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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 		Oral solution (Stick Pack) 2014
Analgesics
 Paracetamol 500 mg
650 mg
1 g 		Tablets 2005
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
Analgesics
 Fentanyl 100 mcg
200 mcg
300 mcg
400 mcg
600 mcg
800 mcg 		Sublingual tablets 2017
Antifungals
 Ketoconazole 20 mg/g Cream 2017
Antifungals
 Ketoconazole 20 mg/g Cream 2017
Antiinfectives
 Clarithromycin 250 mg
500 mg 		Film-coated tablets 2001
Antiinfectives
 Clarithromycin 250 mg
500 mg 		Film-coated tablets 2001
Antiinfectives
 Azithromycin 500 mg Film-coated tablets 2000
Antiinfectives
 Azithromycin 500 mg Film-coated tablets 2000
Antiinflamatories
 Ibuprofen 400 mg
600 mg 		Film-coated tablets 2001
Antiinflamatories
 Ibuprofen 400 mg
600 mg 		Film-coated tablets 2001
Antiinflamatories
 Diclofenac 11.6 mg/g Gel 2008
Antiinflamatories
 Diclofenac 11.6 mg/g Gel 2008
Antiinflamatories
 Dexamethasone
(with preservatives) 		4 mg/ml Solution for injection 2019
Antiinflamatories
 Dexamethasone
(with preservatives) 		4 mg/ml Solution for injection 2019
Antiinflamatories
 Diclofenac 23.2 mg/g Gel 2019
Antiinflamatories
 Diclofenac 23.2 mg/g Gel 2019
Antiinflamatories
 Prednisone 5 mg
10 mg
30 mg 		Tablets 2004
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 200 mg
400 mg
600 mg 		Oral suspension (Stick Pack) 2014
C.N.S.
 Memantine 10 mg
20 mg 		Tablets 2010
C.N.S.
 Sulpiride 50 mg Capsules 2005
C.N.S.
 Memantine 10 mg
20 mg 		Tablets 2010
C.N.S.
 Sulpiride 50 mg Capsules 2005
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.
 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
C.N.S.
 Naloxone 0.4 mg/ml Solution for injection 2010
C.N.S.
 Betahistine 24 mg
8 mg
16 mg 		Tablets 2019
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 5 mg
10 mg
15 mg
30 mg 		Tablets 2014
C.N.S.
 Aripiprazole 1 mg/ml Oral solution 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.
 Pregabalin 25 mg
50 mg
75 mg
100 mg
150 mg
200 mg
300 mg 		Capsules 2011
C.N.S.
 Lorazepam 1 mg
2.5 mg
5 mg 		Tablets 2014
C.N.S.
 Pregabalin 25 mg
50 mg
75 mg
100 mg
150 mg
200 mg
300 mg 		Capsules 2011
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.
 Lormetazepam 0.5 mg
1 mg
2 mg 		Tablets 2008
C.N.S.
 Bromazepam 1.5 mg
3 mg 		Capsules 2008
Cardiovascular
 Propranolol 10 mg
40 mg 		Tablets 2017
Cardiovascular
 Propranolol 10 mg
40 mg 		Tablets 2017
Cardiovascular
 Irbesartan 75 mg
150 mg
300 mg 		Film-coated tablets 2008
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
 Digoxin 0.25 mg/ml (2ml) Solution for injection 2010
Cardiovascular
 Irbesartan/HCTZ 150/12.5 mg
300/12.5 mg
300/25 mg 		Film-coated tablets 2009
Cardiovascular
 Digoxin 0.25 mg/ml (2ml) Solution for injection 2010
Cardiovascular
 Labetalol 5 mg/ml Solution for injection 2010
Cardiovascular
 Ambrisentan 5 mg
10 mg 		Tablets 2018
Cardiovascular
 Digoxin 0.25 mg Tablets 2010
Cardiovascular
 Labetalol 5 mg/ml Solution for injection 2010
Cardiovascular
 Ambrisentan 5 mg
10 mg 		Tablets 2018
Cardiovascular
 Digoxin 0.25 mg Tablets 2010
Cardiovascular
 Furosemida 40 mg Tablets 2004
Cardiovascular
 Furosemida 40 mg Tablets 2004
Cardiovascular
 Rosuvastatin 5 mg
10 mg
20 mg
40 mg 		Film-coated tablets 2014
Cardiovascular
 Rosuvastatin 5 mg
10 mg
20 mg
40 mg 		Film-coated tablets 2014
Contraceptives
 Etonogestrel Ethinylestradiol 0.120 mg
0.015 mg
(per 24 hours) 		Vaginal delivery system 2017
Contraceptives
 Etonogestrel Ethinylestradiol 0.120 mg
0.015 mg
(per 24 hours) 		Vaginal delivery system 2017
Musculoskeletal
 Chondroitin sulfate 400 mg Capsules 2014
Musculoskeletal
 Vitamin D3 2,000 IU/ml Oral solution 2019
Musculoskeletal
 Chondroitin sulfate 400 mg Capsules 2014
Musculoskeletal
 Vitamin D3 2,000 IU/ml Oral solution 2019
Musculoskeletal
 Vitamin D3 25,000 IU/ml Oral solution 2019
Musculoskeletal
 Vitamin D3 25,000 IU/ml Oral solution 2019
Oncology
 Imatinib 100 mg
400 mg 		Film-coated tablets 2014
Oncology
 Imatinib 100 mg
400 mg 		Film-coated tablets 2014
Oncology
 Letrozole 2.5 mg Tablets 2007
Oncology
 Letrozole 2.5 mg Tablets 2007
Oral Antidiabetics
 Vildagliptin 50 mg Tablets 2016
Oral Antidiabetics
 Vildagliptin 50 mg Tablets 2016
Oral Antidiabetics
 Vildagliptin/Metformin 50/850 mg
50/1000 mg 		Film-coated tablets 2019
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
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
Respiratory System
 Cold relief capsules Parecetamol
Chlorphenamine
Dextromethorphan
Pseudoephedrine 		500 mg
2 mg
15 mg
30 mg 		Capsules 2019
Urology
 Solifenacin 5 mg
10 mg 		Film-coated tablets 2017
Urology
 Tadalifo 5 mg
10 mg
20 mg 		Film-coated tablets 2017
Urology
 Solifenacin 5 mg
10 mg 		Film-coated tablets 2017
Urology
 Tadalifo 5 mg
10 mg
20 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) 450/50 mg Tablets 2017
Venous System
 Diosmin/Hesperidin 450/50 mg Tablets 2008
Venous System
 Diosmin/Hesperidin (FFP) 900/100 mg Tablets 2019
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
Gastrointestinal
 Metoclopramide 1mg/ml Oral solution (Flask) Q3 2020
Musculoskeletal
 Naproxen sodium 550 mg Film-coated tablets Q1 2020
Musculoskeletal
 Naproxen sodium 550 mg Film-coated tablets Q1 2020
Musculoskeletal
 Vitamin D3 20.000 IU
 Soft capsules Q2 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
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
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
Venous System
 Rivaroxaban 10 mg
15 mg
20 mg 		Film-coated tablets Q1 2022