Medicinal Products

BCG VACCINE SSI, prašak i otapalo za suspenziju za injekciju, Cjepivo protiv tuberkuloze (BCG), liofilizirano

Name BCG VACCINE SSI, prašak i otapalo za suspenziju za injekciju, Cjepivo protiv tuberkuloze (BCG), liofilizirano
Marketing Authorisation Number HR-H-365676071
Active Substance Vaccinum Tuberculosis (BCG) Cryodesiccatum
Pharmaceutical Form prašak i otapalo za suspenziju za injekciju
Strength 0,75 mg (2-8 x 106 CFU)
Packaging [MA Number for Packaging] 10 bočica s praškom, u kutiji i 10 bočica s otapalom, u kutiji  [HR-H-365676071-01]
Manufacturer Statens Serum Institut, Copenhagen, Danska
Marketing Authorisation Holder Imunološki zavod d.d., Rockefellerova 2, Zagreb
Marketing Authorisation Date 29.08.2014
MA Period of Validity 29.08.2019
Classification Number UP/I-530-09/13-02/323
Registration Number 381-12-01/70-14-08
Composition 1 ml rekonstituiranog cjepiva sadržava: 0,75 mg (2-8 x 106 CFU) živih, atenuiranih bakterija Mycobacterium bovis (BCG), danski soj 1331
Prescription na recept
Type of prescription ograničeni recept
Distribution u ljekarni
Advertising to general public zabranjeno
ATC Code J07AN01
Medicinal product marketed in the Croatia Trajni prekid opskrbe
SmPC download
PL download
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