Enoxaparin

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Articles

Lactation Safety Information

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Limited published evidence of safety
Low levels anticipated in milk due to the drug’s properties and not absorbed from the infant’s GI tract
Used in full-term neonates from birth
20th October 2016

New Medicines

Arovi · Thromboembolic disorders including DVT, myocardial infarction, unstable angina

Information

Arovi
Biosimilar
Rovi
Not Known

Development and Regulatory status

Launched
Launched
Pre-registration (Filed)
March 2018
Jul 18 · ROVI announces that it is changing the name of Enoxaparin Becat to Arovi, at the request of the MHRA. Both products are identical, and the only difference is in the packaging. ROVI will launch to the UK market two new presentations, 120mg and 150mg [6].
Mar 18 · Lower strengths have been launched in the UK; cost for 10 x 20mg/0.2ml syringes = £20.86, 10 x 40mg/0.4ml syringes = £30.27, 10 x 60mg/0.6ml syringes = £39.26, 10 x 80mg/0.8ml syringes = £55.13, 10 x 100mg/1ml syringes = £72.30. The 120mg/0.8ml and 150mg/1ml syringes are expected to launch later in the year [5].
Mar 17 · Approved in the UK as Enoxaparin Becat or Crusia [4].
Mar 17 · EU positive opinion via the decentralised procedure. Germany acted as Reference Member State (RMS). The national phase of the registration process is expected to be completed with the granting by the competent local authorities of the marketing authorisation in each concerned country. This national phase could last from three to ten months [3].
Aug 16 · Remains under regulatory review in EU. A decision on approval is expected in 2016 [2].
Nov 14 · In 2014, Rovi filed in the EU. As of mid-2015, the company is working on a list of objections and questions raised by the EU authorities. Similar drug application was also filed with the US FDA [1].

Category

Factor Xa inhibitor
Thromboembolic disorders including DVT, myocardial infarction, unstable angina
Subcutaneous injection

Trial or other data

Mar 16 · The EMA considers enoxaparin sodium to be a biologic, whereas the US FDA has approved an application for the generic version of enoxaparin (Sandoz-Momenta Pharmaceuticals) in 2010 [1].

Evidence based evaluations