1 | SURGIPHARM LTD | 221 | Atrovent 20 HFA | Human | Foreign | Ipratropium bromide | Ipratropium bromide corresponding to ipratropium
| 9000 | Pressurised Inhalation | RESPIRATORY (INHALATION) | 24 months | Clear, colourless solution in aluminium canister
| R03BB | Other drugs for obstructive airway diseases
| Boehringer Ingelheim international GmbH | Binger StraBe 173 55216 Ingelheim am Rhein Germany | info@boehringer-ingelheim.de | Boehringer Ingelheim Pharma GmbH & Co. KG, | 173 Binger Strasse, 55216, Ingelheim am Rhein,
| Withdrawn | Initiated by the client | GMP Site is Invalid |
2 | NVS KENYA LTD | 263 | Baneocin Powder | | Foreign | Bacitracin+Neomycin | BACITRACIN ZINC+NEOMYCIN SULPHATE PWD 250 IU +
| 1315 | Powder And Solvent For Cutaneous Solution | TOPICAL | 36 months | Baneocin powder is a fine white to yellowish
| D06AX | Other antibiotics for topical use | Sandoz GmbH Kundl | Biochemiestrasse 10A-6250 Kundl / TirolAustria. | winnie.munene@sandoz.com | MONTAVIT GES. MBH | SALZBERGSTR. 96, A-6067 ABSAM, AUSTRIA | Withdrawn | Initiated by the client | GMP Site is Invalid |
3 | SURGIPHARM LTD | 307 | Atrovent 500 mcg UDV | Human | Foreign | Ipratropium bromide | 0.5 mg ipratropium bromide (anhydrous) per 2 ml
| 10090; H95/139 | Inhalation Vapour, Solution | RESPIRATORY (INHALATION) | 24 months | Clear, colourless or almost colourless solution | R03BB | Other drugs for obstructive airway diseases
| Boehringer Ingelheim international GmbH | Binger StraBe 173 55216 Ingelheim am Rhein Germany | info@boehringer-ingelheim.de | LABORATOIRE UNITHER | 80084 AMIENS CEDEX, FRANCE | Withdrawn | Initiated by the client | GMP Site is Invalid |
4 | PHILLIPS THERAPEUTICS LIMITED | 590 | GLURENOR | | Foreign | Gliquidone | 30 mg | 9711 | Tablet | ORAL | 48 months | Flat round white bevel-edged tablets scored on
| A10BB | Blood glucose lowering drugs excluding insulins:
| Laboratori Guidotti S.p.A. | Via Livornese 897 56122- La Vettola Pisa Italy | prijli@menarini.it | A. Menarini Manufacturing Logistics and Services
| Via Campo di Pile, 67100 L Aquila Italy | Withdrawn | Initiated by the client | GMP Site Approved |
5 | SURGIPHARM LTD | 1100 | METALYSE 8 000 U and Solvent | Human | Foreign | Tenecteplase | Tenecteplase 8 000 units. The reconstituted
| 15128 | Powder And Solution For Solution For Injectio | INTRAVENOUS DRIP | 24 months | Powder for IV infusion: white to pale yellow
| B01AD | Antithrombotic agents: Enzymes | Ingelheim Pharmaceuticals (Pty) Ltd | 404 Main Avenue Ferndale Randburg South Africa | fiona.smith@boehringer-ingelheim.com | Boehringer Ingelheim Ellas A.E (Koropi Plant) | 5th KM Paiania-Markopoulo, Koropi Attiki, 19400,
| Withdrawn | Initiated by the client | GMP Site Approved |
6 | SURGIPHARM LTD | 1133 | Mobic 15 mg/1.5 ml Ampoules | Human | Foreign | Meloxicam | 15 mg/1,5 ml | 15127; H2004/004 | Solution For Injection | INTRAMUSCULAR | 36 months | Clear yellow solution with a green tinge,
| M01AC | Non-steroidal
| Boehringer Ingelheim international GmbH | Binger StraBe 173 55216 Ingelheim am Rhein Germany | info@boehringer-ingelheim.de | BOEHRINGER INGELHEIM ESPANA S.A | PRAT DE LA RIBA 50, 08174 SANT CUGAT DEL VALLES,
| Withdrawn | Initiated by the client | GMP Site is Invalid |
7 | PHILLIPS THERAPEUTICS LIMITED | 1136 | SCHERIPROCT | | Foreign | Prednisolone hexanoate / Cinchocain HCl | 1 suppository contains: Prednisolone caproate 1.3
| 4125 | Suppository | RECTAL | 30 Days | yellowish-white suppository | D07XA | Other Combinations of Weak Corticosteroids for
| Bayer Pharma AG | Bayer Pharma AG 13342 Berlin Germany | www.bayer.com | Bayer Health Care Manufacturing s.r.l. Segrate | Via E. Schering 21, 20090, Segrate (Milano), Italy | Withdrawn | Initiated by the client | GMP Site Approved |
8 | STATIM PHARMACEUTICALS LTD | 1289 | Vancocin CP 500 | | Foreign | Vancomycin Hydrochloride | one vial contains vancomycin hydrochloride
| 7116 | Injection | INTRAVENOUS | 24 months | a 10ml size vial sealed with a rubber stopper and
| J01XA | Antibacterials for systemic use:
| Eli Lilly and Company | 16ch.Des Conquelicots P.O Box 580 CH-1214
| moodleyan@lilly.com | VIANEX S.A. /PLANT C | 16th Km Marathonos Avenue, 15351 Pallini, Attica,
| Suspended | Regulatory decision | GMP Site is Invalid |
9 | ENERGIA PHARMA LIMITED | 1445 | Artesiane 20 | Human | Foreign | Artemether | Artemether 20mg/ml | 13634 | Solution For Injection | INTRAMUSCULAR | 36 months | Clear colourless to slightly yellowish oily
| P01BE | Antimalarial Antiprotozoals: Plain Artemisininand
| Dafra Pharma GmbH | Weidboden 2714618 BoningenSwitzerland | info@dafrapharma.com | Rotexmedica GmbH | Bunsenstrasse 4 22940 Trittau Germany | Withdrawn | Initiated by the client | GMP Site Approved |
10 | ENERGIA PHARMA LIMITED | 1449 | Artesiane 40 | Human | Foreign | Artemether | Artemether 40mg/ml | H2009/19741/081 | Solution For Injection | INTRAMUSCULAR | 36 months | Clear colourless to slightly yellowish oily
| P01BE | Antimalarial Antiprotozoals: Plain Artemisininand
| Dafra Pharma GmbH | Weidboden 2714618 BoningenSwitzerland | info@dafrapharma.com | Rotexmedica GmbH | Bunsenstrasse 4 22940 Trittau Germany | Withdrawn | Initiated by the client | GMP Site Approved |