESLORATADINE | 5 MG | COMP | B/30 | GENEPHARM S.A | E | N | 15/01/2020 |
4 | DESLORATADINE GENEPHARM | DESLORATADINE | 2,5 MG | COMP | B/30 | GENEPHARM S.A | E | N | 15/01/2020 |
5 | LEVONORGESTREL MYLAN | LEVONORGESTREL | 1.5 mg | COMP | B/1 | MYLAN S.A.S | E | N | 15/01/2020 |
6 | VAXIGRIP | VACCIN ANTIGRIPPE | SUSP INJ | B/1SER/0,5 ML | SANOFI PASTEUR SA | I | V | CS 17/01/2020 | |
7 | MORPHINE CHLORHYDRATE | MORPHINE | 10 mg/ml (0.1%) | SOL INJ | B/10/1 ML | RENAUDIN | V | N | RE 23/01/2020 |
8 | JADENU | DEFERASIROX | 360MG | COMP PEL | B/30 | NOVARTIS PHARMA SCHWEIZ AG | V | N | 22/01/2020 |
9 | JADENU | DEFERASIROX | 180MG | COMP PEL | B/90 | NOVARTIS PHARMA | V | N | 22/01/2020 |
10 | JADENU | DEFERASIROX | 90MG | COMP PEL | B/90 | NOVARTIS PHARMA | V | N | 22/01/2020 |
11 | VESOMNI | SOLIFENACINE+ TAMSULOSINE | 6mg/0.4mg | COMP | B/30 | ASTELLAS PHARMA EUROPE B.V HOLLANDE | N | 22/01/2020 | |
12 | TOMEC | DORZOLAMIDE+ TIMOLOL | 100 mg/ 25mg | COLLYRE | FL/5 ml | ABDI IBRAHIM IIac San. ve Tic. A.S. | E | N | 22/01/2020 |
13 | OFNOL | OLOPATADINE | 0.1% | COLLYRE | FL/5 ml | ABDI IBRAHIM IIac San. ve Tic. A.S. | E | N | 04/02/2020 |
14 | ORAP | PIMOZIDE | 4 MG | COMP | B/30 | EUMEDICA PHARMACEUTICALS GmbH | E | N | TRANSFERT 04/02/2020 |
15 | LYRICA | PREGABALINE | 75 mg | GEL | B/56 | PFIZER Europe MA EEIG | V | N | TRANSFERT 04/02/2020 |
16 | LYRICA | PREGABALINE | 75 mg | GEL | B/56 | PFIZER Europe MA EEIG | V | N | TRANSFERT 04/02/2020 |
17 | LYRICA | PREGABALINE | 150 mg | GEL | B/14 | PFIZER Europe MA EEIG | V | N | TRANSFERT 04/02/2020 |
18 | ALECENSA | ALECTINIB | 150 MG | GELULE | B/224 | ROCHE PHARMA (SCHWEIZ) LTD SUISSE | N | 10/02/2020 | |
19 | NOCDURNA | DESMOPRESSINE | 50 µg | LYOPHI ORAL | B/30 | FERRING ARZNEIMITTEL GmbH | E | N | 17/02/2020 |
20 | NOCDURNA | DESMOPRESSINE | 25 µg | LYOPHI ORAL | B/30 | FERRING ARZNEIMITTEL GmbH | E | N | 17/02/2020 |
21 | TOBREX | TOBRAMYCINE | 0.3% | pommade ophtalmo | Tube/3.5 gr | NOVARTIS PHARMA SCHWEIZ AG | E | N | 17/02/2020 |
22 | TOBRADEX | DEXAMETHASONE+ TOBRAMYCINE | 100 mg/300 mg | COLLYRE | FL/5 ml | NOVARTIS PHARMA SCHWEIZ AG | E | N | 17/02/2020 |
23 | DIPIPERON | PIPAMPERONE | 40 MG | COMP | B/20 | EUMEDICA PHARMACEUTICALS GmbH | E | N | Transfert 19/02/2020 |
24 | COSENTYX | SECUKINUMAB | 150MG/ML | SOL INJ | B/2 seringues pré_remplis | NOVARTIS EUROPHARM LIMITED IRLANDE | E | N | Transfert 21/02/2020 |
25 | COSENTYX | SECUKINUMAB | 150MG/ML | SOL INJ | B/2 Stylos pré_remplis | NOVARTIS EUROPHARM LIMITED IRLANDE | E | N | Transfert 21/02/2020 |
26 | ENBREL | ETANERCEPT | 50 mg | SOL INJ | B/4 stylos pré-remplis | PFIZER Europe MA EEIG | E | N | Transfert 21/02/2020 |
27 | ENBREL | ETANERCEPT | 25 mg | SOL INJ | B/4 seringues pré-remplis | PFIZER Europe MA EEIG | E | N | Transfert 21/02/2020 |
28 | CETROTIDE | CETRORELIX | 0.25 MG | PDRE PR PREP INJ | B/1FL+SER/1ML | MERCK EUROPE B.V | E | N | Transfert 21/02/2020 |
29 | PERJETA | PERTUZUMAB | 450 MG | SOL INJ | B/1 | ROCHE PHARMA (SCHWEIZ) LTD SUISSE | E | V | CS 12/03/2020 |
30 | STOCRIN | EFAVIRENZ | 30mg/ml | SOL BUVABLE | B/ 01 flacon de 180 ml | MSD PAYS BAS | V | N | 16/04/2020 |
31 | PROGESTAN | PROGESTERONE | 100 MG | CAPSULE MOLLE | B/30 | BESINS INTERNATIONAL | E | N | RE 08/05/2020 |
32 | PROGESTAN | PROGESTERONE | 200 MG | CAPSULE MOLLE | B/15 | BESINS INTERNATIONAL | E | N | RE 08/05/2020 |
33 | FORXIGA | DAPAGLIFLOZINE | 5 MG | COMPRIME | B/28 | ASTRA ZENECA | E | N | RE du 08/05/2020 |
34 | FORXIGA | DAPAGLIFLOZINE | 10 MG | COMPRIME | B/28 | ASTRA ZENECA | E | N | RE du 08/05/2020 |
35 | JANUVIA | SITAGLIPTINE | 100 MG | COMPPRIME | B/28 | MSD PAYS BAS | E | N | TRANSFERT DU 08/05/2020 |
36 | REDEX | TADALAFIL | 5 MG | COMPRIME | B/28 | ATTAQADDOM JORDANIE | C | N | RE 12/05/2020 |
37 | REDEX | TADALAFIL | 10MG | COMPRIME | B/2 | ATTAQADDOM JORDANIE | C | N | RE 12/05/2020 |
38 | REDEX | TADALAFIL | 75MG | COMPRIME | B/2 | ATTAQADDOM JORDANIE | C | N | RE 12/05/2020 |
39 | MERIONAL HG | GONODOTROPHINE MENOPAUSIQUE HUMAINE | 150 UI/ML | POUDRE P PREPARATION INJECTABLE | B/1FL+AP DE SOLVANT | IBSA BIOCHIMIQUE SA SUISSE | E | N | RE du 26/05/2020 |
40 | MERIONAL HG | GONODOTROPHINE MENOPAUSIQUE HUMAINE | 75 UI/ML | POUDRE P PREPARATION INJECTABLE | B/1FL+AP DE SOLVANT | IBSA BIOCHIMIQUE SA SUISSE | E | N | RE du 26/05/2020 |
41 | HYPNOMIDATE | ETOMIDATE | 2 mg/ml | SOL INJ | B/5/10 ml | Piramal Critical Care B.V. | V | N | TRANSFERT 20/05/2020 |
42 | TYGACIL | TIGECYCLINE | 50 MG | PDRE P PREP INJ | B/10 flacons | PFIZER Europe MA EEIG | E | N | TRANSFERT 22/05/2020 |
43 | LUVERIS | LUTROPIN ALFA | 75 UI | PDRE PR PREP INJ | B/1 FL | MERCK EUROPE B.V | E | N | TRANSFERT 05/06/2020 |
44 | ANDROCUR | CYPROTERONE | 50 MG | COMP SEC | B/20 | JENAPHARM GmbH& Co.KG | V | N | TRANSFERT 11/06/2020 |
45 | LAXALATE | ESCITALOPRAM | 10 mg | COMP PEL SEC | B/28 | JENAPHARM GmbH& Co.KG | E | N | RE du 19/06/2020 |
46 | LAXALATE | ESCITALOPRAM | 20 mg | COMP PEL SEC | B/28 | JENAPHARM GmbH& Co.KG | E | N | RE du 19/06/2020 |
47 | FOSTER | BECLOMETHASONE+FORMOTEROL | 200 / 6µg/dose | SOL PR INH | Fl /120 doses | CHIESI FARMACEUTICI S.p.A | E | N | RE du 19/06/2020 |
48 | COLLYRE BLEU LAITER | METHYLTHIONINIUM+NAPHAZOLINE NITRATE | 0.020 g/0.050 g | COLLYRE | FL/10 ml | Laboratoires NEITUM | I | N | TRANSFERT 24/06/2020 |
49 | VIAGRA | SILDENAFIL | 50 MG | COMP | B/4 | PFIZER Europe MA EEIG | C | N | TRANSFERT 26/06/2020 |
50 | VIAGRA | SILDENAFIL | 50 MG | COMP | B/2 | PFIZER Europe MA EEIG | C | N | TRANSFERT 26/06/2020 |
51 | VIAGRA | SILDENAFIL | 50 MG | COMP | B/8 | PFIZER Europe MA EEIG | C | N | TRANSFERT 26/06/2020 |
52 | TECENTRIQ | ATEZOLIZUMAB | 1200mg | SOL INJ | B/1FL/20ML | ROCHE PHARMA (SCHWEIZ) LTD SUISSE | N | RE du 23/07/2020 |