Dossiers d'AMM à étudier par le Comité Technique des Spécialités Pharmaceutiques du 17/04/2019.
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 demande | Date BA |
1 | ARALEAD | Candésartan cilextil |
16 mg | cp pell sécable | B/30 | NEAPOLIS | E | N | 11/02/2019 |
2 | ARALEAD | Candésartan cilextil |
16 mg | cp pell sécable | B/90 | NEAPOLIS | E | N | 11/02/2019 |
3 | ARALEAD | Candésartan cilextil |
32 mg | cp pell sécable | B/30 | NEAPOLIS | E | N | 11/02/2019 |
4 | ARALEAD | Candésartan cilextil |
32 mg | cp pell sécable | B/90 | NEAPOLIS | E | N | 11/02/2019 |
5 | FUSIBACTER 250 | Fusidate de sodium | 250 mg | cp pell | B/12 | TAHA PHARMA | E | N | 11/02/2019 |
6 | FUSIBACTER 250 | Fusidate de sodium | 250 mg | cp pell | B/18 | TAHA PHARMA | E | N | 12/02/2019 |
7 | OLANZIA ORO | Olanzapine | 10mg | cp orodispersible | B/30 | ADVANS PHARMA | E | N | 28/02/2019 |
8 | OLANZIA ORO | Olanzapine | 10mg | cp orodispersible | B/10 | ADVANS PHARMA | E | N | 28/02/2019 |
9 | OLANZIA ORO | Olanzapine | 20mg | cp orodispersible | B/30 | ADVANS PHARMA | E | N | 28/02/2019 |
10 | ODYCIN | Moxifloxacine | 0.5% | Collyre | Fl/3ml | ADWYA | E | N | 11/03/2019 |
11 | ASMATHYL | Montelukast | 5mg | Cp à croquer | B/30 | GALPHARMA | E | N | 12/03/2019 |
12 | DOLIRHUME EXTRA | Paracétamol Phényléphedrine Caféine |
500mg/5mg/25mg | pelliculé sécable | B/16 | Winthrop Pharma Tunisie | E | N | 19/03/2019 |
13 | ACTIPP | Esomeprazole | 40mg | Gélule GR | B/8 | ACT PHARMA | E | N | 03/04/2019 |
* 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 | CIBLOR Enfant | Amoxicilline + Acide clavulanique |
100 mg/125mg | poudre pour suspension orale | Fl/60ml | PIERRE FABRE | E | N | 28/06/2018 |
2 | CIBLOR | Amoxicilline + Acide clavulanique |
500/62.5mg | poudre pour suspension orale | sachets B/12 | PIERRE FABRE | E | N | 28/06/2018 |
3 | CIBLOR | Amoxicilline + Acide clavulanique |
1gr/125mg | poudre pour suspension orale | sachets B/12 | PIERRE FABRE | E | N | 28/06/2018 |
4 | TAVASTOR | Atorvastatine | 40mg | Comprimé pelliculé | B/90 | TERIAK | E | N | 28/08/2018 |
5 | VILDYNE | Vidagliptine | 50mg | Comprimé pelliculé | B/60 | TAHAPHARMA | E | N | 04/10/2018 |
6 | DIABITOS | Metformine | 850 mg | Comprimé pelliculé | B/60 | SAIPH | E | N | 18/10/2018 |
7 | DIABITOS | Metformine | 850 mg | Comprimé pelliculé | B/90 | SAIPH | E | N | 18/10/2018 |
8 | OROCORT | Prednisolone | 20 mg | cp orodispersible | B/10 | SIMED | E | N | 24/10/2018 |
9 | VERMOZOL | Mebendazole | 100 mg | cp | B/6 | PHARMAGHEB | E | N | 17/12/2018 |
10 | TRIATEC | RAMIPRIL | 2.5mg | cp | B/30 | SANOFI AVENTIS PHARMA TUNISIE | E | N | 20/12/2018 |
11 | TRIATEC | RAMIPRIL | 5mg | cp | B/30 | SANOFI AVENTIS PHARMA TUNISIE | E | N | 20/12/2018 |
12 | TRIATEC | RAMIPRIL | 10 mg | cp | B/30 | SANOFI AVENTIS PHARMA TUNISIE | E | N | 20/12/2018 |
13 | VERMOZOL | Mebendazole | 500 mg | cp | B/1 | PHARMAGHEB | E | N | 25/12/2018 |
14 | PRIFAL enfant | Bromure de prifinium | 250 mg/ml | solution buvable | FL/50 ml | TERIAK | E | N | 26/12/2018 |
15 | DIAREN NOURRISSON . | RACECADOTEIL | 10 mg | Poudre pour solution orale | B/16 | PHARMAGHEB | I | N | 02/01/2019 |
16 | TRITAZIDE | RAMIPRIL + HYDROCHLOROTHIAZIDE | 10mg/12.5 mg | Cp | B/30 | SANOFI AVENTIS PHARMA TUNISIE | E | N | 08/01/2019 |
17 | TRITAZIDE | RAMIPRIL + HYDROCHLOROTHIAZIDE | 10mg/25 mg | Cp | B/30 | SANOFI AVENTIS PHARMA TUNISIE | E | N | 08/01/2019 |
18 | LEVOSTAMINE | Levocétirizine dihydrate |
5 mg | cp | B/30 | GALPHARMA | E | N | 18/01/2019 |
19 | VITACHOLINE 1.5 mg gélule B/60 | Rivastigmine | 1.5 mg | gélule | B/60 | TAHAPHARMA | E | N | 05/02/2019 |
20 | VITACHOLINE 3 mg gélule B/60 | Rivastigmine | 3 mg | gélule | B/60 | TAHAPHARMA | E | N | 05/02/2019 |
21 | VITACHOLINE | Rivastigmine | 4.5 mg | gélule | B/60 | TAHAPHARMA | E | N | 05/02/2019 |
22 | VITACHOLINE 6 mg gélule B/60 | Rivastigmine | 6 mg | gélule | B/60 | TAHAPHARMA | E | N | 05/02/2019 |
23 | FINGOLINE | Rivastigmine | 0.5 mg | gélule | B/60 | TAHAPHARMA | E | N | 05/02/2019 |
24 | ANASTRA | Anastrozole | 1 mg | cp | B/60 | TAHAPHARMA | V | N | 11/02/2019 |
25 | GLIBENCLAMIDE | GLIBENCLAMIDE | 5 mg | cp sécable | B/1600 | SIPHAT | E | N | 15/02/2019 |
26 | VITARGINE | Chlorhydrate d’arginine + chlorhydrate de thiamine + chlorhydrate de pyridoxine | 250/100/20 mg | comprimé pelliculé | B/24 | ADWYA | C | N | 20/02/2019 |
27 | HISTAM | Desloratadine | 0.5 mg /ml | sirop | FL/150 ml | PHARMAGHREB | E | V | 20/02/2019 |
28 | RIBERYN | RIBAVERINE | 200mg | cp | B/168 | NEWIX | E | N | 25/02/2019 |
29 | LEDIVIR | Sofosbuvir + Ledipasvir |
90 mg / 400 mg | comprimé pelliculé | B/30 | TAHAPHARMA | E | N | 26/02/2019 |
30 | EBUVIR 400 | Sofosbuvir | 400 mg | comprimé pelliculé | B/30 | TAHAPHARMA | E | N | 26/02/2019 |
31 | GLIPTAVIL | Vidagliptine | 50 mg | comprimé | B/30 | GALPHARMA | E | N | 27/02/2019 |
32 | ONDANSETRON MEDIS | Ondansétron | 8 mg/4 ml | solution injectable | B/5 amp/4 ml | MEDIS | V | N | 27/02/2019 |
33 | RAXIDONE | Rispéridone | 4 mg | comprimé pelliculé sécable | B/30 | SAIPH | E | N | 27/02/2019 |
34 | CIBRAMINE | Escitalopram oxalate | 10 mg | comprimé pelliculé sécable | B/28 | PHARMACARE | E | N | 27/02/2019 |
35 | CIBRAMINE | Escitalopram oxalate | 20 mg | comprimé pelliculé sécable | B/28 | PHARMACARE | E | N | 27/02/2019 |
36 | PSODERM PLUS | Calcipotriol + Bétamétasone | 50 mcg/0.5mg | gel | T/60 gr | PHARMAGHREB | E | N | 27/02/2019 |
37 | ORAPRED | Prednisolone | 5 mg | cp orodispersible | B/30 | GALPHARMA | E | N | 27/02/2019 |
38 | ORAPRED | Prednisolone | 20 mg | cp orodispersible | B/10 | GALPHARMA | E | N | 27/02/2019 |
39 | ORAPRED | Prednisolone | 20 mg | cp effervescent | B/10 | GALPHARMA | E | N | 27/02/2019 |
40 | DIARESTOP FLASH | Lopéramide | 2 mg | cp orodispersible | B/10 | ADVANS PHARMA | C | N | 27/02/2019 |
41 | ACARBOSE ADWYA | Acarbose | 50 mg | cp | B/90 | ADWYA | E | N | 28/02/2019 |
42 | ACARBOSE ADWYA | Acarbose | 100 mg | cp | B/90 | ADWYA | E | N | 28/02/2019 |
43 | CARBODIAL | Acarbose | 50 mg | cp | B/90 | NEAPOLIS | E | N | 28/02/2019 |
44 | CARBODIAL | Acarbose | 100 mg | cp | B/90 | NEAPOLIS | E | N | 28/02/2019 |
45 | SPASCARE | Phloroglucinol | 80 mg | cp oro-dispersible | B/20 | PHARMACARE | I | N | 04/03/2019 |
46 | SPASCARE | Phloroglucinol | 160 mg | cp oro-dispersible | B/10 | PHARMACARE | I | N | 04/03/2019 |
47 | AZEAL FREE | AZELASTINE | 0.05% | collyre | Fl multidose /6 ml | UNIMED | E | N | 04/03/2019 |
48 | PAREXAT | PAROXETINE | 20mg | cp pelliculé sécable | B/60 | PHARMAGHEB | E | N | 07/03/2019 |
49 | FYLCOL | FLUCONAZOLE | 150 mg | Gélule | B/12 | TAHA PHARMA | N | 07/03/2019 | |
50 | EBUVIR 400 | SOFOSBUVIR | 400 mg | Comprimé pelliculé | FL/10 | NEWIX | E | N | 12/03/2019 |
51 | DIARIX | RIFAXIMINE | 200 mg | Comprimé pelliculé | B/42 | GALPHARMA | I | N | 12/03/2019 |
52 | UROSINE 10 | ALFUZOSINE | 10 mg | Comprimé pelliculé lp | B/90 | TAHA PHARMA | I | N | 15/03/2019 |
53 | ANTISPASM | PHLOROGLUCINOL | 80 mg | Comprimé orodispersible | B/30 | TAHA PHARMA | I | N | 15/03/2019 |
54 | ADONTAG | PREGABALINE | 75 mg | Gélule | FL/14 | TAHA PHARMA | V | N | 15/03/2019 |
55 | CIPROFLEX | CIPROFLOXACINE | 750mg | cp pelliculé | B/15 | TAHA PHARMA | E | N | 01/04/2019 |
56 | SPIRACTONE | SPIRONOLACTONE | 25mg |
cp sécable | B/30 | PHARMACARE | E | N | 01/04/2019 |
57 | SPIRACTONE | SPIRONOLACTONE | 50 mg |
cp sécable | B/30 | PHARMACARE | E | N | 01/04/2019 |
58 | SPIRACTONE | SPIRONOLACTONE | 75 mg |
cp sécable | B/30 | PHARMACARE | E | N | 01/04/2019 |
59 | ROSACT | ROSUVASTATINE | 10mg |
cp pell | B/30 | ACTPHARMA | E | N | 01/04/2019 |
60 | ROSACT | ROSUVASTATINE | 20mg | cp pell | B/30 | ACTPHARMA | E | N | 01/04/2019 |
61 | DIFEN EMULGEL |
DICLOFENAC | 10 mg | Gel dermique | T/50g | PHARMADERM | C | N | 01/04/2019 |
62 | CYVAX | SALMETEROL + FLUCONAZOLE | 50µg/25µg/dose | Suspension pour inhalation | Fl/120 doses | BERG LIFE SCIENCES | E | N | 01/04/2019 |
63 | LEVOJECT | LEVOFLOXACINE | 5mg/ml | Sol inj pr perfusion | Poche/100ml | UNIMED | E | N | 03/04/2019 |
64 | LEVOJECT | LEVOFLOXACINE | 5mg/ml | Sol inj pr perfusion | B/10P/100ml | UNIMED | E | N | 03/04/2019 |
65 | TENSIOVALS 80 | VALSARTAN | 80mg | Cp pel sec | B/90 | Taha Pharma | E | N | 03/04/2019 |
66 | TENSIOVALS 160 | VALSARTAN | 80mg | Cp pel sec | B/90 | Taha Pharma | E | N | 03/04/2019 |
67 | TENSIOVALS DUO | VALSARTAN AMLODIPINE | 80mg /5mg | Cp pel sec | B/90 | Taha Pharma | E | N | 03/04/2019 |
68 | TENSIOVALS DUO | VALSARTAN AMLODIPINE | 160mg /5mg | Cp pel sec | B/90 | Taha Pharma | E | N | 03/04/2019 |
69 | TENSIOVALS DUO | VALSARTAN AMLODIPINE | 160mg /10mg | Cp pel sec | B/90 | Taha Pharma | E | N | 03/04/2019 |