Overview
The marketing authorisation for Thorinane has lapsed because it has not been marketed in the European Union in the three years following the granting of the authorisation.
Thorinane : EPAR - Summary for the public
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Product information
Thorinane : EPAR - Product Information
English (EN) (3.77 MB - PDF)
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latviešu valoda (LV) (5.64 MB - PDF)
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português (PT) (3.21 MB - PDF)
română (RO) (3.55 MB - PDF)
slovenčina (SK) (5.69 MB - PDF)
slovenščina (SL) (5.41 MB - PDF)
Suomi (FI) (3.34 MB - PDF)
svenska (SV) (3.23 MB - PDF)
Latest procedure affecting product information: T/0003
05/09/2017
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Thorinane : EPAR - All Authorised presentations
English (EN) (480.85 KB - PDF)
български (BG) (506.81 KB - PDF)
español (ES) (463.14 KB - PDF)
čeština (CS) (528.54 KB - PDF)
dansk (DA) (484.14 KB - PDF)
Deutsch (DE) (486.14 KB - PDF)
eesti keel (ET) (460.2 KB - PDF)
ελληνικά (EL) (519.17 KB - PDF)
français (FR) (463.22 KB - PDF)
hrvatski (HR) (466.95 KB - PDF)
íslenska (IS) (459.6 KB - PDF)
italiano (IT) (460.12 KB - PDF)
latviešu valoda (LV) (490.85 KB - PDF)
lietuvių kalba (LT) (477.9 KB - PDF)
magyar (HU) (485.97 KB - PDF)
Malti (MT) (491.95 KB - PDF)
Nederlands (NL) (459.74 KB - PDF)
norsk (NO) (459.36 KB - PDF)
polski (PL) (489.46 KB - PDF)
português (PT) (461.42 KB - PDF)
română (RO) (480.21 KB - PDF)
slovenčina (SK) (487.86 KB - PDF)
slovenščina (SL) (479.16 KB - PDF)
Suomi (FI) (459.6 KB - PDF)
svenska (SV) (461.33 KB - PDF)
Product details
- Name of medicine
- Thorinane
- Active substance
- enoxaparin sodium
- International non-proprietary name (INN) or common name
- enoxaparin sodium
- Therapeutic area (MeSH)
- Venous Thromboembolism
- Anatomical therapeutic chemical (ATC) code
- B01AB05
Pharmacotherapeutic group
Antithrombotic agentsTherapeutic indication
Thorinane is indicated for adults for:
- Prophylaxis of venous thromboembolism, particularly in patients undergoing orthopaedic, general or oncological surgery.
- Prophylaxis of venous thromboembolism in patients bedridden due to acute illnesses including acute heart failure, acute respiratory failure, severe infections, as well as exacerbation of rheumatic diseases causing immobilisation of the patient (applies to strengths of 40 mg/0.4 mL).
- Treatment of deep vein thrombosis (DVT), complicated or uncomplicated by pulmonary embolism.
- Treatment of unstable angina and non Q wave myocardial infarction, in combination with acetylsalicylic acid (ASA).
- Treatment of acute ST segment elevation myocardial infarction (STEMI) including patients who will be treated conservatively or who will later undergo percutaneous coronary angioplasty (applies to strengths of 60 mg/0.6 mL, 80 mg/0.8 mL, and 100 mg/1 mL).
- Blood clot prevention in the extracorporeal circulation during haemodialysis.
Prevention and treatment of various disorders related to blood clots in adults.
Authorisation details
- EMA product number
- EMEA/H/C/003795
Biosimilar
This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.
- Marketing authorisation holder
- Pharmathen S.A.
Techdow Pharma Netherlands B. V.
Strawinskylaan 1143, Toren C-11
1077XX Amsterdam
Netherlands - Opinion adopted
- 20/07/2016
- Marketing authorisation issued
- 14/09/2016
- Revision
- 2
Assessment history
Thorinane : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (523.92 KB - PDF)
Thorinane : EPAR - Public assessment report
English (EN) (1.82 MB - PDF)
CHMP summary of positive opinion for Thorinane
English (EN) (532.74 KB - PDF)
News on Thorinane
Related content
- Biosimilar medicines
- Clinical data (initial marketing authorisation)
More information on Thorinane
Public statement on Thorinane: Cessation of validity of the marketing authorisation in the European Union
English (EN) (95.9 KB - PDF)