Dossiers d'AMM à étudier par le Comité Technique des Spécialités Pharmaceutiques du 30/01/2019.
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 la demande | DATE BA |
1 | GUERRIVIT | TRIMEBUTINE | 200 mg | cp pelliculé | B/18 | MEDIS | I | N | 04/01/2019 |
2 | ROSUVAST | Atorvastatine | 40 mg | cp pell | Fl/30 | TAHAPHARMA | E | N | 08/01/2019 |
3 | MEDZAR | Losartan | 50 mg | cp pell sécable | B/90 | DAR ESSAYDALI |
E | N | 20/01/2019 |
4 | MEDZAR FORT | Losartan | 100 mg | Cp pél séc | B/90 | DAR ESSAYDALI |
E | N | 20/01/2019 |
5 | CO-MEDZAR | Losartan + Hydrochlorthiazide | 50/12.5mg | cp pell sécable | B/90 | DAR ESSAYDALI |
E | N | 20/01/2019 |
6 | CO-MEDZAR FORT | Losartan + Hydrochlorthiazide | 100/25 mg | cp pell sécable | B/90 | DAR ESSAYDALI |
E | N | 20/01/2019 |
7 | TIAFEN | ACIDE TIAPROFENIQUE | 100 MG | Comprimé | B/30 | SIMED | E | N | 22/01/2019 |
8 | TIAFEN | ACIDE TIAPROFENIQUE | 200 MG | Comprimé sécable | B/20 | SIMED | E | N | 23/01/2019 |
* Produits à évaluer pour la première fois au Comité Technique
N° | Médicament | DCI | Dosage | Forme Pharmaceutique | Présentation | Titulaire | VEIC | Type de la demande | Date BA |
1 | ITRAZOL | Itraconazole | 100 mg | Cp | B/4 | ADWYA | E | V | 26/11/2018 |
2 | ITRAZOL | Itraconazole | 100 mg | Cp | B/16 | ADWYA | E | V | 26/11/2018 |
3 | ITRAZOL | Itraconazole | 100 mg | Cp | B/32 | ADWYA | E | V | 26/11/2018 |
4 | ZENDIS | albendazole | 4% | Susp buv | F/10 ml | SIMED | E | V | 26/11/2018 |
5 | RULID 150 | Roxithromycine | 150mg | cp | B/12 | SANOFI | E | V | 26/11/2018 |
6 | DIAREN ENFANT | Racecadotril | 30 mg | poudre pour solution orale | B/30 | PHARMAGHREB | I | N | 10/12/2018 |
7 | DYSFEN | Flurbiprofène | 100 mg | cp pelliculé | B/20 | SAIPH | E | N | 10/12/2018 |
8 | MEMIXA | Mémantine | 10mg | cp pelliculé | B/40 | TERIAK | E | N | 13/12/2018 |
9 | MEMIXA | Mémantine | 10mg | cp pelliculé | B/60 | TERIAK | E | N | 13/12/2018 |
10 | MEMIXA | Mémantine | 20mg | cp pelliculé | B/30 | TERIAK | E | N | 13/12/2018 |
11 | DOLVEN | Ibuprfène | 400 mg | Cp pelliculés | B/20 | TERIAK | E | V | 13/12/2018 |
12 | DOLVEN | Ibuprfène | 600 mg | Cp pelliculés | B/20 | TERIAK | E | N | 13/12/2018 |
13 | DOLVEN RHUME | Ibuprofene+ pseudoéphédrine | 200 mg /30 mg | Cp pelliculés | B/20 | TERIAK | E | N | 13/12/2018 |
14 | DOLVEN RHUME | Ibuprofene+pseudoéphédrine | 400 mg /60 mg | Cp pelliculés | B/20 | TERIAK | E | N | 13/12/2018 |
15 | TELMICARDIS DUO | Telmisartan+ Amlodipine |
80 mg/10 mg | Cp | B/30 | THERA | E | N | 13/12/2018 |
16 | TADAPLUS | Tadalafil | 5 mg | Cp | B/30 | SAIPH | C | N | 13/12/2018 |
17 | TADAPLUS | Tadalafil | 10 mg | Cp | B/4 | SAIPH | C | N | 13/12/2018 |
18 | TADAPLUS | Tadalafil | 10 mg | Cp | B/8 | SAIPH | C | N | 13/12/2018 |
19 | TADAPLUS | Tadalafil | 20 mg | Cp | B/4 | SAIPH | C | N | 13/12/2018 |
20 | TADAPLUS | Tadalafil | 20 mg | Cp | B/8 | SAIPH | C | N | 13/12/2018 |
21 | ATROVAST10 | Atorvastatine | 10mg | Cp | B/30 | PHARMACARE | E | N | 19/12/2018 |
22 | ATROVAST20 | Atorvastatine | 20mg | Cp | B/30 | PHARMACARE | E | N | 19/12/2018 |
23 | ATROVAST40 | Atorvastatine | 40mg | Cp | B/30 | PHARMACARE | E | N | 19/12/2018 |
24 | ATROVAST80 | Atorvastatine | 80mg | Cp | B/30 | PHARMACARE | E | N | 19/12/2018 |
25 | SPASMOSTOP | Phloroglucinol | 80 mg | cp oro-dispersible | B/10 | ADVANS | I | N | 07/01/2019 |
26 | SPASMOSTOP | Phloroglucinol | 160 mg | cp oro-dispersible | B/10 | ADVANS | I | N | 07/01/2019 |
27 | RANYDYS | Ranitidine | 50 mg/2ml | Sol Inj | B/5 | MEDIS | E | N | 08/01/2019 |
28 | RANYDYS | Ranitidine | 50 mg/2ml | Sol Inj | B/50 | MEDIS | E | N | 08/01/2019 |
29 | TELMICARDIS PLUS | Telmicardis +hydrochlorothiazide | 40 mg/12.5mg | cp | B/30 | THERA | E | N | 08/01/2019 |
30 | TELMICARDIS PLUS | Telmicardis +hydrochlorothiazide | 80 mg/12.5mg | cp | B/30 | THERA | E | N | 08/01/2019 |
31 | TELMICARDIS PLUS | Telmicardis +hydrochlorothiazide | 80 mg/25mg | cp | B/30 | THERA | E | N | 08/01/2019 |
32 | AZACITIDINE NEAPOLIS | Azacitidine | 100 mg | poudre pour solution injectable | B/01 | NEAPOLIS | V | N | 08/01/2019 |
33 | PARAMED | Paracetamol | 10mg/ml | solution injectable | B/6 | UNIMED | E | N | 16/01/2019 |
34 | PEMETREXED NEAPOLIS | Pemetrexed | 100 mg | poudre pour solution injectable | B/01 | NEAPOLIS | V | N | 22/01/2019 |
35 | CISATREX FORT | Cisatracurium | 5mg/ml | solution injectable | B/1 | MEDIS | V | N | 22/01/2019 |
36 | MONOREL | Glimépiride | 6mg | Comprimé sécable | B/30 | DAR ESSAYDALI | E | N | 25/01/2019 |
37 | MONOREL | Glimépiride | 6mg | Comprimé sécable | B/90 | DAR ESSAYDALI | E | N | 25/01/2019 |
38 | OLANZIA ORO | Olanzapine | 10mg | comprimé orodispersible | B/10 | ADVANS | E | N | 25/01/2019 |
39 | OLANZIA ORO | Olanzapine | 10mg | comprimé orodispersible | B/30 | ADVANS | E | N | 25/01/2019 |
40 | OLANZIA ORO | Olanzapine | 20mg | comprimé orodispersible | B/10 | ADVANS | E | N | 25/01/2019 |
41 | OXYBTAN | Oxybutinine | 5mg | Comprimé sécable | B/60 | ADVANS | I | N | 25/01/2019 |
42 | PEMETREXED NEAPOLIS | Pemetrexed | 500 mg | poudre pour solution injectable | B/01 | NEAPOLIS | V | N | 25/01/2019 |