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

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
Diosmin/Hesperidin (FFP) 900/100 mg Tablets 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