Product Documentation

• View Patient Information Leaflet (PIL- Thalidomide 50mg Hard Capsules)

  Last updated on this site: 22 May 2025

  1.) To register the addition of Glutamine content test procedure

  for the active substance thalidomide used in the manufacturing

  process of the active substance.

  2.) To register the addition of Bluepharma Industria Farmaceutica S.A., Eiras, Rua Adriano Lucas Coimbra,3020-

  430 Portugal as an alternative site responsible for manufacturing of the finished product.

  3.) To register the addition of Bluepharma Industria

  Farmaceutica S.A., Eiras, Rua Adriano Lucas

  Coimbra, 3020-430 Portugal as an alternative site responsible

  for primary packaging of the finished product.

  4.) To register the addition of Bluepharma Industria

  Farmaceutica S.A., Eiras, Rua Adriano Lucas Coimbra, 3020-

  430 Portugal as an alternative site responsible for secondary

  packaging of the finished product.

  5.) To register the addition of Bluepharma Industria

  Farmaceutica S.A., Eiras, Rua Adriano Lucas Coimbra, 3020-

  430 Portugal as an alternative site responsible for batch

  release including batch testing of the finished product.

  6.) To register the addition of Bluepharma Industria

  Farmaceutica S.A., S. Martinho do Bispo Coimbra, 3045-016

  Portugal as an alternative site responsible for batch release

  including batch testing of the finished product.

  7.) To register minor changes in the manufacturing process of

  the finished product to change pre-blending and blending time,

  and rpm.

  8.) To register minor changes to the test procedure for the

  excipient hard gelatine capsules to update the Average mass

  method from n=20 to n=100 caps.

  9.) To register minor changes to the related substance test

  procedure for the finished product to update the RSD number

  of injections.

  10.) To widen the Total thickness specification limit for the

  immediate packaging PVC/PCTFE for the finished product from

  272 micrometres plus/minus 15 micrometres to 277

  micrometres plus/minus 17 micrometres.

  11.) To register the deletion of the non-significant parameter

  Measurements from the immediate

  packaging (LDPE bag) specifications of the finished product.

  12.) To register the deletion of the non-significant parameter

  Thickness from the immediate packaging

  (LDPE bag) specifications of the finished product.

  13.) To register the deletion of the non-significant parameter

  Microbiological control from the immediate packaging (LDPE

  bag) specifications of the finished product.

  Consequentially, the label and leaflet have been updated.

  [14.) IA, B.III.1.b.3 – Register an updated Gelatin TSE certificate from ROUSSELOT from R1-CEP 2000-029-Rev 05 to R1-CEP 2000-029-Rev 06, dated 06 June 2023.

  15.) IA, B.III.1.b.3 – Register an updated Gelatin TSE certificate from TESSENDERLO GROUP N.V., Division PB Leiner (formerly PB Gelatins), from R1-CEP 2000-045-Rev 03 to CEP 2000-045-Rev 06, dated 24 January 2024.

  16.) IA, B.III.1.b.3 – Register an updated Gelatin TSE certificate from NITTA GELATIN INDIA LTD from R1-CEP 2000-344-Rev 02 to R1-CEP 2000-344-Rev 03, dated 10 October 2019.

  17.) IA, B.III.1.b.3 – Register an updated Gelatin TSE certificate from NITTA GELATIN INC., from R1-CEP 2005-217-Rev 00 to R1-CEP 2005-217-Rev 02, dated 16 July 2019.

  18.) IA, B.III.1.b.4 – Register the deletion of gelatin TSE certificate R1-CEP 2004-247-Rev 00 from NITTA GELATIN INC.

  19.) IA, B.III.1.b.4 – Register the deletion of gelatin TSE certificate R1-CEP 2004-320-Rev 00 from NITTA GELATIN INC.

  20.) IA, B.III.1.b.2 – Register a new Gelatin TSE certificate R1-CEP 2008-048-Rev 00, dated 30 January 2014 from a new manufacturer, PIONEER JELLICE INDIA PRIVATE LIMITED.]

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• View Summary of Product Characteristics (SmPC- Thalidomide 50mg Hard Capsules)

  Last updated on this site: 12 May 2025

  Renewal Approval

  View change history