Poskytnuté informace
The Institute states that the Institute has issued since August 2013 in total 5 decisions concerning variations to marketing authorizations of medicinal products for human use in the form of switches of prescription status from Rx to OTC category.
1)
Decision on variation to marketing authorization registered under ref. no. sukls266588/2011 dated 25 September 2013 concerns medicinal product DEXOKET 25 TABLETY, POR. TBL. FLM., registration no. 07/184/06-C and entered into force 17 October 2013. Marketing authorization holder of this medicinal product is the company Menarini International Operations Luxembourg S.A.,1, Avenue de la Gare, Luxembourg. The decision concerns the variation in the form of switch of prescription status.
previously: Rx
now: 4, 10 tablets OTC and 20, 30, 50, 500 tablets Rx.
2)
Decision on variation to marketing authorization registered under ref. no. sukls135123/2013 dated 2 October 2013 concerns medicinal product HIDRASEC 100 MG TVRDÉ TOBOLKY, POR. CPS. DUR, registration no. 49/556/11-C and entered into force 26 October 2013. Marketing authorization holder of this medicinal product is the company Bioprojet Europe Limited, 29 Earlsfort Terrace, Dublin 2, Ireland. The decision concerns the variation in the form of switch of prescription status.
previously: Rx
now: 6, 10 capsules OTC and 20, 100, 500 capsules Rx
3)
Decision on variation to marketing authorization registered under ref. no. sukls136024/2014 dated 12 November 2014 concerns medicinal product OMEPRAZOL FARMAX 20 MG ENTEROSOLVENTNÍ TVRDÁ TOBOLKA, POR. CPS. ETD., registration no. 09/178/14-C and entered into force 29 November 2014. This decision was issued in accordance with Art. 13e letter c) in connection with Art. 13c paragraph 4 of the Commission Regulation (EC) no. 1234/2008 concerning the examination of variations of the term of marketing authorization for medicinal products for human use and veterinary medicinal products amended by Commission Regulation (EU) no. 712/2012.Marketing authorization holder of this medicinal product is the company SVUS Pharma a.s., Smetanovonábřeží 1238/20a, Hradec Králové, the Czech Republic.The decision concerns the variation in the form of switch of prescription status.
previously: Rx
now: 7, 14 capsules (both blister and phial) OTC, and 15, 28, 30, 50, 56, 60, 90, 98, 100, 140, 280 capsules Rx, and hospital pack 500 capsules (blister)Rx, and 5, 15, 28, 30, 50, 56, 60, 90, 100 capsules (phial) Rx
4)
Decision on variation to marketing authorization registered under ref. no. sukls114379/2013 dated 20November 2013 concerns medicinal product PARAMAX RAPID 1 G, POR. TBL. NOB., registration no. 07/414/11-C and entered into force 12 December 2013. Marketing authorization holder of this medicinal product is the companyVitabalans OY, Varastokatu 8, Hämeenlinna, Finland. The decision concerns the variation in the form of switch of prescription status.
previously: 5 tablets OTC and 15, 30, 100 tablets Rx
now: 5, 15 tablets OTC and 30, 100 tablets Rx
5)
Decision on variation to marketing authorization registered under ref. no. sukls37983/2012 dated 7 August 2013 concerns medicinal product SOLVOLAN, POR. SIR., registration no. 52/059/91-S/C and entered into force 4 September 2013. Marketing authorization holder of this medicinal product is the company Krka,d.d.,Novomesto, Šmarješkacesta 6, Novo mesto, Slovenia.The decision concerns the variation in the form of switch of prescription status.
previously: Rx
now: OTC
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