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Product List CTD – Medicinal Product Auditable & Routine

Therapeutical area Product Dose Pharmaceutical form Date of Dossier Development Editar producto
Analgesics
Paracetamol 500 mg
650 mg
1 g
Oral solution (Stick Pack) 2014
Analgesics
Paracetamol 500 mg
650 mg
1 g
Tablets 2005
Analgesics
Fentanyl 100 mcg
200 mcg
300 mcg
400 mcg
600 mcg
800 mcg
Sublingual tablets 2017
Antifungals
Ketoconazole 20 mg/g Cream 2017
Antiinfectives
Azithromycin 500 mg Film-coated tablets 2000
Antiinfectives
Clarithromycin 250 mg
500 mg
Film-coated tablets 2001
Antiinflamatories
Dexamethasone
(with preservatives)
4 mg/ml Solution for injection 2019
Antiinflamatories
Diclofenac 23.2 mg/g Gel 2019
Antiinflamatories
Prednisone 5 mg
10 mg
30 mg
Tablets 2004
Antiinflamatories
Ibuprofen 200 mg
400 mg
600 mg
Oral suspension (Stick Pack) 2014
Antiinflamatories
Ibuprofen 400 mg
600 mg
Film-coated tablets 2001
Antiinflamatories
Diclofenac 11.6 mg/g Gel 2008
C.N.S.
Pregabalin 25 mg
50 mg
75 mg
100 mg
150 mg
200 mg
300 mg
Capsules 2011
C.N.S.
Sulpiride 50 mg Capsules 2005
C.N.S.
Betahistine 24 mg
8 mg
16 mg
Tablets 2019
C.N.S.
Aripiprazole 5 mg
10 mg
15 mg
30 mg
Tablets 2014
C.N.S.
Aripiprazole 1 mg/ml Oral solution 2014
C.N.S.
Lorazepam 1 mg
2.5 mg
5 mg
Tablets 2014
C.N.S.
Lormetazepam 0.5 mg
1 mg
2 mg
Tablets 2008
C.N.S.
Bromazepam 1.5 mg
3 mg
Capsules 2008
C.N.S.
Memantine 10 mg
20 mg
Tablets 2010
C.N.S.
Memantine 10 mg/ml Oral solution 2010
C.N.S.
Diazepam 2.5 mg
5 mg
10 mg
25 mg
Tablets 2010
C.N.S.
Naloxone 0.4 mg/ml Solution for injection 2010
Cardiovascular
Digoxin 0.25 mg/ml (2ml) Solution for injection 2010
Cardiovascular
Digoxin 0.25 mg Tablets 2010
Cardiovascular
Furosemida 40 mg Tablets 2004
Cardiovascular
Rosuvastatin 5 mg
10 mg
20 mg
40 mg
Film-coated tablets 2014
Cardiovascular
Propranolol 10 mg
40 mg
Tablets 2017
Cardiovascular
Irbesartan 75 mg
150 mg
300 mg
Film-coated tablets 2008
Cardiovascular
Irbesartan/HCTZ 150/12.5 mg
300/12.5 mg
300/25 mg
Film-coated tablets 2009
Cardiovascular
Labetalol 5 mg/ml Solution for injection 2010
Cardiovascular
Ambrisentan 5 mg
10 mg
Tablets 2018
Contraceptives
Etonogestrel Ethinylestradiol 0.120 mg
0.015 mg
(per 24 hours)
Vaginal delivery system 2017
Musculoskeletal
Vitamin D3 2,000 IU/ml Oral solution 2019
Musculoskeletal
Vitamin D3 25,000 IU/ml Oral solution 2019
Musculoskeletal
Chondroitin sulfate 400 mg Capsules 2014
Oncology
Imatinib 100 mg
400 mg
Film-coated tablets 2014
Oncology
Letrozole 2.5 mg Tablets 2007
Oral Antidiabetics
Vildagliptin 50 mg Tablets 2016
Oral Antidiabetics
Vildagliptin/Metformin 50/850 mg
50/1000 mg
Film-coated tablets 2019
Oral Antidiabetics
Sitagliptin/Metformin 50/850 mg
50/1000 mg
Film-coated tablets 2019
Respiratory System
Cold relief capsules Parecetamol
Chlorphenamine
Dextromethorphan
Pseudoephedrine
500 mg
2 mg
15 mg
30 mg
Capsules 2019
Urology
Tadalifo 5 mg
10 mg
20 mg
Film-coated tablets 2017
Urology
Solifenacin 5 mg
10 mg
Film-coated tablets 2017
Venous System
Diosmin/Hesperidin (FFP) 450/50 mg Tablets 2017
Venous System
Diosmin/Hesperidin 450/50 mg Tablets 2008
Venous System
Diosmin/Hesperidin (FFP) 900/100 mg Tablets 2019

List CTD Drug Product Under Development

Therapeutical area Product Dose Pharmaceutical form Date of Dossier Development Editar producto
Gastrointestinal
Metoclopramide 1mg/ml Oral solution (Flask) Q3 2020
Musculoskeletal
Naproxen sodium 550 mg Film-coated tablets Q1 2020
Musculoskeletal
Vitamin D3 20.000 IU
Soft capsules Q2 2020
Oral Antidiabetics
Sitagliptin 25 mg
50 mg
100 mg
Film-coated tablets Q3 2020
Respiratory System
Hedera Helix Syrup 35mg/5ml Oral solution (Stick pack & Flask) Q4 2020
Venous System
Rivaroxaban 10 mg
15 mg
20 mg
Film-coated tablets Q1 2022