Current IIP-Developments, EU-Dossiers and Marketing Authorisations

Alzheimer's disease

Active Ingredient Dosage Form Strength Authorisation were granted in*)
Memantine hydrochloride film-coated tablets 5 mg, 10 mg, 15 mg, 20 mg DE
Memantine hydrochloride oral drops, solution 10 mg / g DE

Bacterial infection

Active Ingredient Dosage Form Strength Authorisation were granted in*)
Levofloxacin hemihydrate film-coated tablets 250 mg, 500 mg BE, BG, DE, FR, IT, LU, NL, PL, RO
Norfloxacin film-coated tablets 400 mg CH, DE

Depression

Active Ingredient Dosage Form Strength Authorisation were granted in*)
Paroxetine hydrochloride film-coated tablets 20 mg AT, BE, DE, DK, ES, FI, IS, NL, NO, PT, SE, UK
Trimipramine hydrogenmaleate tablets 25 mg, 100 mg DE

Diabetes mellitus II

Active Ingredient Dosage Form Strength Authorisation were granted in*)
Metformin hydrochloride film-coated tablets 500 mg, 850 mg, 1000 mg AT, BE, CZ, CH, DE, DK, EE, ES, FI, FR, GR, HU, IT, LT, LU, LV, NL, NO, PL, PT, SE, SK, UK Bestseller

Epilepsy

Active Ingredient Dosage Form Strength Authorisation were granted in*)
Levetiracetam concentrate for solution for infusion 100 mg/ml DE
Levetiracetam film-coated tablets 250 mg, 500 mg, 750 mg, 1000 mg DE, EU
Levetiracetam oral solution 100 mg/ml CH, DE, EU
Valproate sodium gastro-resistant tablets 150 mg, 300 mg, 600 mg DE, DK, NO
Valproate sodium solution fro injection 100 mg/ml
Valproate sodium oral solution 300 mg/ml DE
Valproate sodium / valproic acid prolonged-release tablets 200 mg, 300 mg, 500 mg CZ, BE, DE, FR, IT, LU, LV, NL, PL, PT, SE, UK Bestseller

Generalized anxiety, Somatoform disturbances

Active Ingredient Dosage Form Strength Authorisation were granted in*)
Opipramol dihydrochloride film-coated tablets 50 mg, 100 mg, 150 mg DE Bestseller

Hypertension, Benign prostatic hyperplasia

Active Ingredient Dosage Form Strength Authorisation were granted in*)
Terazosin hydrochloride tablets 1 mg, 2, mg, 5 mg, 10 mg AT, DE, DK, ES, FR, HU, NO, SE, UK

Hypertension, Oedema

Active Ingredient Dosage Form Strength Authorisation were granted in*)
Piretanide tablets 6 mg DE, GR

Prostate cancer

Active Ingredient Dosage Form Strength Authorisation were granted in*)
Flutamide tablets 250 mg AT, CH, DE, DK, ES, FI, FR, GR, HU, SE

Urinary incontinence

Active Ingredient Dosage Form Strength Authorisation were granted in*)
Propiverine hydrochloride film-coated tablets 5 mg, 15 mg DE, PT

Current submissions will be applied in the actual NeeS format.
For each IIP-EU-dossier an exposé is available on request.

For any further information please feel free to contact us.

*) Country codes: AT = Austria, BE = Belgium, BG = Bulgaria, CH = Switzerland, CZ = Czech Republic, DE = Germany, DK = Denmark, EE = Estonia, EU = European Union, ES = Spain, FI = Finland, FR = France, GR = Greece, HU = Hungary, IT = Italy, IS = Iceland, LT = Lithuania, LU = Luxembourg, LV = Latvia, NL = Netherlands, NO = Norway, PL = Poland, PT = Portugal, RO = Romania, SE = Sweden, SK = Slovakia, UK = United Kingdom
We expressively point out that these dossiers or marketing authorisations cannot be used in countries where the medicinal products are protected by intellectual property rights.
www.iip.de © Institut für industrielle Pharmazie Forschungs- und Entwicklungsgesellschaft mbH