Medicinal products

Draft Order prohibiting the export of certain medicinal products

I. The export of the following medicinal products authorised for use pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency and medicinal products, which have received permission for use pursuant to Article 26(1) of the Act on Medicinal Products for Human Use shall be prohibited:

Heparin Heparin-Natrium, Solution for injection, 25 000 IU/5 ml - 5 ml, -, Pack: 1 B.Braun Melsungen AG, Germany B.Braun Melsungen AG - Germany
Heparin Heparinum WZF, Solution for injection, 5000IU/ml – 5 ml, IU, Pack: 10 Warsaw Pharmaceutical Works Polfa S.A., Poland Warsaw Pharmaceutical Works Poland
Enoxaparin Clexane, Solution for injection, 100 mg/ml – 0.4 ml (4 000 IU), -, Pack: 6 pre-filled syringes Sanofi Bulgaria EOOD, Bulgaria
Sanofi Winthrop Industrie -Maison Alfort, France; Sanofi Wintrop Industrie Le Trait, France; Chinoin
Pharmaceutical and Chemical Private, Csanyikvolgy, Hungary; Sanofi-Aventis Private Co. Ltd, Budapest, Hungary; Sanofi-Aventis GmbH, Vienna, Austria
Enoxaparin Clexane, Solution for injection, 60 mg/0.6 ml (6 000 IU), -, Pack: 6 pre-filled syringes Sanofi Bulgaria
EOOD, Bulgaria Sanofi Winthrop Industrie -Maison Alfort, France; Sanofi Wintrop Industrie Le Trait, France;
Chinoin Pharmaceuticaland Chemical Private, Csanyikvolgy, Hungary
Enoxaparin Clexane, Solution for injection, 80 mg/0.8 ml (8 000 IU), -, Pack: 6 pre-filled syringes Sanofi Bulgaria
EOOD, Bulgaria Sanofi Winthrop Industrie, Maison Alfort, France; Sanofi Wintrop Industrie, Le Trait, France;
Chinoin Pharmaceutical and Chemical Private, Csanyikvolgy, Hungary
Nadroparin Fraxiparine, Solution for injection, 9 500 anti-Xa IU/ml – 0.6 ml 5 700 IU, -, Pack: 10 Aspen Pharma Trading Limited, Ireland Aspen Notre Dame de Bondeville, France; GlaxoSmithKline Plarmaceuticals S.A., Poland
Nadroparin Fraxiparine sol.inj. 9 500 anti-Xa IU/ml – 0.4 ml, Solution for injection, 3 800, IU, Pack: 10 Aspen Pharma Trading Limited, Ireland Aspen Notre Dame de Bondeville, France; GlaxoSmithKline Plarmaceuticals S.A., Poland
Nadroparin FRAXIPARINE, Solution for injection, 9 500 IU anti-Xa IU/ml – 0.3 ml, -, Pack: 10 Aspen Pharma Trading Limited, Ireland Aspen Notre Dame de Bondeville, France; GlaxoSmithKline Plarmaceuticals S.A., Poland
Pipecuronium ARDUAN, Powder and solvent for solution for injection, 4, mg, Pack: 25 fl. powder + 25 amp. x 2 ml solvent Gedeon Richter Plc., Hungary Gedeon Richter Plc., Hungary
Rocuronium bromide Esmeron, Solution for injection, 10 mg/ml – 5 ml, -, Pack: 10 N.V. Organon, Netherlands
N.V. Organon, Kloosterstraat 6, 5349 AB Oss, The Netherlands; Organon, S.A, Lieu-dit Saint-Charles, 60590 Eragny-sur Epte, France
Atracurium Tracrium, Solution for injection, 10 mg/ml – 2.5 ml, -, Pack: 5 Aspen Pharma Trading Limited, Ireland
GlaxoSmithKline Manufacturing S.p.A., Strada Provinciale Asolana, 90 43056 San Polo di Torrile Parma, Italy
Atracurium Tracrium, Solution for injection, 10 mg/ml – 5 ml, -, Pack: 5 Aspen Pharma Trading Limited, Ireland
GlaxoSmithKline Manufacturing S.p.A., Strada Provinciale Asolana, 90 43056 San Polo di Torrile Parma, Italy
Atracurium Atracurium Kalceks, Solution for injection/infusion, 10 mg/ml - 2.5 ml, -, Pack: 5 AS KALCEKS, Latvia AS Kalceks, Latvia
Atracurium Atracurium Kalceks, Solution for injection/infusion, 10 mg/ml – 5 ml, -, Pack: 5 AS KALCEKS, Latvia AS Kalceks, Latvia
II. The ban from point I is in force until 30 April 2021.