Dossiers d'AMM à étudier par le Comité Technique des Spécialités Pharmaceutiques du 03/01/2020.
Pour ce comité technique, l’ordre de passage des dossiers sera comme suit .
Spécialités Pharmaceutiques importées :
* Produits déjà évalués lors des derniers Comités Techniques
N° | Médicament | DCI | Dosage | Forme Pharmaceutique | Présentation | TITULAIRE | VEIC | Type de demande | DATE Rapport |
1 | CARBODIAL | Acarbose | 50 mg | cp | B/90 | NEAPOLIS | E | N | 02/12/2019 |
2 | CARBODIAL | Acarbose | 100 mg | cp | B/90 | NEAPOLIS | E | N | 02/12/2019 |
3 | LEVOJECT | LEVOFLOXACINE | 5mg/ml | Sol inj pr perfusion | B/10P/100ml | UNIMED | E | N | 04/12/2019 |
4 | METROJECT | Metronidazole | 0.5% | solution injectable | B/25 poches multicouches | UNIMED | E | N | 11/12/2019 |
5 | ESOCALM | Esoméprazole | 20 mg | Gélule gastrorésistante | B/7 | ADVANS | E | N | 09/12/2019 |
6 | ESOCALM | Esoméprazole | 20mg | Gélule gastrorésistante | B/14 | ADVANS | E | N | 09/12/2019 |
7 | ESOCALM | Esoméprazole | 20mg | Gélule gastrorésistante | B/28 | ADVANS | E | N | 09/12/2019 |
8 | ESOCALM | Esoméprazole | 40mg | Gélule gastrorésistante | B/7 | ADVANS | E | N | 09/12/2019 |
9 | ESOCALM | Esoméprazole | 40mg | Gélule gastrorésistante | B/14 | ADVANS | E | N | 09/12/2019 |
10 | ESOCALM | Esoméprazole | 40mg | Gélule gastrorésistante | B/28 | ADVANS | E | N | 09/12/2019 |
11 | FDG SISORA | Flurodésoxyglucose | 450 mbq/ml |
sol inj | Fl/15 ml | SISORA | E | N | 09/12/2019 |
12 | IBURHUME | Ibuprofène + pseudoephedrine | 200 mg/30mg | Cp péll | B/20 | PHARMACARE | E | N | 12/12/2019 |
13 | ZOMAX | Azithromycine | 1500 40mg/ml | Poudre pour suspension orale | flacon de 37.5 ml | IBN ALBAYTAR | E | N | 04/12/2019 |
14 | ROSUVASCOR | Rosuvastatine | 5 mg | cp pel | B/30 | ADWYA | E | N | 20/12/2019 |
15 | ROSUVASCOR | Rosuvastatine | 10mg | cp pel | B/30 | ADWYA | E | N | 20/12/2019 |
16 | ROSUVASCOR | Rosuvastatine | 20mg | cp pel | B/30 | ADWYA | E | N | 20/12/2019 |
17 | SPASMOSTOP | Phloroglucinol | 160 mg | comprimé orodispersible | B/10 | ADVANS PHARMA | I | N | 27/12/2019 |
* 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 | AUGMENTIN | Amoxicilline + Acide clavulanique |
1g/125 mg | poudre pour suspension orale | B/24 | ADWYA | E | N | 16/11/2019 |
2 | HALIDOL | Halopéridol | 5 mg | comprimé | B/30 | PHARMAGHREB | E | V | 25/11/2019 |
3 | HALIDOL | Halopéridol | 2 mg/ml | gouttes buvables | B/30 ml | PHARMAGHREB | E | V | 25/11/2019 |
4 | HALIDOL | Halopéridol | 2 mg/ml | gouttes buvables | B/100 ml | PHARMAGHREB | E | V | 25/11/2019 |
5 | NEURODOL | Halopéridol | 0.2% | gouttes buvables | FL/30ml | OPALIAPHARMA | E | V | 25/11/2019 |
6 | NEURODOL | Halopéridol | 0.2% | gouttes buvables | FL/100 ml | OPALIAPHARMA | E | V | 25/11/2019 |
7 | SOLOTIK | Sertraline | 100 mg | comprimé pelliculé sécable | Fl/15 | IBN ALBAYTAR | E | V | 25/11/2019 |
8 | LEVET | Levatiracetam | 100 mg/ml | solution buvable | FL/300 ml | SIMED | E | V | 25/11/2019 |
9 | TANAKAN | Ginko biloba | 40 mg | comprimé enrobé | B/30 | TERIAK | I | V | 24/11/2019 |
10 | TANAKAN | Ginko biloba | 40 mg | comprimé enrobé | B/90 | TERIAK | I | V | 25/11/2019 |
11 | TANAKAN | Ginko biloba | 4% | gouttes buvables | Fl/30 ml | TERIAK | I | V | 25/11/2019 |
12 | LEVOPROMAZINE | Levopromazine | 100 mg | comprimé enrobé | B/20 | SIPHAT | E | V | 25/11/2019 |
13 | LEVOPROMAZINE | Levopromazine | 100 mg | comprimé enrobé | B/500 | SIPHAT | E | V | 28/11/2019 |
14 | URBANYL | Clobazam | 10 mg | comprimé sécable | B/30 | Winthrop-Tunisie | I | V | 25/11/2019 |
15 | LANZOR | Lanzoprazole | 15 mg | gélule GR | B/7 | Winthrop-Tunisie | E | V | 26/11/2019 |
16 | LANZOR | Lanzoprazole | 15 mg | gélule GR | B/14 | Winthrop-Tunisie | E | V | 26/11/2019 |
17 | LANZOR | Lanzoprazole | 30 mg | gélule GR | B/15 | Winthrop-Tunisie | E | V | 26/11/2019 |
18 | LANZOR | Lanzoprazole | 30 mg | gélule GR | B/30 | Winthrop-Tunisie | E | V | 26/11/2019 |
19 | INIPRAZOL | Lanzoprazole | 15 mg | gélule | B/8 | West-Pharma | E | V | 26/11/2019 |
20 | INIPRAZOL | Lanzoprazole | 15 mg | gélule | B/14 | West-Pharma | E | V | 26/11/2019 |
21 | PRADIS | Métoclopramide | 10 mg | suppositoire | B/10 | Opalia Pharma | E | V | 26/11/2019 |
22 | SUPERSTAT | Rosuvastatine | 5 mg | comprimé pelliculé | B/30 | IBN ALBAYTAR | E | V | 26/11/2019 |
23 | CAMYSTEN | clomitrazole | 1% | crème dermique | T/30 | Opalia Pharma | E | V | 26/11/2019 |
24 | IPPROTON PERFUSION | Oméprazole | 40 mg | poudre injectable | B/1 flacon | MEDIS | E | V | 26/11/2019 |
25 | NOVACLAV | Amoxicilline + Acide clavulanique |
1gr/125mg | suspension orale | B/30 | ADWYA | E | N | 20/12/2019 |
26 | GENTA | Gentamicine | 10mg/ml | solution injectable | B/5 | MEDIS | E | V | 20/12/2019 |
27 | GENTA | Gentamicine | 10mg/ml | solution injectable | B/50 | MEDIS | E | V | 20/12/2019 |
28 | GENTA | Gentamicine | 160mg/ml | solution injectable | B/50 | MEDIS | E | V | 20/12/2019 |
29 | CIDOMYCINE 20 mg | Gentamicine | 20 mg | solution injectable | B/5 | SAIPH | E | V | 20/12/2019 |
30 | CIDOMYCINE 40 mg | Gentamicine | 40 mg | solution injectable | B/5 | SAIPH | E | V | 20/12/2019 |
31 | CIDOMYCINE 80 mg | Gentamicine | 80 mg | solution injectable | B/5 | SAIPH | E | V | 20/12/2019 |
32 | CIDOMYCINE 80 mg | Gentamicine | 80 mg | solution injectable | B/5 | SAIPH | E | V | 20/12/2019 |
33 | CIPRO | Ciprofloxacine | 200mg /100ml | solution injectable | FL /100 ml | MEDIS | E | V | 20/12/2019 |
34 | CIFLOXET | Ciprofloxacine | 200mg /100ml | solution injectable | FL /100 ml | DORCAS | E | V | 20/12/2019 |
35 | CIFLOXET | Ciprofloxacine | 200mg /100ml | solution injectable | B/6 /FL/100ml | DORCAS | E | V | 20/12/2019 |
36 | CIPRO | Ciprofloxacine | 500 mg | cp enrobé | B/14 | MEDIS | E | V | 20/12/2019 |
37 | CIPRO | Ciprofloxacine | 750mg | cp enrobé | B/14 | MEDIS | E | V | 20/12/2019 |
38 | OFLOCET | Ofloxacine | 200 mg | comprimé pelliculé | B/10 | Sanofi Aventis Pharma | E | V | 20/12/2019 |
39 | OFLOCET | Ofloxacine | 200 mg | comprimé pelliculé | B/14 | Sanofi Aventis Pharma | E | V | 20/12/2019 |
40 | SPIRA | Spiramycine | 3UI | cp pelliculé | B/10 | SIPHAT | E | V | 20/12/2019 |
41 | SPIRA | Spiramycine | 3UI | cp pelliculé | B/500 | SIPHAT | E | V | 20/12/2019 |
42 | LEXIN | Cefalexine | 1GR | comprimé pelliculé | B/12 | MEDICEF | E | V | 20/12/2019 |
43 | RIFOCINE | Rifamycine | 250 mg | solution injectable | B/1 flacon | Sanofi | E | V | 20/12/2019 |
44 | PENAMOX | Amoxicilline | 500 mg | gélule | B/ 24. | MEDICEF | E | V | 20/12/2019 |
45 | PENAMOX | Amoxicilline | 500mg | gélule | B/ 400 | MEDICEF | E | V | 20/12/2019 |
46 | PENAMOX | Amoxicilline | 1 gr | comprimé sécable | B/12 | MEDICEF | E | V | 20/12/2019 |
47 | PENAMOX | Amoxicilline | 250 mg | suspension buvable | 1 FL | MEDICEF | E | V | 20/12/2019 |
48 | PENAMOX | Amoxicilline | 500 mg | suspension buvable | 1 FL | MEDICEF | E | V | 20/12/2019 |
49 | FLUTICA | Fluticasone propionate | 50 mcgr | Spray nasal | 1FL /120 doses | SAIPH | E | N | 27/12/2019 |
50 | ALLERGOSONE | Bétaméthasone | 2 mg | comprimé dispersible sécable | B/20 | Opalia Pharma | E | N | 30/12/2019 |
51 | RHINOGRIP | Paraétamol +phéniramine +Vitamine C | Granulés pour pour suspension buvable | B/12 | SAIPH | E | N | 02/01/2020 |