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Product List CTD – Medicinal Product Auditable

Therapeutical area Product Dose Pharmaceutical form Date of dossier development Editar producto
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 During 2014-2017
Analgesics
Paracetamol 500 mg
650 mg
1 g
Oral solution Before 2014
Antifungals
Ketoconazole 20 mg/g Cream During 2014-2017
Antifungals
Voriconazole 50 mg
200 mg
Film-coated tablets During 2014-2017
Antiinfectives
Clarithromycin 250 mg
500 mg
Film-coated tablets 2001
Antiinfectives
Aciclovir 5% Cream 1999
Antiinfectives
Azithromycin 500 mg Film-coated tablets 2000
Antiinflamatories
Ibuprofen 200 mg
400 mg
600 mg
Oral suspension 2014
Antiinflamatories
Ibuprofen 400 mg
600 mg
Film-coated tablets 2001
Antiinflamatories
Prednisone 5 mg
10 mg
30 mg
Tablets 2004
Antiinflamatories
Diclofenac 11.6 mg/g Gel 2008
Antiinflamatories
Dexamethasone
(with preservatives)
4 mg/ml Solution for injection During 2014-2017
Antiinflamatories
Diclofenac 23.2 mg/g Gel During 2014-2017
C.N.S.
Diazepam 2.5 mg
5 mg
10 mg
25 mg
Tablets 1964
C.N.S.
Lorazepam 1 mg
2.5 mg
5 mg
Tablets 1 mg: 2007
2 mg and 5 mg: 2014
C.N.S.
Aripiprazole 5 mg
10 mg
15 mg
30 mg
Tablets 2012
C.N.S.
Lormetazepam 0.5 mg
1 mg
2 mg
Tablets 2008
C.N.S.
Aripiprazole 1 mg/ml Oral solution 2014
C.N.S.
Pregabalin 25 mg
50 mg
75 mg
100 mg
150 mg
200 mg
300 mg
Capsules 2011
C.N.S.
Memantine 10 mg
20 mg
Tablets 2010
C.N.S.
Memantine 10 mg/ml Oral solution 2010
C.N.S.
Betahistine 8 mg
16 mg
Tablets 2009
C.N.S.
Sulpiride 50 mg Capsules 2005
C.N.S.
Naloxone 0.4 mg/ml Solution for injection 1979
C.N.S.
Bromazepam 1.5 mg
3 mg
Capsules 2008
Cardiovascular
Digoxin 0.25 mg/ml (2ml) Solution for injection 1960
Cardiovascular
Irbesartan 75 mg
150 mg
300 mg
Film-coated tablets 2008
Cardiovascular
Rosuvastatin 5 mg
10 mg
20 mg
40 mg
Film-coated tablets Before 2014
Cardiovascular
Digoxin 0.25 mg Tablets 1960
Cardiovascular
Irbesartan/HCTZ 150/12.5 mg
300/12.5 mg
300/25 mg
Film-coated tablets 2009
Cardiovascular
Propranolol 10 mg
40 mg
Tablets During 2014-2017
Cardiovascular
Labetalol 5 mg/ml Solution for injection 1981
Cardiovascular
Acetylsalicylic acid 100 mg Gastro-resistant tablets 2010
Cardiovascular
Furosemida 40 mg Tablets 2004
Dermatology
Mupirocin 20 mg/g Ointment During 2014-2017
Immunosuppressants
Valganciclovir 450 mg Tablets Before 2014
Musculoskeletal
Chondroitin sulfate 400 mg Capsules Before 2014
Musculoskeletal
Vitamin D3 10,000 IU/ml Oral solution During 2014-2017
Musculoskeletal
Tadalafil 5 mg
10 mg
20 mg
Film-coated tablets During 2014-2017
Musculoskeletal
Sildenafil 20 mg Film-coated tablets Before 2014
Oncology
Letrozole 2.5 mg Tablets 2007
Oncology
Imatinib 100 mg
400 mg
Film-coated tablets 2014
Oral Antidiabetics
Vildagliptin 50 mg Tablets During 2014-2016
Respiratory System
Fenspiride 2 mg/ml Oral solution During 2014-2017
Respiratory System
Linezolid 600 mg Film-coated tablets During 2014-2017
Respiratory System
Fenspiride 80 mg Tablets During 2014-2017
Urology
Solifenacin 5 mg
10 mg
Film-coated tablets During 2014-2017
Venous System
Diosmin/Hesperidin (FFP) 450/50 mg Tablets During 2014-2017
Venous System
Diosmin/Hesperidin 450/50 mg Tablets 2008

List CTD Drug Product Under Development

Therapeutical area Product Dose Pharmaceutical form Date of dossier development Editar producto
Antiinflamatories
Dexamethasone
(without preservatives)
4 mg/ml Solution for injection Q1 2019
C.N.S.
Betahistine 24 mg Tablets Q3 2018
C.N.S.
Fingolimod 0.5 mg Capsules Q1 2019
Cardiovascular
Ambrisentan 5 mg
10 mg
Tablets Q3 2018
Dermatology
Calcipotriol/Betametasone 50 mcg/g + 0,5 mg/g Ointment Q3 2019
Gastrointestinal
Metoclopramide 1mg/ml Oral solution Q3 2019
Immunosuppressants
Tacrolimus 0.1%
0.03%
Ointment Q4 2019-Q2 2020
Musculoskeletal
Vitamin D3 20.000 IU
40.000 IU
Soft capsules Q2 2019
Musculoskeletal
Vitamin D3 2,000 IU/ml Oral solution Q4 2018
Musculoskeletal
Vitamin D3 10,000 IU/ml Oral solution Q4 2018
Q1 2019
Musculoskeletal
Naproxen sodium 550 mg Film-coated tablets Q2 2019
Oral Antidiabetics
Sitagliptin 25 mg
50 mg
100 mg
Film-coated tablets Q2 2020
Oral Antidiabetics
Sitagliptin/Metformin 50/850 mg
50/1000 mg
Film-coated tablets Q4 2020
Oral Antidiabetics
Vildagliptin/Metformin 50/850 mg
50/1000 mg
Film-coated tablets Q3 2019
Respiratory System
Cold relief capsules
Paracetamol
Chlorphenamine
Dextromethorphan
Pseudoephedrine
500 mg
2 mg
15 mg
30 mg
Capsules Q1-2019
Venous System
Diosmin/Hesperidin (FFP) 900/100 mg Tablets Q1 2019