Dossiers d'AMM à étudier par le Comité Technique des Spécialités Pharmaceutiques du 15/05/2019.
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 BA |
1 | CARBODIAL | Acarbose | 50 mg | cp | B/90 | NEAPOLIS | E | N | 28/02/2019 |
2 | CARBODIAL | Acarbose | 100 mg | cp | B/90 | NEAPOLIS | E | N | 28/02/2019 |
3 | SPASCARE | Phloroglucinol | 80 mg | cp oro-dispersible | B/20 | PHARMACARE | I | N | 04/03/2019 |
4 | SPASCARE | Phloroglucinol | 160 mg | cp oro-dispersible | B/10 | PHARMACARE | I | N | 04/03/2019 |
5 | AZEAL FREE | AZELASTINE | 0.05% | collyre | Fl multidose /6 ml | UNIMED | E | N | 04/03/2019 |
6 | PAREXAT | PAROXETINE | 20mg | cp pelliculé sécable | B/60 | PHARMAGHEB | E | N | 07/03/2019 |
7 | FYLCOL | FLUCONAZOLE | 150 mg | Gélule | B/12 | TAHA PHARMA | E | N | 07/03/2019 |
8 | EBUVIR 400 | SOFOSBUVIR | 400 mg | Comprimé pelliculé | FL/10 | NEWIX | E | N | 12/03/2019 |
9 | DIARIX | RIFAXIMINE | 200 mg | Comprimé pelliculé | B/42 | GALPHARMA | I | N | 12/03/2019 |
10 | UROSINE 10 | ALFUZOSINE | 10 mg | Comprimé pelliculé lp | B/90 | TAHA PHARMA | I | N | 15/03/2019 |
11 | ANTISPASM | Phloroglucinol | 80 mg | Comprimé orodispersible | B/30 | TAHA PHARMA | I | N | 15/03/2019 |
12 | ADONTAG | PREGABALINE | 75 mg | Gélule | FL/14 | TAHA PHARMA | V | N | 15/03/2019 |
13 | CIPROFLEX | CIPROFLOXACINE | 750mg | cp pelliculé | B/15 | TAHA PHARMA | E | N | 01/04/2019 |
14 | SPIRACTONE | Spironolactone | 25mg |
cp sécable | B/30 | PHARMACARE | E | N | 01/04/2019 |
15 | SPIRACTONE | Spironolactone | 75 mg |
cp sécable | B/30 | PHARMACARE | E | N | 01/04/2019 |
16 | SPIRACTONE | Spironolactone | 100 mg | cp sécable | B/30 | PHARMACARE | E | N | 01/04/2019 |
17 | ROSACT | ROSUVASTATINE | 10mg |
cp pell | B/30 | ACTPHARMA | E | N | 01/04/2019 |
18 | ROSACT | ROSUVASTATINE | 20mg | cp pell | B/30 | ACTPHARMA | E | N | 01/04/2019 |
19 | DIFEN EMULGEL |
DICLOFENAC | 10 mg | Gel dermique | T/50g | PHARMADERM | C | N | 01/04/2019 |
20 | CYVAX | SALMETEROL + FLUCONAZOLE | 50µg/25µg/dose | Suspension pour inhalation | Fl/120 doses | BERG LIFE SCIENCES | E | N | 01/04/2019 |
21 | LEVOJECT | LEVOFLOXACINE | 5mg/ml | Sol inj pr perfusion | Poche/100ml | UNIMED | E | N | 03/04/2019 |
22 | LEVOJECT | LEVOFLOXACINE | 5mg/ml | Sol inj pr perfusion | B/10P/100ml | UNIMED | E | N | 03/04/2019 |
23 | TENSIOVALS 80 | VALSARTAN | 80mg | Cp pel sec | B/90 | TAHAPHARMA | E | N | 03/04/2019 |
24 | TENSIOVALS 160 | VALSARTAN | 80mg | Cp pel sec | B/90 | TAHAPHARMA | E | N | 03/04/2019 |
25 | TENSIOVALS DUO | VALSARTAN AMLODIPINE | 80mg /5mg | Cp pel sec | B/90 | TAHAPHARMA | E | N | 03/04/2019 |
26 | TENSIOVALS DUO | VALSARTAN AMLODIPINE | 160mg /5mg | Cp pel sec | B/90 | TAHAPHARMA | E | N | 03/04/2019 |
27 | TENSIOVALS DUO | VALSARTAN AMLODIPINE | 160mg /10mg | Cp pel sec | B/90 | TAHAPHARMA | E | N | 03/04/2019 |
28 | ROSUVAST | ROSUVASTATINE | 10mg | cp pell | B/90 | TAHAPHARMA | E | N | 08/04/2019 |
29 | ROSUVAST | ROSUVASTATINE | 20mg | cp pell | B/90 | TAHAPHARMA | E | N | 08/04/2019 |
30 | PRERICA | PREGABALINE | 75 mg | Gélule | B/28 | PHARMACARE | V | N | 16/04/2019 |
31 | IBUPHIL COLD | IBUPROFENE + PSEUDOEPHEDRINE CHLORHYDRATE | 200 mg /30 mg | cp pell | B/15 | PHILADELPHIA | C | V | 18/04/2019 |
32 | IBUPHIL COLD | IBUPROFENE + PSEUDOEPHEDRINE CHLORHYDRATE | 400 mg /30 mg | cp pell | B/15 | PHILADELPHIA | C | V | 19/04/2019 |
33 | SITAGLIP | SITAGLIPTINE | 100mg | cp pell | B/30 | THERA | E | N | 26/04/2019 |
34 | LODIPEX 5 | AMLODIPINE | 5mg | comprimé | B/90 | TAHA PHARMA | E | N | 26/04/2019 |
35 | CORTIDEX | MOMETASONE | 0,10% | crème dermique | T/30g | PHARMADAERM | E | N | 03/05/2019 |
36 | CORTIDEX | MOMETASONE | 0,10% | Pde dermique | T/30g | PHARMADAERM | E | N | 03/05/2019 |
37 | TAHOR | Atorvastatine | 10mg | cp pell | B/28 | Pfizer Tunisie | E | V | 03/05/2019 |
38 | TAHOR | Atorvastatine | 10mg | cp pell | B/56 | Pfizer Tunisie | E | V | 03/05/2019 |
39 | TAHOR | Atorvastatine | 10mg | cp pell | B/91 | Pfizer Tunisie | E | V | 03/05/2019 |
40 | TAHOR | Atorvastatine | 20mg | cp pell | B/28 | Pfizer Tunisie | E | V | 03/05/2019 |
41 | TAHOR | Atorvastatine | 20mg | cp pell | B/91 | Pfizer Tunisie | E | V | 03/05/2019 |
42 | TAHOR | Atorvastatine | 40 mg | cp pell | B/28 | Pfizer Tunisie | E | V | 03/05/2019 |
43 | TAHOR | Atorvastatine | 40 mg | cp pell | B/91 | Pfizer Tunisie | E | V | 03/05/2019 |
44 | SECTRAL | Acebutolol | 200mg | cp pell | B/20 | Winthrop pharma | E | V | 03/05/2019 |
45 | AMLOR | Amlodipine | 5mg | cp pell | B/30 | Pfizer Tunisie | E | V | 03/05/2019 |
46 | AMLOR | Amlodipine | 5mg | cp pell | B/60 | Pfizer Tunisie | E | V | 03/05/2019 |
47 | AMLOR | Amlodipine | 5mg | cp pell | B/90 | Pfizer Tunisie | E | V | 03/05/2019 |
48 | CARDEPINE | Amlodipine | 5mg | cp pell | B/32 | Alliance Pharma | E | V | 03/05/2019 |
49 | AMLODIPINE ZENTIVA | Amlodipine | 5mg | cp pell | B/30 | Winthrop pharma | E | V | 03/05/2019 |
50 | TENSYNEL | Amlodipine | 5mg | cp pell | B/30 | Ibn al Baytar | E | V | 03/05/2019 |
51 | TENSYNEL | Amlodipine | 5mg | cp pell | B/90 | Ibn al Baytar | E | V | 03/05/2019 |
52 | BUPICAINE | Bupivacaine | 0.25% | sol inj | B/10/10ml | Unimed | E | V | 03/05/2019 |
53 | BUPICAINE | Bupivacaine | 0.25% | sol inj | B/10/20ml | Unimed | E | V | 03/05/2019 |
54 | BUPICAINE | Bupivacaine | 0.5% | sol inj | B/10/10ml | Unimed | E | V | 03/05/2019 |
55 | BUPICAINE | Bupivacaine | 0.5% | sol inj | B/10/20ml | Unimed | E | V | 03/05/2019 |
56 | CO-ZARTAN | Losartan + HTZ | 50mg/12.5mg | cp pell | B/30 | Adwya | E | V | 03/05/2019 |
57 | CO-ZARTAN | Losartan + HTZ | 50mg/12.5mg | cp pell | B/90 | Adwya | E | V | 03/05/2019 |
58 | CO-ZARTAN FORT | Losartan + HTZ | 100mg /25 mg | cp pell | B/30 | Adwya | E | V | 03/05/2019 |
59 | CO-ZARTAN FORT | Losartan + HTZ | 100mg /25 mg | cp pell | B/90 | Adwya | E | V | 03/05/2019 |
60 | DRICOD | Butamirate citrate | 0.15% | sirop | Fl/100ml | Simed | C | V | 03/05/2019 |
61 | DRICOD | Butamirate citrate | 0.15% | sirop | Fl/200ml | Simed | C | V | 03/05/2019 |
62 | CIPTADINE | Cyproheptadine | 4mg | cp sec | B/30 | Ibn Al Baytar | E | V | 03/05/2019 |
63 | BRONCHOCINE | Chlorydrate de tetracycline + Chlorydrate de Bromexine | 250mg/4mg | cp pell | B/20 | Siphat | E | V | 03/05/2019 |
64 | APPELOM | Mémantine | 10 mg | cp pelliculé | B/30 | Act Pharma | E | N | 07/05/2019 |
65 | APPELOM | Mémantine | 20 mg | cp pelliculé | B/30 | Act Pharma | E | N | 07/05/2019 |
66 | PERINASE | Fluticasone | 50µg/dose | suspension nasale | Fl/120 doses | Adwya | E | N | 07/05/2019 |
67 | LOWRAC PLUS | AMLODIPINE VALSARTAN | 5mg /80mg | cp pelliculé | B/30 | SAIPH | E | N | 07/05/2019 |
68 | LOWRAC PLUS | AMLODIPINE VALSARTAN | 5mg /160mg | cp pelliculé | B/30 | SAIPH | E | N | 07/05/2019 |
69 | LOWRAC PLUS | AMLODIPINE VALSARTAN | 10mg /160mg | cp pelliculé | B/30 | SAIPH | E | N | 07/05/2019 |
70 | GLIPTAMET | VILDAGLIPTINE + METFORMINE | 50 mg /850 mg | cp pelliculé | B/60 | GALPHARMA | E | N | 10/05/2019 |
71 | RHUMAGRIP | Paracetamol+ Pseudoéphedrine | 500mg+30mg | Cp sec | B/20 | GALIEN PHARMACEUTICAL | C | N |